Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
Primary Purpose
Huang Qi Gui Zhi Wu Wu Granule, Rheumatoid Arthritis
Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Huang qi gui zhi wu wu granule
Huang qi gui zhi wu wu granule placebo
Sponsored by
About this trial
This is an interventional treatment trial for Huang Qi Gui Zhi Wu Wu Granule
Eligibility Criteria
Inclusion Criteria:
- Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
- moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
- an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
- paid employment or unpaid but measurable work (e.g. caring for a family and home)
Exclusion Criteria:
- combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
- abnormal liver and my kidney function
- pregnancy or have a plan of pregnancy,breast feeding women
- severe chronic or acute disease interfering with therapy attendance
- alcohol or substance abuse
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Placebo group
Arm Description
Patients are given HQGZWWT granules (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
Patients are given HQGZWWT granules placebo (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
Outcomes
Primary Outcome Measures
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
changes of The Disease Activity Score (DAS) 28
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Secondary Outcome Measures
changes of The Disease Activity Score (DAS) 28
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
changes of The Disease Activity Score (DAS) 28
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
changes of The Disease Activity Score (DAS) 28
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
changes of The Disease Activity Score (DAS) 28
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Rate of ACR (American College of Rheumatology) 50
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Health Assessment Questionnaire - Disability Index
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
change score of Patient Assessment of Arthritis Pain
change score of Patient Assessment of Arthritis Pain
VAS score, the range is 0-10, more pain then bigger number
change score of Patient Assessment of Arthritis Pain
VAS score, the range is 0-10, more pain then bigger number
change score of Patient Assessment of Arthritis Pain
VAS score, the range is 0-10, more pain then bigger number
change score of Patient Assessment of Arthritis Pain
VAS score, the range is 0-10, more pain then bigger number
change score of Patient Assessment of Arthritis Pain
VAS score, the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of Patient Global Assessment of Arthritis
the range is 0-10, more pain then bigger number
change score of 36-item Short-Form Health Survey Questionnaire
change score of 36-item Short-Form Health Survey Questionnaire
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
change score of 36-item Short-Form Health Survey Questionnaire
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
change score of 36-item Short-Form Health Survey Questionnaire
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
change score of 36-item Short-Form Health Survey Questionnaire
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
change score of 36-item Short-Form Health Survey Questionnaire
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
change score of AIS Sleep Scale
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
rate of ACR20
rate of ACR20
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR20
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR20
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR20
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR20
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
rate of ACR70
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03593837
Brief Title
Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
Official Title
A Multicenter, Randomized, Double-blind,Placebo-controlled Trial Evaluating the Efficacy and Safety of Huang Qi GuiZhi Wu Wu Tang Granulesin Patients With Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2018 (Anticipated)
Primary Completion Date
December 31, 2019 (Anticipated)
Study Completion Date
March 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Cui xuejun
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Rheumatoid arthritis (RA) is a chronic autoimmune disease characterized by swelling, pain, and synovial damage. Effective methods lack in the treatment of RA. A traditional prescription in use for thousands of years in China, Huang Qi Gui Zhi Wu Wu Tang(HQGZWWT)granule is still chosen to relive pain and prevent joint malformation in RA patients. However, no evidence-based medical research has been organized to assess the effectiveness and safety of HQGZWWT granules for RA.
Detailed Description
Investigators will conduct a multicenter, randomized, double-blind, placebo-controlled clinical trial to determine whether HQGZWWT granules can relieve pain and protect joints. Investigators will randomly divide 120 patients with active arthritis for 3 months. Main measurements include ratio of 50 of ACR (American College of Rheumatology), change of DAS (28) from baseline to 3 months, and SHARP scores of van der Heijde from baseline to 12 months. SecondarymeasurementsincludeACR20, ACR70, Health Assessment Questionnaire-Disability Index (HAQ-DI), arthritis pain score, and Patient Global Assessment of Arthritis. The time points are set as baseline, 2 weeks, 1 month, 2 months, 3 months, 6 months and 12 months. In addition, the rate of change (score) in the ACR50 and DAS28 from the baseline to 2-week, 1-month, 2-month, 6-month, and 12-month follow-up are also the secondary outcome measures.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Huang Qi Gui Zhi Wu Wu Granule, Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Patients are given HQGZWWT granules (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients are given HQGZWWT granules placebo (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg).
Intervention Type
Drug
Intervention Name(s)
Huang qi gui zhi wu wu granule
Intervention Description
Patients are given HQGZWWT granules (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg)
Intervention Type
Drug
Intervention Name(s)
Huang qi gui zhi wu wu granule placebo
Intervention Description
Patients are given HQGZWWT granules placebo (orally twice a day for 3 months and instructed to dissolve one package (4 g) with hot water (200 mg)
Primary Outcome Measure Information:
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 3 months
Title
changes of The Disease Activity Score (DAS) 28
Description
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Time Frame
from baseline to 3 months
Secondary Outcome Measure Information:
Title
changes of The Disease Activity Score (DAS) 28
Description
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Time Frame
from baseline to 2 weeks
Title
changes of The Disease Activity Score (DAS) 28
Description
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Time Frame
from baseline to 1 month
Title
changes of The Disease Activity Score (DAS) 28
Description
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Time Frame
from baseline to 6 months
Title
changes of The Disease Activity Score (DAS) 28
Description
The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×√(28 painful joint count) + 0.28×√(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)
Time Frame
from baseline to 12 months
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 2 weeks
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 1 month
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 2 months
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 6 months
Title
Rate of ACR (American College of Rheumatology) 50
Description
ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by ≥50%, the number of swollen joints by ≥50%, and at least 3 of the following 5 indexes improves by ≥50%:
Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level
Time Frame
at 12 months
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 2 weeks
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 1 month
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 2 months
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 3 months
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 6 months
Title
change score of Health Assessment Questionnaire - Disability Index
Description
The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability
Time Frame
from baseline to 12 months
Title
change score of Patient Assessment of Arthritis Pain
Time Frame
from baseline to 2 weeks
Title
change score of Patient Assessment of Arthritis Pain
Description
VAS score, the range is 0-10, more pain then bigger number
Time Frame
from baseline to 1 month
Title
change score of Patient Assessment of Arthritis Pain
Description
VAS score, the range is 0-10, more pain then bigger number
Time Frame
from baseline to 2 months
Title
change score of Patient Assessment of Arthritis Pain
Description
VAS score, the range is 0-10, more pain then bigger number
Time Frame
from baseline to 3 months
Title
change score of Patient Assessment of Arthritis Pain
Description
VAS score, the range is 0-10, more pain then bigger number
Time Frame
from baseline to 6 months
Title
change score of Patient Assessment of Arthritis Pain
Description
VAS score, the range is 0-10, more pain then bigger number
Time Frame
from baseline to 12 months
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 2 weeks
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 1 month
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 2 months
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 3 months
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 6 months
Title
change score of Patient Global Assessment of Arthritis
Description
the range is 0-10, more pain then bigger number
Time Frame
from baseline to 12 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame
from baseline to 2 weeks
Title
change score of 36-item Short-Form Health Survey Questionnaire
Description
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
Time Frame
from baseline to 1 month
Title
change score of 36-item Short-Form Health Survey Questionnaire
Description
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
Time Frame
from baseline to 2 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Description
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
Time Frame
from baseline to 3 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Description
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
Time Frame
from baseline to 6 months
Title
change score of 36-item Short-Form Health Survey Questionnaire
Description
The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis
Time Frame
from baseline to 12 months
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 2 weeks
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 1 month
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 2 months
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 3 months
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 6 months
Title
change score of AIS Sleep Scale
Description
The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa
Time Frame
from baseline to 12 months
Title
rate of ACR20
Time Frame
at 2 weeks
Title
rate of ACR20
Description
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 1 month
Title
rate of ACR20
Description
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 2 months
Title
rate of ACR20
Description
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 3 months
Title
rate of ACR20
Description
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 6 months
Title
rate of ACR20
Description
ACR20 is met when ≥20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 12 months
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 2 weeks
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 1 month
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 2 months
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 3 months
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 6 months
Title
rate of ACR70
Description
ACR70 is met when ≥70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements
Time Frame
at 12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults with rheumatoid arthritis (score more then 5 of ACR (American College Of Rheumatology) /EULAR (European League Against Rheumatism), 2009 )
moderate-to-severe disease activity (Disease Activity Score for 28-joint counts (DAS28) of more than 3.2
an onset of symptoms within 12 months before enrollment, no prior exposure to more than 10mg oral glucocorticoids or biologic agents
paid employment or unpaid but measurable work (e.g. caring for a family and home)
Exclusion Criteria:
combined with other disease such as adjuvant arthritis, lupus arthritis, osteoarthritis and et al.
abnormal liver and my kidney function
pregnancy or have a plan of pregnancy,breast feeding women
severe chronic or acute disease interfering with therapy attendance
alcohol or substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Qianqian Liang, researcher
Phone
+8618917763347
Email
liangqianqiantcm@126.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
30882703
Citation
Wang Y, Liu Y, Xi Z, Yu Y, Liu L, Mao J, Xiao L, Gu X, Yao M, Cui X, Shi Q, Wang Y, Liang Q. A multicenter, randomized, double-blind, placebo-controlled trial evaluating the efficacy and safety of Huangqi Guizhi Wuwutang granule in patients with rheumatoid arthritis. Medicine (Baltimore). 2019 Mar;98(11):e14888. doi: 10.1097/MD.0000000000014888.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
We'll reach out to this number within 24 hrs