Back to resultsPost-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Not yet recruiting
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Wangbi granules
Wangbi granules simulant
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis
Eligibility Criteria
Inclusion Criteria:
- Age 18-75 years.
- Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
- Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
- Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
- Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
- Voluntary participation and signed written informed consent.
Exclusion Criteria:
- Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
- Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr <60ml/min) and other important organ function impairment or hematological system diseases.
- Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
- Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
- Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
- Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
treatment group
control group
Arm Description
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Outcomes
Primary Outcome Measures
DAS28
Disease mobility score for 28 joints, higher scores indicate higher disease activity
Secondary Outcome Measures
Fatigue Scale-14
assessing the patient's fatigue level, the higher the score, the more severe the fatigue
visual analogue scale
Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain
Full Information
NCT ID
NCT05540938
First Posted
September 10, 2022
Last Updated
April 3, 2023
Sponsor
China-Japan Friendship Hospital
Collaborators
Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The 980th Hospital of PLA Joint Logistics Support Force, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Southwest Hospital, China
1. Study Identification
Unique Protocol Identification Number
NCT05540938
Brief Title
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Official Title
Reevaluation of Original Research Results of Integrated Traditional Chinese and Western Medicine and Transformation of Hospital Preparations: Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 15, 2023 (Anticipated)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital
Collaborators
Peking Union Medical College Hospital, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine, The 980th Hospital of PLA Joint Logistics Support Force, The Second Affiliated Hospital of Zhejiang Chinese Medical University, Southwest Hospital, China
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
5. Study Description
Brief Summary
The group used a randomized controlled trial to conduct a post-marketing re-evaluation study of Wangbi granules. The study was conducted to observe the degree of clinical remission in rheumatoid arthritis patients with low disease activity after standard methotrexate and tofacitinib citrate treatment, using a combination of Chinese and Western medicine treatment with Wangbi granules. The study aims to provide evidence-based medical evidence to improve the clinical efficacy of rheumatoid arthritis, enhance the depth of remission, and improve the diagnosis and treatment of rheumatoid arthritis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
340 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
treatment group
Arm Type
Experimental
Arm Description
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Intervention Type
Drug
Intervention Name(s)
Wangbi granules
Intervention Description
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules 12.0g tid, treatment course 3 months.
Intervention Type
Drug
Intervention Name(s)
Wangbi granules simulant
Intervention Description
Methotrexate 7.5-15mg qw plus tofacitab 5mg bid, combined with Wangbi granules simulant 12.0g tid, treatment course 3 months.
Primary Outcome Measure Information:
Title
DAS28
Description
Disease mobility score for 28 joints, higher scores indicate higher disease activity
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Fatigue Scale-14
Description
assessing the patient's fatigue level, the higher the score, the more severe the fatigue
Time Frame
12 weeks
Title
visual analogue scale
Description
Patients score according to the level of pain they feel, there are 10 scales from 0-10, with 0 representing no pain and 10 representing severe pain
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age 18-75 years.
Meeting the 1987 ACR or 2010 ACR/EULAR diagnostic criteria.
Meeting the diagnostic criteria of Chinese medicine for Kidney deficiency and dampness and stasis blocking channels in Chinese medicine.
Rheumatoid arthritis disease activity score DAS28 of 2.6 to 3.2.
Regularly taking methotrexate 7.5-15 mg qw and tofacitab 5 mg bid before enrollment and stable treatment regimen for more than 4 weeks.
Voluntary participation and signed written informed consent.
Exclusion Criteria:
Patients taking immunosuppressive drugs other than traditional DMARDs for rheumatoid arthritis within 3 months prior to enrollment (traditional DMARDs include hydroxychloroquine sulfate, methotrexate, salazosulfapyridine tablets, and raglan polysaccharide tablets, among others).
Organ transplant recipients, patients with malignant tumors, patients with heart, brain, liver (ALT/AST > 3 times the normal upper limit), kidney (Ccr <60ml/min) and other important organ function impairment or hematological system diseases.
Psychiatric disorders such as cognitive disorders, depression, anxiety disorders, somatic dysfunction, cerebral infarction, cerebral hemorrhage, epilepsy, TIA, myelitis, demyelinating lesions and other central neurological disorders, or peripheral neurological disorders such as restless legs syndrome. peripheral neurological disorders such as restless legs syndrome.
Women and men who are pregnant or breastfeeding or who are planning a pregnancy within the next 6 months; during the trial or within 1 month of the last dose Women of childbearing age who are unable or unwilling to use adequate contraception, or whose spouse is unwilling to use contraception, within one month of the last dose or within one month of the last dose are unwilling to use contraception.
Persons with a BMI greater than 35 (kg/m2), allergic to the test drug, or participating in other clinical trials.
Other conditions deemed by the investigator to be inappropriate for trial participation (out-of-town patients unable to be followed up, etc.).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zihan Wang, Dr
Phone
+8618810902100
Email
wzhbucm@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis
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