Back to resultsEfficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
Primary Purpose
Acute Gout
Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
HuZhen Capsule
Placebo Capsule
Sponsored by
About this trial
This is an interventional treatment trial for Acute Gout
Eligibility Criteria
Inclusion Criteria:
- Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
- Acute attack of gout no longer than 2 days.
- Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
- Age 18-65 years with informed consent.
Exclusion Criteria:
- Chronic gouty arthritis.
- Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
- Anti-inflammatory medication for the treatment of acute gout.
- Pregnant or breastfeeding women.
- History of severe allergy, including diclofenac sodium.
- Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
- Fever ( T>38.5 ℃)
Sites / Locations
- Guang'anmen Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
HuZhen Capsule
Placebo Capsule
Arm Description
The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.
Placebo appearance, content color and taste should be consistent with HuZhen Capsule.
Outcomes
Primary Outcome Measures
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
Secondary Outcome Measures
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
Refer to the"Guidline for Clinical Study of New Chinese Medicines "
Change in C-reactive protein (CRP) from baseline to 72 hours
Units of Measure:mg/L
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
Units of Measure:mm/hour
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
The number of adverse events related to treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02674776
Brief Title
Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
Official Title
A Clinical Trial About the Efficacy and Safety of HuZhen Capsule in Treating Patients With Acute Gout: A 72 Hours, Multi-center, Randomized, Double-blind, Parallel Placebo Compared Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Quan Jiang
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is a multi-center, double-blind, randomized, parallel controlled trial. Patients with acute gout will be enrolled and randomly allocated into 2 groups: HuZhen capsule treatment group and Placebo control group. Randomization codes were established by the biostatistician. Observe will be followed for 3 days (72 hours) after the onset. Change of VAS score from baseline, proportion of improvement with damp-heat retention, change in C-reactive protein (CRP) and erythrocyte sedimentation rate ( ESR) from baseline, change in white blood cell count in whole blood cell analysis from baseline, and the number of adverse events will be monitored and compared between each groups.
Detailed Description
The test group will be given HuZhen capsule 1.6g three times per day,the control group will be given placebo 1.6g three times per day. The invention will last 3 days.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Gout
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
480 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
HuZhen Capsule
Arm Type
Experimental
Arm Description
The main elements of HuZhen Capsule include Polygonum cuspidatum, Ligustrum lucidum etc.
Arm Title
Placebo Capsule
Arm Type
Placebo Comparator
Arm Description
Placebo appearance, content color and taste should be consistent with HuZhen Capsule.
Intervention Type
Drug
Intervention Name(s)
HuZhen Capsule
Other Intervention Name(s)
capsule A
Intervention Description
Patients should take 4 tablet once and 3 times per day for 3 days.
Intervention Type
Drug
Intervention Name(s)
Placebo Capsule
Other Intervention Name(s)
capsule B
Intervention Description
Patients should take 4 tablet once and 3 times per day for 3 days.
Primary Outcome Measure Information:
Title
Change of VAS (visual analog scale) score from baseline to 72 Hours after onset
Time Frame
baseline,72 hours
Secondary Outcome Measure Information:
Title
Proportion of participants with improvement in acute gout at 72 hours post-dose using the criteria for the diagnosis of damp-heat retention
Description
Refer to the"Guidline for Clinical Study of New Chinese Medicines "
Time Frame
72 hours
Title
Change in C-reactive protein (CRP) from baseline to 72 hours
Description
Units of Measure:mg/L
Time Frame
baseline,72 hours
Title
Change in erythrocyte sedimentation rate ( ESR) from baseline to 72 hours
Description
Units of Measure:mm/hour
Time Frame
baseline,72 hours
Title
Change in white blood cell count in whole blood cell analysis from baseline to 72 hours
Time Frame
baseline,72 hours
Title
The number of adverse events related to treatment
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Score is equal to or larger than 40cm on the 0-100cm VAS pain scale.
Acute attack of gout no longer than 2 days.
Participant with acute gout is diagnosed as "damp-heat retention" by Traditional Chinese medicine.
Age 18-65 years with informed consent.
Exclusion Criteria:
Chronic gouty arthritis.
Pseudogout, acute rheumatic fever and suppurative arthritis, traumatic arthritis, erysipelas, meander rheumatism and other arthritis.
Anti-inflammatory medication for the treatment of acute gout.
Pregnant or breastfeeding women.
History of severe allergy, including diclofenac sodium.
Serum creatinine is higher than the upper normal limit. ALT or AST is higher than the upper normal limit for two times.
Fever ( T>38.5 ℃)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jiang Quan, Doctor
Organizational Affiliation
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Guang'anmen Hospital
City
Bei Jing
State/Province
Beijing
ZIP/Postal Code
100052
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of HuZhen Capsule for Treatment of Patients With Acute Gout
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