Clinical trial NCT03593837: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Huang Qi Gui Zhi Wu Wu Granule
Rheumatoid Arthritis
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
First posted: 2018-07-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 3 months
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 3 months
Secondary outcomes:
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 2 weeks
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 1 month
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 6 months
measure: changes of The Disease Activity Score (DAS) 28
timeFrame: from baseline to 12 months
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 2 weeks
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 1 month
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 2 months
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 6 months
measure: Rate of ACR (American College of Rheumatology) 50
timeFrame: at 12 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 2 weeks
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 1 month
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 2 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 3 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 6 months
measure: change score of Health Assessment Questionnaire - Disability Index
timeFrame: from baseline to 12 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 2 weeks
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 1 month
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 2 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 3 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 6 months
measure: change score of Patient Assessment of Arthritis Pain
timeFrame: from baseline to 12 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 2 weeks
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 1 month
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 2 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 3 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 6 months
measure: change score of Patient Global Assessment of Arthritis
timeFrame: from baseline to 12 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 2 weeks
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 1 month
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 2 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 3 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 6 months
measure: change score of 36-item Short-Form Health Survey Questionnaire
timeFrame: from baseline to 12 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 2 weeks
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 1 month
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 2 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 3 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 6 months
measure: change score of AIS Sleep Scale
timeFrame: from baseline to 12 months
measure: rate of ACR20
timeFrame: at 2 weeks
measure: rate of ACR20
timeFrame: at 1 month
measure: rate of ACR20
timeFrame: at 2 months
measure: rate of ACR20
timeFrame: at 3 months
measure: rate of ACR20
timeFrame: at 6 months
measure: rate of ACR20
timeFrame: at 12 months
measure: rate of ACR70
timeFrame: at 2 weeks
measure: rate of ACR70
timeFrame: at 1 month
measure: rate of ACR70
timeFrame: at 2 months
measure: rate of ACR70
timeFrame: at 3 months
measure: rate of ACR70
timeFrame: at 6 months
measure: rate of ACR70
timeFrame: at 12 months
Other outcomes:
Locations:
Study officials:
References:
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.