Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

Cui xuejun

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Huang Qi Gui Zhi Wu Wu Granule; Rheumatoid Arthritis

Treatments: Drug: Huang qi gui zhi wu wu granule placebo; Drug: Huang qi gui zhi wu wu granule

Study type: Interventional

Funder types: Other

Identifiers

NCT03593837

HQGZWWT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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100 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

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).

Treatment:

Drug: Huang qi gui zhi wu wu granule

Placebo group

Placebo Comparator group

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).

Treatment:

Drug: Huang qi gui zhi wu wu granule placebo