Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

NCT ID: NCT03593837

Last Updated: 2018-07-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-10-01
• Study Completion Date: 2020-03-31

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.

Conditions

Huang Qi Gui Zhi Wu Wu Granule; Rheumatoid Arthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Experimental group

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).

Group Type: EXPERIMENTAL

Huang qi gui zhi wu wu granule

Intervention Type: DRUG

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)

Placebo group

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).

Group Type: PLACEBO_COMPARATOR

Huang qi gui zhi wu wu granule placebo

Intervention Type: DRUG

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)

Interventions

Huang qi gui zhi wu wu granule

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

Huang qi gui zhi wu wu granule placebo

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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cui xuejun

OTHER

Sponsor Role: lead

Responsible Party

Cui xuejun

Principal Investigator base of Traditional Chinese Medicine

Responsibility Role: SPONSOR_INVESTIGATOR

Central Contacts

Qianqian Liang, researcher

Role: CONTACT

liangqianqiantcm@126.com

+8618917763347

References

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.

Reference Type: DERIVED

PMID: 30882703 (View on PubMed)

Other Identifiers

HQGZWWT

Identifier Type: -

Identifier Source: org_study_id