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Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03593837
Date of registration:	10/07/2018
Prospective Registration:	Yes
Primary sponsor:	Cui xuejun
Public title:	Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
Scientific 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
Date of first enrolment:	October 1, 2018
Target sample size:	100
Recruitment status:	Unknown status
URL:	https://clinicaltrials.gov/show/NCT03593837
Study type:	Interventional
Study design:	Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
Phase:	Phase 2/Phase 3

Countries of recruitment

Contacts

Name:	Qianqian Liang, researcher
Address:
Telephone:	+8618917763347
Email:	liangqianqiantcm@126.com
Affiliation:

Key inclusion & exclusion 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

Age minimum: 18 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Rheumatoid Arthritis

Huang Qi Gui Zhi Wu Wu Granule

Intervention(s)

Drug: Huang qi gui zhi wu wu granule

Drug: Huang qi gui zhi wu wu granule placebo

Primary Outcome(s)

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 3 months]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 3 months]

Secondary Outcome(s)

change score of AIS Sleep Scale [Time Frame: from baseline to 6 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 2 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 12 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 6 months]

rate of ACR70 [Time Frame: at 6 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 3 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 6 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 2 weeks]

rate of ACR20 [Time Frame: at 3 months]

rate of ACR70 [Time Frame: at 2 weeks]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 1 month]

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 2 months]

rate of ACR20 [Time Frame: at 12 months]

rate of ACR20 [Time Frame: at 6 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 1 month]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 1 month]

change score of AIS Sleep Scale [Time Frame: from baseline to 2 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 2 weeks]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 12 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 6 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 2 months]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 2 weeks]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 3 months]

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 1 month]

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 12 months]

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 2 weeks]

rate of ACR20 [Time Frame: at 2 weeks]

rate of ACR70 [Time Frame: at 3 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 2 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 3 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 3 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 2 months]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 3 months]

rate of ACR20 [Time Frame: at 1 month]

rate of ACR70 [Time Frame: at 1 month]

rate of ACR70 [Time Frame: at 12 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 2 weeks]

change score of Patient Assessment of Arthritis Pain [Time Frame: from baseline to 1 month]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 1 month]

change score of Patient Global Assessment of Arthritis [Time Frame: from baseline to 12 months]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 6 months]

Rate of ACR (American College of Rheumatology) 50 [Time Frame: at 6 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 12 months]

change score of 36-item Short-Form Health Survey Questionnaire [Time Frame: from baseline to 6 months]

rate of ACR20 [Time Frame: at 2 months]

change score of AIS Sleep Scale [Time Frame: from baseline to 1 month]

change score of AIS Sleep Scale [Time Frame: from baseline to 12 months]

change score of Health Assessment Questionnaire - Disability Index [Time Frame: from baseline to 2 weeks]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 12 months]

changes of The Disease Activity Score (DAS) 28 [Time Frame: from baseline to 2 weeks]

rate of ACR70 [Time Frame: at 2 months]

Secondary ID(s)

HQGZWWT

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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