Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03593837
• Other study ID #: HQGZWWT
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: October 1, 2018
• Est. completion date: March 31, 2020

Study information

• Verified date: July 2018
• Source: Shanghai University of Traditional Chinese Medicine
• Contact: Qianqian Liang, researcher
• Phone: +8618917763347
• Email: liangqianqiantcm[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: March 31, 2020
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Huang Qi Gui Zhi Wu Wu Granule
• Rheumatoid Arthritis

Intervention

Drug:
• 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)
• 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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cui xuejun

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 3 months
Primary	changes of The Disease Activity Score (DAS) 28	The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×v(28 painful joint count) + 0.28×v(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)	from baseline to 3 months
Secondary	changes of The Disease Activity Score (DAS) 28	The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×v(28 painful joint count) + 0.28×v(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)	from baseline to 2 weeks
Secondary	changes of The Disease Activity Score (DAS) 28	The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×v(28 painful joint count) + 0.28×v(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)	from baseline to 1 month
Secondary	changes of The Disease Activity Score (DAS) 28	The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×v(28 painful joint count) + 0.28×v(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)	from baseline to 6 months
Secondary	changes of The Disease Activity Score (DAS) 28	The DAS28 is an index calculating the number of painful and swollen joints (28 joints, i.e. shoulders, elbows, wrists, metacarpophalangeal and proximal interphalangeal joints, and knees), erythrocyte sedimentation rate and the score of global assessment. The formula of DAS 28 is 0.56×v(28 painful joint count) + 0.28×v(28 swollen joint count) + 0.70× (ln ESR) + 0.014 ×GH. ESR refers to erythrocyte sedimentation rate. GH is the patient's general health visual analog scale (0-10 mm)	from baseline to 12 months
Secondary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 2 weeks
Secondary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 1 month
Secondary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 2 months
Secondary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 6 months
Secondary	Rate of ACR (American College of Rheumatology) 50	ACR (American College of Rheumatology) 50 is a standard to describe RA symptoms. ACR 50 is met when the number of tender joints reduces by =50%, the number of swollen joints by =50%, and at least 3 of the following 5 indexes improves by =50%: Patient's assessment on arthritis pain using a visual analogue scale (VAS) of 0-100 mm, Patient global assessment on disease activity using VAS scale (0-10), Patient's assessment on physical function and disability (Health Assessment Questionnaire - Disability Index (HAQ-DI)), Acute phase reactant value, such as erythrocyte sedimentation rate (ESR) or C-reactive Protein (CRP) level	at 12 months
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 2 weeks
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 1 month
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 2 months
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 3 months
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 6 months
Secondary	change score of Health Assessment Questionnaire - Disability Index	The HAQ-DI measure shave eight dimensions of functional activity: pruning, dressing, rising, eating, walking, personal hygiene, reach, grip, and other routine activities. Each item has 4 degrees ranging from 0 to 3. "0" refers to "no functional difficulty", "1" to a bit of functional difficulty, "2" to very much functional difficulty, and "3" to no ability to work. HAQ-DI score 0-1 means mild to moderate functional difficulty; 1-2 means moderate to severe disability; and 2-3 means generally severe disability	from baseline to 12 months
Secondary	change score of Patient Assessment of Arthritis Pain		from baseline to 2 weeks
Secondary	change score of Patient Assessment of Arthritis Pain	VAS score, the range is 0-10, more pain then bigger number	from baseline to 1 month
Secondary	change score of Patient Assessment of Arthritis Pain	VAS score, the range is 0-10, more pain then bigger number	from baseline to 2 months
Secondary	change score of Patient Assessment of Arthritis Pain	VAS score, the range is 0-10, more pain then bigger number	from baseline to 3 months
Secondary	change score of Patient Assessment of Arthritis Pain	VAS score, the range is 0-10, more pain then bigger number	from baseline to 6 months
Secondary	change score of Patient Assessment of Arthritis Pain	VAS score, the range is 0-10, more pain then bigger number	from baseline to 12 months
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 2 weeks
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 1 month
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 2 months
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 3 months
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 6 months
Secondary	change score of Patient Global Assessment of Arthritis	the range is 0-10, more pain then bigger number	from baseline to 12 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire		from baseline to 2 weeks
Secondary	change score of 36-item Short-Form Health Survey Questionnaire	The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis	from baseline to 1 month
Secondary	change score of 36-item Short-Form Health Survey Questionnaire	The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis	from baseline to 2 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire	The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis	from baseline to 3 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire	The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis	from baseline to 6 months
Secondary	change score of 36-item Short-Form Health Survey Questionnaire	The SF-36 measures eight dimensions, including vitality, body function, body aches, general health perceptions, body functions, emotional function, social function and mental health. SF-36 is widely used in the evaluation of quality of life in patients with rheumatoid arthritis	from baseline to 12 months
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 2 weeks
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 1 month
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 2 months
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 3 months
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 6 months
Secondary	change score of AIS Sleep Scale	The Athens Insomnia Scale (AIS) can help patients quantitatively self-evaluate sleep disorders with a psychometric instrument that includes eight indicators for sleep induction, awakenings during the night, final awakening, total sleep duration, sleep quality during the night, wellbeing during the night, functioning capacity during the day time, and sleepiness during the day time. The score for each indicator ranges from 0 to 3, and the total score is 24 points. The higher the score, the worse the sleep quality, and vise versa	from baseline to 12 months
Secondary	rate of ACR20		at 2 weeks
Secondary	rate of ACR20	ACR20 is met when =20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 1 month
Secondary	rate of ACR20	ACR20 is met when =20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 2 months
Secondary	rate of ACR20	ACR20 is met when =20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 3 months
Secondary	rate of ACR20	ACR20 is met when =20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 6 months
Secondary	rate of ACR20	ACR20 is met when =20% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 12 months
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 2 weeks
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 1 month
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 2 months
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 3 months
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 6 months
Secondary	rate of ACR70	ACR70 is met when =70% is achieved in the reduction of tender joint number, swollen joint number, and indexes of 3 of the 5 other measurements	at 12 months