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Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

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ClinicalTrials.gov Identifier: NCT03593837
Recruitment Status : Not yet recruiting
First Posted : July 20, 2018
Last Update Posted : July 25, 2018
Sponsor:
Information provided by (Responsible Party):
Cui xuejun, Shanghai University of Traditional Chinese Medicine

Tracking Information
First Submitted Date  ICMJE July 10, 2018
First Posted Date  ICMJE July 20, 2018
Last Update Posted Date July 25, 2018
Estimated Study Start Date  ICMJE October 1, 2018
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 3 months ]
    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
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 3 months ]
    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×√(28 painful joint count) + 0.28×√(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)
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • 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 ]
  • changes of the van der Heijde modified Sharp score [ Time Frame: from baseline to 3 months ]
Change History Complete list of historical versions of study NCT03593837 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2018)
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 2 weeks ]
    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×√(28 painful joint count) + 0.28×√(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)
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 1 month ]
    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×√(28 painful joint count) + 0.28×√(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)
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 6 months ]
    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×√(28 painful joint count) + 0.28×√(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)
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 12 months ]
    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×√(28 painful joint count) + 0.28×√(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)
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 weeks ]
    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
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 1 month ]
    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
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 months ]
    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
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 6 months ]
    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
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 12 months ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 weeks ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 1 month ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 months ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 3 months ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 6 months ]
    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
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 12 months ]
    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
  • 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 1 month ]
    VAS score, the range is 0-10, more pain then bigger number
  • change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 2 months ]
    VAS score, the range is 0-10, more pain then bigger number
  • change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 3 months ]
    VAS score, the range is 0-10, more pain then bigger number
  • change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 6 months ]
    VAS score, the range is 0-10, more pain then bigger number
  • change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 12 months ]
    VAS score, the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 2 weeks ]
    the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 1 month ]
    the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 2 months ]
    the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 3 months ]
    the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 6 months ]
    the range is 0-10, more pain then bigger number
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 12 months ]
    the range is 0-10, more pain then bigger number
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 weeks ]
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 1 month ]
    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
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 months ]
    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
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 3 months ]
    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
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 6 months ]
    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
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 12 months ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 2 weeks ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 1 month ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 2 months ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 3 months ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 6 months ]
    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
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 12 months ]
    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
  • rate of ACR20 [ Time Frame: at 2 weeks ]
  • rate of ACR20 [ Time Frame: at 1 month ]
    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
  • rate of ACR20 [ Time Frame: at 2 months ]
    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
  • rate of ACR20 [ Time Frame: at 3 months ]
    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
  • rate of ACR20 [ Time Frame: at 6 months ]
    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
  • rate of ACR20 [ Time Frame: at 12 months ]
    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
  • rate of ACR70 [ Time Frame: at 2 weeks ]
    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
  • rate of ACR70 [ Time Frame: at 1 month ]
    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
  • rate of ACR70 [ Time Frame: at 2 months ]
    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
  • rate of ACR70 [ Time Frame: at 3 months ]
    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
  • rate of ACR70 [ Time Frame: at 6 months ]
    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
  • rate of ACR70 [ Time Frame: at 12 months ]
    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
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2018)
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 2 weeks ]
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 1 month ]
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 6 months ]
  • changes of The Disease Activity Score (DAS) 28 [ Time Frame: from baseline to 12 months ]
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 weeks ]
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 1 month ]
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 2 months ]
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 6 months ]
  • Rate of ACR (American College of Rheumatology) 50 [ Time Frame: at 12 months ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 weeks ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 1 month ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 2 months ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 3 months ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 6 months ]
  • change score of Health Assessment Questionnaire - Disability Index [ Time Frame: from baseline to 12 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 1 month ]
  • 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 3 months ]
  • change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 6 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 2 weeks ]
  • 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 2 months ]
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 3 months ]
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 6 months ]
  • change score of Patient Global Assessment of Arthritis [ Time Frame: from baseline to 12 months ]
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 weeks ]
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 1 month ]
  • 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 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 6 months ]
  • change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 12 months ]
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 2 weeks ]
  • change score of AIS Sleep Scale [ 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 3 months ]
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 6 months ]
  • change score of AIS Sleep Scale [ Time Frame: from baseline to 12 months ]
  • rate of ACR20 [ Time Frame: at 2 weeks ]
  • rate of ACR20 [ Time Frame: at 1 month ]
  • rate of ACR20 [ Time Frame: at 2 months ]
  • rate of ACR20 [ Time Frame: at 3 months ]
  • rate of ACR20 [ Time Frame: at 6 months ]
  • rate of ACR20 [ Time Frame: at 12 months ]
  • rate of ACR70 [ Time Frame: at 2 weeks ]
  • rate of ACR70 [ Time Frame: at 1 month ]
  • rate of ACR70 [ Time Frame: at 2 months ]
  • rate of ACR70 [ Time Frame: at 3 months ]
  • rate of ACR70 [ Time Frame: at 6 months ]
  • rate of ACR70 [ Time Frame: at 12 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Huang Qi Gui Zhi Wu Wu Granule
  • Rheumatoid Arthritis
Intervention  ICMJE
  • 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)
  • 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)
Study Arms  ICMJE
  • Experimental: 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).
    Intervention: Drug: Huang qi gui zhi wu wu granule
  • Placebo Comparator: 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).
    Intervention: Drug: Huang qi gui zhi wu wu granule placebo
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 10, 2018)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 31, 2020
Estimated Primary Completion Date December 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Qianqian Liang, researcher +8618917763347 liangqianqiantcm@126.com
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03593837
Other Study ID Numbers  ICMJE HQGZWWT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Cui xuejun, Shanghai University of Traditional Chinese Medicine
Study Sponsor  ICMJE Cui xuejun
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Shanghai University of Traditional Chinese Medicine
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP