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Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Huang Qi Gui Zhi Wu Wu Granule Rheumatoid Arthritis Drug: Huang qi gui zhi wu wu granule Drug: Huang qi gui zhi wu wu granule placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Estimated Study Start Date : October 1, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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)

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).
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)




Primary Outcome Measures :
  1. 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


  2. 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)


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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)

  5. 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


  6. 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


  7. 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


  8. 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


  9. 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


  10. 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

  11. 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

  12. 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

  13. 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

  14. 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

  15. 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

  16. change score of Patient Assessment of Arthritis Pain [ Time Frame: from baseline to 2 weeks ]
  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. 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

  24. 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

  25. 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

  26. 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

  27. 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

  28. change score of 36-item Short-Form Health Survey Questionnaire [ Time Frame: from baseline to 2 weeks ]
  29. 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

  30. 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

  31. 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

  32. 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

  33. 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

  34. 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

  35. 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

  36. 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

  37. 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

  38. 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

  39. 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

  40. rate of ACR20 [ Time Frame: at 2 weeks ]
  41. 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

  42. 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

  43. 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

  44. 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

  45. 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

  46. 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

  47. 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

  48. 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

  49. 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

  50. 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

  51. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03593837


Contacts
Layout table for location contacts
Contact: Qianqian Liang, researcher +8618917763347 liangqianqiantcm@126.com

Sponsors and Collaborators
Cui xuejun

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Cui xuejun, Principal Investigator base of Traditional Chinese Medicine, Shanghai University of Traditional Chinese Medicine
ClinicalTrials.gov Identifier: NCT03593837     History of Changes
Other Study ID Numbers: HQGZWWT
First Posted: July 20, 2018    Key Record Dates
Last Update Posted: July 25, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases