- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03593837
Efficacy and Safety of HQGZWWT Patients With Rheumatoid Arthritis
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
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / 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).
|
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).
|
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)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
at 3 months
|
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)
|
from baseline to 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
from baseline to 2 weeks
|
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)
|
from baseline to 1 month
|
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)
|
from baseline to 6 months
|
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)
|
from baseline to 12 months
|
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 |
at 2 weeks
|
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 |
at 1 month
|
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 |
at 2 months
|
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 |
at 6 months
|
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 |
at 12 months
|
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
|
from baseline to 2 weeks
|
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
|
from baseline to 1 month
|
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
|
from baseline to 2 months
|
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
|
from baseline to 3 months
|
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
|
from baseline to 6 months
|
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
|
from baseline to 12 months
|
change score of Patient Assessment of Arthritis Pain
Time Frame: from baseline to 2 weeks
|
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
|
from baseline to 1 month
|
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
|
from baseline to 2 months
|
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
|
from baseline to 3 months
|
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
|
from baseline to 6 months
|
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
|
from baseline to 12 months
|
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
|
from baseline to 2 weeks
|
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
|
from baseline to 1 month
|
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
|
from baseline to 2 months
|
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
|
from baseline to 3 months
|
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
|
from baseline to 6 months
|
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
|
from baseline to 12 months
|
change score of 36-item Short-Form Health Survey Questionnaire
Time Frame: from baseline to 2 weeks
|
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
|
from baseline to 1 month
|
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
|
from baseline to 2 months
|
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
|
from baseline to 3 months
|
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
|
from baseline to 6 months
|
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
|
from baseline to 12 months
|
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
|
from baseline to 2 weeks
|
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
|
from baseline to 1 month
|
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
|
from baseline to 2 months
|
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
|
from baseline to 3 months
|
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
|
from baseline to 6 months
|
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
|
from baseline to 12 months
|
rate of ACR20
Time Frame: at 2 weeks
|
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
|
at 1 month
|
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
|
at 2 months
|
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
|
at 3 months
|
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
|
at 6 months
|
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
|
at 12 months
|
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
|
at 2 weeks
|
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
|
at 1 month
|
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
|
at 2 months
|
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
|
at 3 months
|
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
|
at 6 months
|
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
|
at 12 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ANTICIPATED)
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HQGZWWT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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