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the purpose of the study is to assess the safety and efficacy of commonly used Homeopathic medicine Rhustoxicodendron in 30 potency in the treatment of Rheumatoid arthritis.
it is a multicenter phase 2 ,double blind study in patient with active Rheumatoid arthritis ,there are 2 group in the study A and B ,where group A receive Rhustoxicodendron in 30 potency the first dose will administered orally (1/2 ml)after the completion of case taking ,and repeated every 7th day for 5 month and on the other hand group B receive placebo orally in (1/2 ml) at same interval for same period .
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo | Placebo Comparator | 1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month . |
|
| Rhustoxicodendron 30 | Active Comparator | 1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rhustoxicodendron 30 | Drug | 1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders). | number of subject with ACR criteria improvement consisting of ACR 20,ACR50,ACR70 reduction in tender and swollen joint counts and 20%,50%,70% improvement respectively in 3 of the following 5 criteria .
| 6 weeks upto 24 week |
| Measure | Description | Time Frame |
|---|---|---|
| mean change from baseline in tender joint count. | 6 weeks upto 24 week | |
| mean change from baseline in swollen joint. | 6 weeks upto 24 week | |
| mean change from baseline in physician global assessment of disease activity. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| seenia sharma, B.H.M.S | Contact | 0091-7837144332 | drseeniasharma@gmail.com | |
| mukesh k singh, B.H.M.S | Contact | 0091-9463131239 | drmukeshkrsingh@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| ravinder kochhar, MD hom | Healthcare Homoeo Charitable Society | Principal Investigator |
| mukesh k singh, B.H.M.S | health care homoeo charitable society | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gupta Homoeo Clinic | Recruiting | Delhi | National Capital Territory of Delhi | India |
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| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D000431 | Ethanol |
| ID | Term |
|---|---|
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| placebo | Drug | 1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally. |
|
|
mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm) |
| every 6 weeks upto 24 week |
| mean change from baseline in patient global assessment of disease . | mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm) | 6 weeks upto 24 week |
| mean change from baseline in subject assessment of pain using VAS from 0-100 mm | 6 weeks upto 24 week |
| mean change from baseline in ESR | 6 weeks upto 24 week |
| mean change from baseline in disability index of the health assessment Questionnaire (HAQ) | 6 weeks upto 24 week |
| Kochhar Clinic | Recruiting | Ludhiana | Punjab | 141001 | India |
|
| D003240 |
| Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |