A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis

Study Overview
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Brief Summary
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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.

Detailed Description
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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 .

Official Title
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A Multicentric,Double-blind,Placebo Controlled,Phase-2 Study to Assess the Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis .

Conditions
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Rheumatoid Arthritis.

Intervention / Treatment
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* Drug: Rhustoxicodendron 30
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: those who will provide written consent to participate in the study patient willing to turn up for 7th day follow up patient who are willing and compliance to the study those who are between 25 to 60 years . patient who are willing and compliance to the study . ESR more then 28 mm. Exclusion Criteria: Participating as a subject in any other clinical research study. Children below the age of 25years. Female subject who are pregnant or planning for pregnancy within 6 month. History of seizures Breast feeding women's. Patient on treatment for life threatening illness like cancer aids etc. Patient should not have any congenital abnormality or patient should not have undergone any operative procedure as consequences of RA.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: placebo<br>1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month . | Drug: placebo<br>* 1/2 ml of dispensing alcohol is administered every 7 day for 5 month orally.<br>* Other names: dispensing alcohol;|
| Active Comparator: Rhustoxicodendron 30<br>1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month. | Drug: Rhustoxicodendron 30<br>* 1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.<br>* Other names: poison ivy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 . physician global assessment of disease activity's. patient global assessment of disease activity's. subject assessment of pain subject assessment of function disability via health assessment questionnaire[HAQ] acute phase reactant ESR every 6 weeks upto 24 week | 6 weeks upto 24 week | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RA