A Safety and Efficacy of Homeopathic Medicine Rhus Toxicodendron 30 in the Treatment of Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis.
- Interventions
- Drug: placeboDrug: Rhustoxicodendron 30
- Registration Number
- NCT01905735
- Lead Sponsor
- Healthcare Homoeo Charitable Society
- Brief Summary
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
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 .
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description placebo placebo 1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month . Rhustoxicodendron 30 Rhustoxicodendron 30 1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
- Primary Outcome Measures
Name Time Method Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders). 6 weeks upto 24 week 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 .
1. physician global assessment of disease activity's.
2. patient global assessment of disease activity's.
3. subject assessment of pain
4. subject assessment of function disability via health assessment questionnaire\[HAQ\]
5. acute phase reactant ESR every 6 weeks upto 24 week
- Secondary Outcome Measures
Name Time Method 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. every 6 weeks upto 24 week mean change from baseline in physician assessment of disease activity via visual analog scale(0-100 mm)
mean change from baseline in patient global assessment of disease . 6 weeks upto 24 week mean change from baseline in patient global assessment of disease via visual analog scale(0-100 mm)
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
Trial Locations
- Locations (2)
Gupta Homoeo Clinic
🇮🇳Delhi, India
Kochhar Clinic
🇮🇳Ludhiana, Punjab, India