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 .
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
研究概览
简要总结
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.
详细描述
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 .
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
placebo
1/2 ml of dispensing alcohol administered orally at every 7 day for 5 month .
干预措施: placebo (Drug)
Rhustoxicodendron 30
1/2ml Rhustoxicodendron 30 is administered orally every 7 day for 5 month.
干预措施: Rhustoxicodendron 30 (Drug)
结局指标
主要结局
Number of subject With American College of Rheumatology (ACR) Criteria Improvement of at Least 20%, 50%, and 70% (ACR 20/50/70 Responders).
时间窗: 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
次要结局
- mean change from baseline in swollen joint.(6 weeks upto 24 week)
- mean change from baseline in tender joint count.(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 patient global assessment of disease .(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)
研究者
ravinder kochhar
principal investigator
Healthcare Homoeo Charitable Society