To evaluate the safety and efficacy of Ayurvedic Interventions and Analysis of Gut Flora in the cases of Amavata vis-Ã -vis Rheumatoid Arthritis.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- IMPROVED DAS28 SCORE AND EULAR SCORE
研究概览
简要总结
**1.**To reflect an overview of the concept of Amavata vis-à -vis rheumatoid arthritis. Toreviewthe role of gut flora in the pathogenesis of rheumatoid arthritis andcharacterize the facultative aerobic bacteria’s in the gut flora in RA patientswith respect to control. To study the effect of Virecana Karma and Shatyadikashaya Ghana Vati on subjective and objectives parametersin the cases of rheumatoid arthritis. To compare the efficacyof VirecanaKarma and Shatyadi kashaya Ghana Vatiin the cases of rheumatoid arthritis. Tostudy the effect of Virecana Karma and drug over pro and anti-inflammatory markersat the baseline and at the end.
·
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients of age group between 30-50 yrs willing to participate for the trial with a diagnosis of rheumatoid arthritis using the ACR
- •2.Diagnosed cases of Amavata based on symptoms and signs described in Madhav Nidana.
- •3.Patients with H/O more than 1year with established disease.
- •4.Sero positive and Seronegative both cases are included.
排除标准
- •1.Patients not willing to participate.
- •2.Patients with a short history of less than a year.
- •3.Patients having severe deformities.
- •4.Patients of Rheumatic Arthritis, Gouty Arthritis, Infective Arthritis, Osteoarthritis.
- •5.HIV, Tuberculosis, Hypertension, D.M., and other systemic problems.
- •6.Pregnant & lactating women 7.Patients with major complications such as extra-articular manifestations are also excluded.
结局指标
主要结局
IMPROVED DAS28 SCORE AND EULAR SCORE
时间窗: AT THE TIME OF REGISTRATION, AT THE TIME OF 1ST FOLLOW-UP AT 30DAYS, AT 2ND FU AT 60DAYS, AT 3RD FU AT 90DAYS.
次要结局
- ANTI CCP, IL 17, IL10(AT THE TIME OF REGISTRATION AND AT THE COMPLETION OF TRIAL)