A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Poora Maathirai in the management of Uthiravatha suronitham (Rheumatoid arthritis)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The outcome will be aimed at reducing the symptoms of Uthiravatha suronitham (Rheumatoid Arthiritis) and to determine the efficacy of Poora Maathirai
研究概览
简要总结
This is A Prospective, open labelled, single arm, non randomized, single centric, phase II, Clinical trail to determine the effectiveness of Poora Maathirai in the management of Uthiravatha suronitham (Rheumatoid arthiritis). After purification of trial drugs, Poora maathirai will be prepared and administered at the dosage of 1 to 2 tablets for 48 days for 40 Rheumatoid Arthritis patients ( 20 OP and 20 IP Patients). The primary outcome will be to evaluate the therapeutic effectiveness of Siddha herbal Poora Maathirai in the management of Uthiravatha suronitham(Rheumatoid arthritis).The secondary outcome will be to collect various Siddha literatures and modern journals for literature review of Uthiravatha suronitham, to perform physicochemical, phytochemical, bio chemical analysis of Poora Maathirai, to evaluate safety profile for acute and sub-acute toxicity of -Poora Maathirai, to evaluate pharmacological activities of Poora maathirai, to study other cofactors related to disease like age, sex, dietary habits, family history, and socioeconomic status, to study about the prevalence of Uthiravatha suronitham relation with diet and lifestyleto evaluate Siddha parameters (including Envagai thervu, Neerkuri-Neikuri) for Uthiravatha suronitham during trial period, to evaluate Dhegi of Uthiravatha suronitham patients, to evaluate modern parametric changes in Uthiravathasuronitham, to assess the quality of life of Uthiravatha suronitham patients, to document Bio statistical analysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)(—)
- 性别
- All
入选标准
- •1.Pain and early morning stiffness 2.Those who are willing to participate in this study 3.RA factor test – positive 4.Anti CCP – positive 5.CRP above 20 mg/L 6.ESR elevated 7.ANA TEST in few selected cases.
排除标准
- •1.Other degenerating joint diseases.
- •osteoarthritis, sero negative spondylo arthritis, ankylosing spondylitis 2.Infectious joint diseases like, Tuberculosis, chronic poly arthritis in chickungunia viral infection. 3.Metabolic joint diseases like gout. 4.Patient who is on DMARD. (eg: methotrexate) 5.Pregnancy and lactating mother. 6.Chronic renal & liver disease patients.
结局指标
主要结局
The outcome will be aimed at reducing the symptoms of Uthiravatha suronitham (Rheumatoid Arthiritis) and to determine the efficacy of Poora Maathirai
时间窗: 48 days
次要结局
- 1.To collect various Siddha literatures & modern journals for literature review on Uthiravatha suronitham.(2.To perform physicochemical, phytochemical, bio chemical analysis of Poora Maathirai.)
研究者
JANARTHANAN A
Government Siddha Medical College and Hospital palayamkottai
