Preclinical and clinical study of siddha drugs Vaatha chooranam (internal) and Vaatha mega narayana ennai (external) in the treatment of Vali Azhal keel vayu(Rheumatoid Arthritis)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Rheumatoid arthritis is diagnosed by European League against rheumatism (EULAR)and prognosis is assessed by modified health assessment questionnaire (MHAQ)
研究概览
简要总结
It is a single non randomized, open label trial to determine the efficacy of Muddakku vatha choornam (prepared from herbal constituents) in patients with Vali azhal keel vayu (Rheumatoid arthritis). In this trial 40 patients will be recruited and the trial drug will be administered 2 gm twice a day with honey for a period of 48 days. During the trial period if any AE/SAE/SUSAR will be noticed and reffered to pharmacovigilance department in NIS and further management will also be given in NIS OPD/IPD. The entire trial will be monitored by the research monitoring committee of NIS. During this trial all safety efficacy parameters will be recorded in the CRF. After completion of the trial all the study related data will be analysed statistically. The out come of this trial will be published in India Journal of Medical Research.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Age: 20- 60 years 2)Sex: Both male and female 3)Any of the following three symptoms Pain and swelling in three or more joint Morning Stiffness Rheumatoid factor positive Deformities like Swan neck and Buttton hole deformity Rheumatoid nodules 4)Symmetrical joints involvement 5)patient willing to undergo laboratory Investigation 6)Patient willing to sign the informed consent.
排除标准
- •Pregnancy and lactation 2)Tubercular arthritis 3)Gouty arthritis 4)Diabetic Mellitus 5) Malignant Hypertension 6)Any other systemic illness.
结局指标
主要结局
Rheumatoid arthritis is diagnosed by European League against rheumatism (EULAR)and prognosis is assessed by modified health assessment questionnaire (MHAQ)
时间窗: 48 days
Reduction of pain is assessed before and after treatment by Universal pain assessment scale using Questionnaire
时间窗: 48 days
Improvement in restriction of movements is assessed by restricted movements assessment scale
时间窗: 48 days
次要结局
- 1)Safety study of drugs Muddakku vatha choornam(2)Analytical study of drug muddakku vatha choornam)