An open clinical trial of Siddha drugs “Akkini chooranam†(internal) and “Veera mezhugu†(external) in the treatment of “Kuthikaal vaatham†(Plantar fasciitis)
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Primary outcome of the study is pain relieving and it will be assessed by Universal Pain assessment scale (before and after treatment). Restricted movement assessment scale (before and after treatment) and Questionnaire.
研究概览
简要总结
It is a single, non-randomized, open-label trial to determine the efficacy and safety of AKKINI CHOORANAM in patients with KUTHIKAAL VATHAM (PLANTAR FASCIITIS). In this trial 40 patients will be recruited and the trial drug will be administered 1.5 gm twice a day for a period of 48 days. During this trial period all the study related data will be recorded and documented in a page separate trial master file for each patients.During the trial period if any AE/SAE/SUSAR will be noticed and referred to pharmacovigilance dept.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 the safety and 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 Indian 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
- •1.Pain and tenderness in the sole of the foot while on walking and standing.
排除标准
- •1.H/o Cardiac diseases 2.H/o Diabetes mellitus 3.H/o Rheumatoid arthritis 4.H/o Chronic kidney disease 5.Pregnancy and lactation 6.Septic arthritis 7.Gonococcal arthritis 8.Psoriatic arthritis 9.Patient with any other serious systemic illness.
结局指标
主要结局
Primary outcome of the study is pain relieving and it will be assessed by Universal Pain assessment scale (before and after treatment). Restricted movement assessment scale (before and after treatment) and Questionnaire.
时间窗: 48 days
次要结局
- Reduction in Associated factors of Kuthikaal vaatham by Age, Sex, BMI and occupation.(NIL)