An open labelled triple arm non randomized phase II clinical trial,To Compare the Effectiveness of Varma Adangal murai and Athimathura chooranam (Internal) and Ulunthumaa poochu (External) in the Management of Kuthikaal vatham
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Reduction of pain and improvement the movement of the affected ankle after
研究概览
简要总结
It is an open labelled triple arm non randomized phase II clinical trial to compare the effectiveness of varma adangal murai and Athimathura chooranam (internal) and Ulunthumaa Poochu (external) in the management of Kuthikaal vatham.
The dosage of internal medication Athimathura Chooranam is 1 gram (BD) and will be administered after food for 48 days.
The external application of Ulunthumaa Poochu will be topically applied for 48 days.
The manipulation of Varma Adangal murai will be done continuously for first one week and thrice a week for 8-21 days.
The sample size for the study is 60 which will be categorized in to 3 groups of each 20.
The first group will be given with Varma Adangal murai only.
The second group will be given with internal medication along external application.
The third group will be given with Varma Adangal murai,internal medication and external application.
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
- 25.00 Year(s) 至 68.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Talalgia 2.Arthritis 3.Bruising of Heel 4.Walking gait issues 5.Patient who are willing for admission and stay in IPD or Willing to attend OPD 6.Patient willing to sign the informed consent.
排除标准
- •1.Age Below 24 years and above 69 years 2.Fracture of the foot 3.Rupture of Achilles Tendon 4.Patient with any other serious systemic and chronic illness.
结局指标
主要结局
Reduction of pain and improvement the movement of the affected ankle after
时间窗: 48 days
the treatment with trial drugs will be assessed by VAS Score
时间窗: 48 days
次要结局
未报告次要终点
研究者
Dr THENMOZHI S
Government Siddha Medical College and Hospital Palayamkottai