Homoeopathic Intervention in Reducing The Pain of Ligament Sprains - A Clinical Interventional Study
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
- To evaluate the changes in Total Pain Rating Index (T-PRI) of Short-form McGill Pain
研究概览
简要总结
This study is a clinical interventional study for the homoeopathic management of reducing pain of ligament sprains that will be conducted in outpatient and in-patient departments and peripheral centers and camps conducted by the National Homoeopathic Research Institute in Mental Health, Kottayam. The primary outcome measures will be to evaluate the changes in Total Pain Rating Index (T-PRI) of Short-form mcGill Pain Questionnaire (SF-MPQ). The secondary outcomes will be to evaluate the changes in Activity, Sleep, Mood and Stress of DVPRS supplemental questions of Defense and Veterans Pain Rating Scale 2.0 (DVPRS). As the study with the aforementioned domains is one of its kind, it aims to make the efforts to offer possibilities for future research in the effectiveness of Individualized Homoeopathic Medicines in management of ligament sprains in general
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
- 14.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age 14 – 40 years of all genders.
- •Patients of mild to moderate ligament sprains.
排除标准
- •Patients presenting with any fractures or dislocations.
- •Patients with total or complete tear of ligament in MRI (or USG when MRI is contraindicated) that requires immediate surgery.
- •Pregnant and lactating women.
- •Patients with known severe systemic illnesses such as uncontrolled diabetes, severe cardiac diseases and malignancies.
结局指标
主要结局
To evaluate the changes in Total Pain Rating Index (T-PRI) of Short-form McGill Pain
时间窗: Every month from baseline till the conclusion of | the study (6th month)
Questionnaire (SF-MPQ).
时间窗: Every month from baseline till the conclusion of | the study (6th month)
次要结局
- To evaluate the changes in Activity, Sleep, Mood and Stress of DVPRS(supplemental questions of Defense and Veterans Pain Rating Scale 2.0)
研究者
Dr V P Varshiny
National Homoeopathy Research Institute in Mental Health