To Study the Effect of Structured Integrative Medicine Lifestyle Approach as an Add-on Therapy on Symptom Severity and Mental Health Related Outcomes in Elderly with Restless Leg Syndrome- An Exploratory Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Restless leg syndrome symptom severity assessed using International Restless Legs Syndrome Study Group (IRLSSG) rating scale
研究概览
简要总结
This RCT aims to evaluate the effectiveness of a structured integrative medicine lifestyle approach, including ayurvedic therapies like abhyanga and yoga as an adjunct to standard treatment in elderly patients with restless leg syndrome. conducted at AIIMS Rishikesh the study will enrol 30 participants in each arm, diagnosed to have RLS using IRLSSG criteria. the primary objective is to assess the reduction in RLS symptom severity while secondary outcomes include improvements in sleep quality nd mental health. participants will be randomly assigned to either the intervention or control group. the study aims to provide insights into a cost effective, patient friendly alternative for managing RLS symptoms in the elderly population
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 60.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Geriatric patients (55 years and above) diagnosed with restless leg syndrome.
- •Patient diagnosed to have RLS through- International RLS Study Group (IRLSSG) diagnostic criteria)
- •Willingness to participate and provide informed consent.
排除标准
- 未提供
结局指标
主要结局
Restless leg syndrome symptom severity assessed using International Restless Legs Syndrome Study Group (IRLSSG) rating scale
时间窗: baseline, 1 month, 2 month, 3 month
次要结局
- 1. sleep quality through PSQI(2. mental health through GDS)
研究者
Pankhuri Saxena
ALL INDIA INSTITUTE OF MEDICAL SCIENCES