Clinical evaluation of Sa-lavana Upnaha Swedana and Shastikshali Pind Sweda on spasticity in Cerebral palsy.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in spasticity in children with cerebral palsy measured by Modified Ashworth Scale.
研究概览
简要总结
Cerebral palsy (CP) is a non-progressive neuromotor disorder of posture and movement, with spasticity being the most common presentation. Current modern therapies for spasticity have limitations and side effects. Ayurveda mentions Shastikshali Pind Sweda and Sa-lavana Upnaha Swedana as effective modalities in Vata Vyadhi.
This randomized comparative clinical trial will include 60 children (1–16 years) with spastic CP, divided into two groups: Group A – Shastikshali Pind Sweda alone, and Group B – Shastikshali Pind Sweda with Sa-lavana Upnaha Swedana. Intervention will be given once daily before breakfast for 14 days.
The primary outcome will be reduction in spasticity assessed by the Modified Ashworth Scale (MAS) at Day 1 and day 14. Secondary outcomes include improvement in range of movement, functional abilities, and safety outcomes.
The study aims to evaluate whether Sa-lavana Upnaha provides additional benefit over Shastikshali Pind Sweda in reducing spasticity in cerebral palsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients in all sex in age group between 01yrs to 16yrs.
- •Children who have not received any form of modern intervention for spasticity at least for last 3 months.
- •Patients fulfilling the diagnostic criteria will be included for the study.
- •Patient fit for Shastikshali Pind Sweda and Sa-lavana Upnaha.
排除标准
- •Patients with non-spastic Cerebral Palsy.
- •Patients with any known major congenital anomalies like congenital heart disease (CHD) etc.
- •Patients with other disease states like Acute infections, Severe systemic illness and children with any Progressive neurologic anomalies.
- •Children with any other disease like Epilepsy or receiving any other drugs that may interfere with the study outcome.
- •At the time of enrolment, if the child is found to be non-inclusive due to underlying health condition or medication and thus not suitable for treatment will be excluded.
结局指标
主要结局
Change in spasticity in children with cerebral palsy measured by Modified Ashworth Scale.
时间窗: Day 1 | Day 14
次要结局
- Improvement in range of motion and Functional abilities in affected part.(Day 1)
研究者
Dr Prajjwal baranwal
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan