Randomised open-label clinical study on the efficacy of vardhamana nagabala rasayana in comparison with samvardhana ghrita on neuromuscular activity in children with cerebral palsy.
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
研究概览
简要总结
Cerebral palsy is a non-progressive neurodevelopmental disorder characterized by impairment of movement, posture, and neuromuscular activity due to insult to the developing brain. Children with cerebral palsy commonly present with abnormal muscle tone, delayed motor development, and functional limitations, significantly affecting daily activities and quality of life.
In Ayurveda, such congenital neuromuscular conditions are described under Murdhnabhighata Janya Vata Vyadhi, predominantly involving Vata Dosha vitiation. Rasayana therapy is indicated to enhance strength, nourishment, and functional development of the neuromuscular system.
The present study is a randomised, open-labelled, comparative clinical trial conducted to evaluate the efficacy of Vardhamana Nagabala Rasayana and Samvardhana Ghrita on neuromuscular activity in children with cerebral palsy.
Eligible children fulfilling the inclusion criteria will be randomly allocated into two groups. Group A will receive Vardhamana Nagabala Rasayana for 19 days, and Group B will receive Samvardhana Ghrita for 30 days. The selected interventions possess Balya, Medhya, and Vata-shamaka properties, which may help in improving neuromuscular function.
Clinical assessment will be carried out before and after intervention using standardized paediatric neuromuscular and motor function assessment scales. The outcomes of both groups will be statistically analysed and compared to assess improvement in neuromuscular activity and functional performance.
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
- 3.00 Year(s) 至 7.00 Year(s)（—）
- 性别
- All
入选标准
- •Participants between the age group of 3 years to 7 years.
- •Participants diagnosed with cerebral palsy as per ICD 11 criteria
- •Participants diagnosed with spastic hemiplegia, diplegia, dyskinetic, ataxic cerebral palsy.
- •Participants whose parents or legal guardians are willing to sign the written informed consent form.
- •Participants who have been already diagnosed with cerebral palsy and are on supportive treatments like physiotherapy, ADL (activities of daily living) training will be included.
排除标准
- •Children of CP with major congenital anomalies
- •Children who are currently on medications like baclofen, diazepam, tizanidine.
- •Children with Cerebral palsy associated with other illness like respiratory complications, orthopedic complications, contractures, severe neuromuscular conditions.
- •Children diagnosed with spastic quadriplegia.
研究者
Dr Monika Singh Chauhan
Sri Sri College of Ayurvedic science and Research