Clinical Evaluation of Rasnadi Ghrita and Yog Basti in Spastic Cerebral Palsy in Children: A Single Arm Open Label Study
试验速览
- 阶段
- Phase 3 4
- 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
| Number of Groups |
One
|Sample Size
30 children diagnosed with spastic cerebral palsy
|Purpose
Evaluate efficacy and safety of Rasnadi Ghrita and Yog Basti
|Purva Karma (Pre-procedure)
Deepan and pachan will be done as required
Duration: 5 days Bahya Snehana: Sarvanga Abhyanga (25–30 min)Swedana: Sarvanga Swedana (10–15 min)
|Trial Drugs
Oral Medicine: Rasnadi Ghrita Anuvasana Basti: Shuddha Bala Taila Niruha Basti: Siddha Basti
|Dosage
Rasnadi Ghrita: 2 divided doses for 16 days (3.6–27.4 g depending on age, 1–16 yrs)
Anuvasana/Niruha Basti: Classical schedule
|Anupana (Vehicle)
Luke warm milk for oral Rasnadi Ghrita
|Route of Administration
Rasnadi Ghrita: Oral ,Yog Basti: Per Rectum
|Duration of Study
96 days (32-day active trial + 64-day follow-up / Parihar Kal)
|Monitoring
Weekly during the active trial phase
|Follow-up
Day 32 (end of trial), Day 96 (end of follow-up)
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
- 1.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •Children aged 1 to 16 years of both sexes Clinical diagnosis of spastic cerebral palsy based on characteristic signs and symptoms Mild to moderate intellectual disability associated with cerebral palsy Parents or guardians willing to participate and commit to study follow up for at least 3 months.
排除标准
- •Children aged below 1 year or above 16 years Presence of chronic systemic diseases such as Hridroga Prameha Vrikka Yakrit Vikara or any other congenital disease Children with progressive neurological disorders Severe physical disability that limits participation Other types of cerebral palsy such as dyskinetic extrapyramidal or mixed forms Quadriplegic cerebral palsy with status epilepticus History of recent orthopedic surgery casting splinting or fixed contractures Caregivers unwilling to provide informed consent.
研究者
Dr Namita Gundu Pawar
Post Graduate Institute of Ayurveda