CLINICAL EVALUATION OF BRAHMI GHRITA MATRA BASTI AND BRAHMI GHRITA ORALLY IN AUTISM
概览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Assess improvement in core symptoms of ASD using CARS.
概览
简要总结
Autism Spectrum Disorder (ASD) is a neurodevelopmental disorder with impaired communication, restricted interests, and repetitive behaviors. Current medicines only manage associated symptoms and have side effects. Ayurveda describes a similar condition under Unmada. Brahmi Ghrita is a classical Medhya Rasayana useful for cognition, memory, and speech, while Matra Basti is beneficial in Vata Vyadhi.
This randomized comparative clinical study will evaluate oral Brahmi Ghrita versus Brahmi Ghrita Matra Basti with oral administration in 60 children (3–12 years) diagnosed with ASD as per DSM-V criteria. Group A will receive oral Brahmi Ghrita for 30 days; Group B will receive Matra Basti for 7 days followed by oral administration for 23 days.
Efficacy will be assessed using the Childhood Autism Rating Scale (CARS) and Aberrant Behavior Checklist (ABC). The study aims to establish a safe, cost-effective Ayurvedic intervention for Autism Spectrum Disorder.
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 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Diagnosed cases of Autism satisfying DSM V Criteria.
- •2.Children from 3 to 12 years, irrespective of gender, religion.
- •3.Parents / guardian willing to give informed written consent to participate in the study.
排除标准
- •i.Patients having mental retardation, cerebral palsy, seizures, epilepsy.
- •ii.Patients having presence of other organic or psychotic neurological disorder.
- •iii.Patients having hearing and visual impairment.
- •Patients having acute and chronic systemic illness such as renal diseases, hepatic dysfunction, juvenile diabetes mellitus etc.
- •Patients having any other congenital disorders.
结局指标
主要结局
1. Assess improvement in core symptoms of ASD using CARS.
时间窗: 1. DAY 7 OF TREATMENT | 2. DAY 15 OF TREATMENT | 3. DAY 30 OF TREATMENT | 4. DAY 45 AFTER TREATMENT
2. Assess behavioral improvement using ABC.
时间窗: 1. DAY 7 OF TREATMENT | 2. DAY 15 OF TREATMENT | 3. DAY 30 OF TREATMENT | 4. DAY 45 AFTER TREATMENT
3. Compare oral Brahmi Ghrita with Brahmi Ghrita Matra Basti plus oral administration.
时间窗: 1. DAY 7 OF TREATMENT | 2. DAY 15 OF TREATMENT | 3. DAY 30 OF TREATMENT | 4. DAY 45 AFTER TREATMENT
次要结局
- A BETTER MANAGEMENT OUTCOMES IN AUTISM THROUGH BIOLOGICAL METHODS(15 DAYS)
研究者
MONIKA
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan