A clinical trial to study the effect of Ayurveda therapies with oral administration of Swarnaprashana on Autism spectrum disorder in children aged 3-12 years
Phase 2
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2023/06/053937
- Lead Sponsor
- Dr vanaja s
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Children aged between 3-12 yrs present with manifestation of autism spectrum disorder
2. Children of either gender fulfilling the DSM-5 criteria and who pass M-chat.
3. Parents who voluntarily agree to participate their child in the study and ensure strict adherence the same will be include in the study
Exclusion Criteria
1. Children with epileptic syndrome and language regression
2. Children with ASD along with underlying structural abnormalities (tuberous sclerosis, primary epileptic abnormality)
3. Children with uncontrolled seizures
4. Children with whose parents are not willing to participate
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Behavior manifestation social relationship & reciprocity emotional response impairment in cognition speech & communication will be observed & assessed using Indian scale for the assessment of Autism <br/ ><br>Childhood Autism rating scale CARS & Manobhava pareeksha symptomatic gradingTimepoint: ISAA Assessment on 0 day <br/ ><br>30 day <br/ ><br>60 day <br/ ><br>90 day <br/ ><br>CARS & Manobhava pareeksha symptomatic grading on 0 day & 90 days <br/ ><br> <br/ ><br>
- Secondary Outcome Measures
Name Time Method Changes in gut manifestation by subjective symptomatic gradingTimepoint: On 0 day, 30th day 60th day, 90th day & on 120 th day