Folinic acid for autism
Phase 2
- Conditions
- Health Condition 1: F840- Autistic disorder
- Registration Number
- CTRI/2021/07/034901
- Lead Sponsor
- Indian Council of Medical Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Satisfying DSM V criteria for autism
2. Unchanged antipsychotic medication, complementary, traditional, behavioral and education therapy 8 weeks prior to enrollment
3. Intention to maintain ongoing therapies constant throughout the trial
Exclusion Criteria
1. Uncontrolled gastroesophageal reflux
2. History of liver or kidney disease;
3. Receiving drugs known to affect folate metabolism
4.Well-defined genetic syndromes or genetic mutations known to significantly affect folate-associated pathways;
5. A clinical seizure within the last 6 months
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in Childhood Autism Rating Scale (CARS)Timepoint: At 0 week and after 24 weeks
- Secondary Outcome Measures
Name Time Method Childhood Sleep Habits QuestionnaireTimepoint: At 0 weeks and after 24 weeks