CTRI/2024/01/060989Not yet recruitingPhase 3
A Randomized Controlled Trial to Evaluate the Effect of Daily Abhyanga with Balaswagandha Lakshadi Taila in Response inhibition Among Children with Hyperactivity.
Dr Arathi M Nair1 site in 1 country24 target enrollmentStarted: January 8, 2024Last updated:
Trial Snapshot
- Phase
- Phase 3
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- •Response inhibition.
Study Overview
Brief Summary
The study is a Randomized Controlled Trial to evaluate the effect of Balaswagandha Lakshadi taila over Behaviour modification in Response Inhibition among children with Hyperactivity aged 7-12 years. Participants who meet the criteria for hyperactivity (who has a score above 15), as determined by the Conner’s Abbreviated Teacher rating scale will be separated into two group using simple random sampling technique. One group provided with behavioural modification and the other group with Abhyanga along with behavioural modification.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Masking
- None
Eligibility Criteria
- Ages
- 7.00 Year(s) to 12.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Screened for hyperactivity using Conner Abbreviated Teacher Rating scale and selected subjects who has a score above 15 Consent from Parents / Guardian.
Exclusion Criteria
- •Children who are under medication for epilepsy.
- •Children who have asthma and experience repeated or frequent episodes of asthma attacks.
- •Children with skin disorders.
Outcomes
Primary Outcomes
•Response inhibition.
Time Frame: • At baseline, 3 months
Secondary Outcomes
- Hyperactivity(at baseline, 3 months)
Investigators
Dr Arathi M Nair
Amrita School of Ayurveda
Study Sites (1)
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