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Clinical Trials/CTRI/2025/08/092890
CTRI/2025/08/092890Not yet recruitingPhase 3 4

Effect of Brahmi Ghrita and Saraswata Churna in Children with Attention Deficit Hyperactivity Disorder aged 6-12 years

Dr Pooja Rose CJ1 site in 1 country21 target enrollmentStarted: October 1, 2025Last updated:

Trial Snapshot

Phase
Phase 3 4
Status
Not yet recruiting
Sponsor
Enrollment
21
Locations
1
Primary Endpoint
Changes in features of Attention Deficit Hyperactivity Disorder assessed using the ADHDT-2 scale

Study Overview

Brief Summary

Children with an age group of 6- 12 years satisfying the DSM 5 criteria for ADHD will be selected for the study from the OPD of Government Ayurveda College Hospital for Women and Children, Poojappura, Informed consent will be taken from the parents of the selected participants. The participants in the study group will be made fit to take the ghrita yoga after administering ashtachurna [age-appropriate dose] having Deepana-pachana property for the correction of Agni, for a period of 5 days. Then the participants will be administered with Brahmi Ghritain age-appropriate dose twice daily with lukewarm water as anupana before foodandSaraswata Churnain age-appropriate dose twice daily with honey as anupana after fooddepending upon the age of the child. They will be advised on dietary regulations for ADHD. Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS). Trial drug will be given for sixty days. Further, the data will be collected, scored, and statistically analyzed using appropriate statistical techniques.

Study Design

Study Type
Interventional
Allocation
Na
Masking
None

Eligibility Criteria

Ages
6.00 Year(s) to 12.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Children diagnosed with Attention Deficit Hyperactivity Disorder of the age group of 6 to 12 years according to DSM-5 criteria.

Exclusion Criteria

  • Presence of any other psychiatric comorbidity.
  • Presence of any other organic problem or brain damage iii.
  • Diagnosed cases of mental retardation iv.
  • Patients with other diagnosed genetic disorders.

Outcomes

Primary Outcomes

Changes in features of Attention Deficit Hyperactivity Disorder assessed using the ADHDT-2 scale

Time Frame: Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS).

and Vanderbilt ADHD Diagnostic Parent Rating Scale (VADPRS).

Time Frame: Assessment of ADHD features before and after study and after follow- up will be done by using the ADHDT-2 scale and the Vanderbilt ADHD diagnostic parent rating scale (VADPRS).

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Dr Pooja Rose CJ
Sponsor Class
Other [Govt. Ayurveda College Thiruvananthapuram]
Responsible Party
Principal Investigator
Principal Investigator

Dr Pooja Rose CJ

Govt. Ayurveda College Thiruvananthapuram

Study Sites (1)

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