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A clinical study to see the effect of some Ayurvedic formulations in mentally challenged children.

Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficit - ACT- CD-2010

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/01/002376
Enrollment
150
Registered
2012-01-25
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Cognitive Deficit

Interventions

Intervention1: Brahmi Ghrita: Dose â?? 10 gm twice daily Dosage form - Ghrita Route of Administration â?? Oral Time of Administration-Twice a day before food Anupana-Lukewarm Water Packing form- 300

Sponsors

Department of AYUSH Ministry of Health Family Welfare Government of India
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Children of either sex aged between 8 to 13 years 2. Children with Intelligence Quotient 70 - 84 (Weschlerâ??s-IQ Indian adaptation by Malin) 3. Willing and able to participate for 16 weeks. (Assent to be obtained from Parent(s) / Guardian(s)).

Exclusion criteria

Exclusion criteria: 1. Children suffering from major systemic illness necessitating long term drug treatment. 2. Children with evidence of malignancy. 3. Children with concurrent serious Hepatic Dysfunction (defined as AST and/or ALT > 3 times of the upper normal limit) or Renal Dysfunction (defined as S. creatinine > 1.2mg/dl) Uncontrolled Pulmonary Dysfunction (asthmatic and COPD patients) 4. H/o hypersensitivity to any of the trial drug or their ingredients 5. Children who have completed participation in any other clinical trial during the past six (06) months. 6. Any other condition which the P.I. thinks may jeopardize the study.

Design outcomes

Primary

MeasureTime frame
â?¢ Symptomatic Improvement.Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Secondary

MeasureTime frame
â?¢ Change in Modified Child Mini Mental Scale Examination (MMMSE).Timepoint: At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Countries

India

Contacts

Public ContactDr Pradeep Dua

Central Council for Research in Ayurvedic Sciences (CCRAS)

duadrpradeep@gmail.com011-28525831

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026