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

Phase 2

Recruiting

• Conditions: Cognitive Deficit

• Registration Number: CTRI/2012/01/002376
• Lead Sponsor: Department of AYUSH Ministry of Health Family Welfare Government of India

Brief Summary

Aimed at scientific validation of the clinical efficacy and safety of twenty nine (29) classical Ayurvedic pharmacopoeial formulations, multicentre clinical trials have been initiated as an activity under the Ayurveda Clinical Trials (ACT) project of the Ayurvedic Pharmacopoeia Committee (APC) during August 2010 in eighteen (18) disease conditions involving fifty four (54) M.D/PhD (Ay.) research scholars in eight (08) postgraduate Ayurveda colleges across the country.

**Brahmi Ghrita** is a poly herbal formulation containing Brahmi (Bacopa monnieri), Sunthi (Zingiber officinale), Marica (Piper nigrum), Pippali (Piper longum), Trivrta (Operculina turpethum), Danti (Baliospermum montanum), Shankhapushpi (Convolvulus pluricaulis), Aragvadha (Cassia fistula), Saptala (Euphorbia dracunculoides) and Vidanga (Embelia ribes).

**Jyotismati Taila** is oil obtained from a plant named Jyotishmati (Celastrus paniculatus).

The present study is being undertaken in three post graduate Ayurveda colleges to scientifically study and validate the clinical efficacy and safety of **Brahmi Ghrita and Jyotishmati Taila**- classical Ayurvedic formulations which have been in use since ages and found effective in treating Cognitive Deficit and promoting the health.

The **Central Council for Research in Ayurvedic Sciences (CCRAS)** is the nodal organization to co-ordinate and monitor these trials. CCRAS has provided the necessary infrastructure to the participating colleges, technical inputs (including the clinical trial protocols), trial drugs and training to the researchers involved in the project.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12-17

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• 1. Children of either sex aged between 8 to 13 years 2. Children with Intelligence Quotient 70.
• 84 (Weschler’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

• Children suffering from major systemic illness necessitating long term drug treatment.
• Children with evidence of malignancy.
• 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.
• Any other condition which the P.I. thinks may jeopardize the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
• Symptomatic Improvement.	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 Outcome Measures

Name	Time	Method
• Change in Modified Child Mini Mental Scale Examination (MMMSE).	At Baseline, 14th day-28th day-42nd day-56th day-70th day-84th day and at the end of follow up after 16th week.

Trial Locations

Locations (3)

National Institute of Ayurveda (NIA), Jaipur; 🇮🇳 Jaipur, RAJASTHAN, India

Tilak Ayurved Mahavidyalaya, Pune; 🇮🇳 Pune, MAHARASHTRA, India

Vaidyaratnam P. S. Varier Ayurved College, Kottakkal; 🇮🇳 Malappuram, KERALA, India

National Institute of Ayurveda (NIA), Jaipur

🇮🇳Jaipur, RAJASTHAN, India

Prof Abhimanyu Kumar Dr Arun Parameshwar Kute

Principal investigator

9414779931

ak_ayu@yahoo.co.in