A clinical study to see the effect of some Ayurvedic formulations in the management of Mental Retardation.
- Conditions
- Cognitive Deficit
- Registration Number
- CTRI/2012/03/002536
- Lead Sponsor
- Central Council for Research in Ayurvedic Sciences CCRAS
- Brief Summary
The Central Council for Research in Ayurvedic Sciences (CCRAS) is an autonomous body under the Department of AYUSH (Ayurveda, Yoga &Naturopathy, Unani, Siddha and Homeopathy), Ministry of Health & Family Welfare, Government of India. CCRAS is an apex body in India for the formulation, co-ordination, development and promotion of research on scientific lines in the Ayurveda system of medicine.
Aimed at generating evidence for the scientific validation of the clinical efficacy and safety of twenty five classical Ayurvedic formulations, multicentre clinical trials have been initiated in sixteen disease areas across nineteen peripheral institutes of the Council as an activity under the Intra Mural Clinical Research (IMR) program.
This initiative is basically a supplement to the similar venture being worked out as an activity under the Ayurveda Clinical Trials (A.C.T.) project of the Ayurvedic Pharmacopoeia Committee (APC) wherein, clinical trials on eighteen disease conditions are underway in eight post graduate Ayurveda colleges across the country.
**Brahmi Ghrita** is a poly herbal formulation containing Brahmi (Bacopa monnieri), Shunthi (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 entitled **“Clinical Evaluation of Brahmi Ghrita and Jyotishmati Taila in the Management of Cognitive Deficitâ€** is being undertaken in one of the peripheral institutes of CCRAS.
The cumulative evidence generated as an activity under the ACT project as well as IMR programme is expected to scientifically substantiate the claims regarding clinical efficacy and safety of these classical Ayurvedic formulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- All
- Target Recruitment
- 150
-
- Children with Intelligence Quotient 70.
- 84 (Weschler’s-IQ Indian adaptation by Malin) 2. Willing and able to participate for 16 weeks. (Assent to be obtained from Parent(s) / Guardian(s)).
- 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 14th 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 14th week
Trial Locations
- Locations (1)
Advanced Centre for Ayurveda in Mental Health and Neuro Sciences Ayurvedic Research Unit, Bengaluru
🇮🇳Bangalore, KARNATAKA, India
Advanced Centre for Ayurveda in Mental Health and Neuro Sciences Ayurvedic Research Unit, Bengaluru🇮🇳Bangalore, KARNATAKA, IndiaDr Srinivas SahuPrincipal investigator9448941203drsrinibashsahoo@yahoo.co.in