A clinical study to see the effect of some Ayurvedic formulations in mentally challenged children.
- Conditions
- Health Condition 1: null- Cognitive Deficit
- Registration Number
- CTRI/2012/01/002376
- Lead Sponsor
- Department of AYUSH Ministry of Health Family Welfare Government of India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Open to Recruitment
- Sex
- Not specified
- Target Recruitment
- 150
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)).
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.