Health Condition 1: null- mental retardation
Conditions
Interventions
Intervention1: "Ayush Manas": 2 tablets of 250mg/tab of "Ayush manas" once daily in the morning for one year.
?Ayush Manas? is a proprietary Ayurvedic formulation developed by Central Council for Rese
Sponsors
Central Council for Research in Ayurveda and Siddha CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children of either sex aged in between 6 to 13 years 2.Children with mild to moderate Mental Retardation
Exclusion criteria
Exclusion criteria: 1.Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gasterointestinal (GI) bleeding or other GI disorders. 2.Children with severe infection and/or clinically significant hepatic, respiratory, renal, cardiac or hematological disorders. 3.Children with abnormal laboratory values at admission in to the study: serum creatinine 1.2 mg/dl, SGOT, SGPT 2times uppr limit of normal; serum bilirubin or Alkaline phosphatase 1.5 times upper limit of normal. 4.Subject?s guardian who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent. 5.The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4 weeks prior to study entry. 6.The Children has likelihood of requiring treatment during the study period with drugs not permitted by the study protocol. 7.The Children with a history of recent and clinically significant drug abuse. 8.The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc. 9.The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study. 10.Children in whom another investigational drug was used with in 3 months prior to entry in this study. 11.Children with poorly contolled epilepsy (H/o attack in last 3 months). 12.Children to whom Binet Kamat Test (BKT) can?t be administered for any reason such as speech delay, severe hyperkinesis etc. 13.The use of cognitive enhancers such as piracetam etc or if the child will require antidepressant, anti-anxiety, anti ?psychotic drugs during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| (1) CHANGE in IQ as measured by Binet-Kamat Test in the active treatment group compared to placebo group at the end of 1 year of treatment and (2) CHANGE in Social Quotient as measured by Vineland Social Maturity Scale at the end of 6 months and 1 yearTimepoint: (1) CHANGE in IQ as measured by Binet-Kamat Test in the active treatment group compared to placebo group at the end of 1 year of treatment and (2) CHANGE in Social Quotient as measured by Vineland Social Maturity Scale at the end of 6 months and 1 year | — |
Secondary
| Measure | Time frame |
|---|---|
| (1) Change in problem behaviors as measured by Maladaptive Behavior Scale (Part II of ABS of AAMR) at the end of 1 year, and (2) Parental perception evaluation of efficacy of medication at the end of 1 yearTimepoint: At the end year of treatment | — |
Countries
India
Contacts
Public ContactDr Satish Chandra Girimaji
Dept of Child and Adolescent Psychiatry
Outcome results
None listed