Health Condition 1: null- children between 8 to 13 yearswith Intelligence Quotient 63 to 80 as per Binet Kamat Test (BKT) Health Condition 2: F70- Mild intellectual disabilities
Conditions
Interventions
Intervention1: kalyanaka ghritham: Children identified to be in dull normal intelligence quotient will be administered with kalyanaka ghritham in 6gm dosage twice daily till 3 months duration. monthly
Sponsors
CCRAS
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either sex aged in between 8 to 13 years. 2. Children with Intelligence Quotient 63 - 80 as per Binet Kamat Test (BKT). 3. Willing and able to participate for 3 months (consent to be obtained from Parent(s) / Guardian(s)/ Assent from children wherever possible).
Exclusion criteria
Exclusion criteria: 1. Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gastrointestinal (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 >3times upper limit of normal; serum Bilirubin or Alkaline phosphatase >1.5 times upper limit of normal. 4. Patientâ??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 with a history of recent and clinically significant drug abuse. 7. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc. 8. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study. 9. Children in whom another investigational drug was used within 3 months prior to entry in this study. 10. Children with poorly controlled epilepsy (H/o attack in last 3 months). 11. Children to whom BKT canâ??t be administered for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the clinical efficacy of Kalyanaka Ghrita in the Management of Smriti Daurbalya.Timepoint: Follow up at 30 days and 60 days from base line and final assessment at 90 days | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical safety of Kalyanaka Ghrita in the children suffering from Smriti Daurbalya.Timepoint: At the completion of trial | — |
Countries
India
Contacts
Public ContactDr Ramana G V
CCRAS
Outcome results
None listed