Health Condition 1: F70- Mild intellectual disabilities
Conditions
Interventions
Intervention1: Group 1: Group I:
1. AYUSHMANAS(Coded drug)
Dose : 250mg x 2 tab b i d
Form of Administration : Tablet
Route of Administration : Oral
Time of Administration : Twice a dayafte
Sponsors
CCRAS MINISTRY OF AYUSH
Eligibility
Inclusion criteria
Inclusion criteria: 1. Children of either sex aged in between 8 to 13 years. 2. Children with Intelligence Quotient 63 â?? 80 as per BKT 3. Willing and able to participate for 6 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 with in 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 AYUSHMANAS in the Management of Smriti Daurbalya.Timepoint: The outcome shall be assessed periodically every 30 days once till the completion of 6 months intervention period. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the clinical safety of AYUSHMANAS in the children suffering from Smriti Daurbalya.Timepoint: duration of study 3 years intervention period 6 months | — |
Countries
India
Contacts
Public ContactG V RAMANA
CCRAS MINISTRY OF AYUSH
Outcome results
None listed