Health Condition 1: null- COGNITIVE DEFICIT
Conditions
Interventions
Intervention1: SARASWATA GHRITA: Dose 6 gms.
Dosageform: Ghrita (Ghee)
Route of Administration : Oral
Time of Administration: Twice a day
before food.
Packing form:400 gms. pet jar
Anupana :Ushnodaka(Warm water)
Duration of therapy: 3 months
Control Intervention1: NOT APPLICABLE: NOT APPLICABLE
Sponsors
Central Council for Research in Ayurvedic Sciences 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 severe infection and/or clinically significant hepatic, respiratory, renal, cardiac or hematological disorders. 2. 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. 3. Patientâ??s guardian who cannot be relied upon to comply with the test procedures or are unwilling to give informed consent. 4. The Children had any intramuscular, intra-articular or intravenous carticosteroids within 4 weeks prior to study entry. 5. The Children with a history of recent and clinically significant drug abuse. 6. The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc. 7. The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study. 8. Children in whom another investigational drug was used within 3 months prior to entry in this study. 9. Children with poorly controlled epilepsy (H/o attack in last 3 months). 10. Children with a history of head injury. 11. Children to whom BKT canâ??t be administered for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in BKTTimepoint: Changes in BKT AT THE TIME OF RECRUITMENT AND AT THE END THE STUDY PERIOD THAT IS AFTER 90 DAYS WILL BE ASSESSED. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in Modified Child Mini Mental Scale Examination MMSE Abnormal behavioral test Parental Perception Evaluation Timepoint: MMSE AND ABC AT BASELINE AND AT THE END OF 30 60 90 DAYS PARENTAL PERCEPTION EVALUATION AT THE END OF 90 DAYS | — |
Countries
India
Contacts
Public ContactDR D SUDHAKAR
ACAMHNS
Outcome results
None listed