Health Condition 1: G431- Migraine with aura Health Condition 2: G430- Migraine without aura
Conditions
Interventions
Intervention1: Brahma Rasayana: Dose :6gm twice daily,
Dosage form:Lehyam,
Route of Administration:Oral,
Time of Administration:7.30 am before breakfast&7.30pm before dinner,
Anupana:Potable Water, Qu
Sponsors
Central Council For Research In Ayurvedic Sciences
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children of either sex aged in between 6 to 13 years. 2.Children who meet ICD-10 criteria for mild mental retardation. 3.Willing and able to participate for 6 months (consent to be obtained from Parent(s) / Guardian(s)). 4.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.Patientââ?¬•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 corticosteroids 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 / VSMS canââ?¬•t be administered for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in BKT or VSMS Abnormal behavioral test and Parental Perception EvaluationTimepoint: BKT or VSMS at Base Line, at the end of 3 months and at the end of 6 months ABT at Base line, at the end of 1,2 ,3 ,4 ,5 and 6months Parental perception at the end of 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptomatic ImprovementTimepoint: At the end of 1,2,3,4,5 and 6 months | — |
Countries
India
Contacts
Public ContactDr D Sudhakar
Central Council for Research in Ayurvedic Sciences
Outcome results
None listed