A clinical trial to study the effects of a drug named Brahma Rasayan in Patients with Manasamanadata (Mental Retardation)
- Conditions
- Health Condition 1: G431- Migraine with auraHealth Condition 2: G430- Migraine without aura
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 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 canâ??t be administered for any reason
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes in BKT or VSMS <br/ ><br>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 <br/ ><br>ABT at Base line, at the end of 1,2 ,3 ,4 ,5 and 6months <br/ ><br>Parental perception at the end of 6 months
- Secondary Outcome Measures
Name Time Method Symptomatic ImprovementTimepoint: At the end of 1,2,3,4,5 and 6 months