Clinical Evaluation of Brahma Rasayana in the Management of â??Manasamandata (Mental Retardation)â?? â?? an open clinical trial. - Manasa Mandata (MR)

Central Council For Research In Ayurvedic Sciences0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•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

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