CTRI/2011/04/001701招募中2 期
EFFECT OF AYURVEDIC CODED DRUG (AYUSH MANAS) IN THE MANAGEMENT OF MANASA MANDATA (MENTAL RETARDATION) - None
Central Council for Research in Ayurveda and Siddha CCRAS0 个研究点目标入组 120 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Children of either sex aged in between 6 to 13 years
- •2.Children with mild to moderate Mental Retardation
排除标准
- •1.Children with a history of peptic ulcer disease, any gastric or duodenal surgery, gasterointestinal (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 2times uppr limit of normal; serum bilirubin or Alkaline phosphatase 1.5 times upper limit of normal.
- •4.Subject?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 has likelihood of requiring treatment during the study period with drugs not permitted by the study protocol.
- •7.The Children with a history of recent and clinically significant drug abuse.
- •8.The Children with pre-existing blood dyscrasias, eg., bone marrow hypoplasia, leukopenia, thrombocytopenia etc.
- •9.The Children is unlikely to comply with protocol, eg., un cooperative attitude, inability to return for follow-up visits, and unlikelihood of complete study.
- •10.Children in whom another investigational drug was used with in 3 months prior to entry in this study.
- •11.Children with poorly contolled epilepsy (H/o attack in last 3 months).
- •12.Children to whom Binet Kamat Test (BKT) can?t be administered for any reason such as speech delay, severe hyperkinesis etc.
- •13.The use of cognitive enhancers such as piracetam etc or if the child will require antidepressant, anti-anxiety, anti ?psychotic drugs during the study.
研究者
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