Efficacy of Vijaya Ghrita in Comparison to Brahmi Ghrita on Specific Learning Disability in children- An Open Labelled Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Improvement in reading, writing and mathematical abilities in children suffering with
研究概览
简要总结
TITLE: EFFICACY OF VIJAYA GHRITA IN COMPARISON TO BRAHMI GHRITA ON SPECIFIC LEARNING DISABILITY IN CHILDREN- AN OPEN LABELLED RANDOMIZED CONTROLLED CLINICAL TRIAL.
PLAN OF STUDY: Minimum 32 children attending outpatient department and inpatient department of Kaumarabhritya of Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital (SDMIAH), Bengaluru who are fulfilling the inclusion criteria and willing to participate in the study under the parental assent or consent will be recruited for study for a period of 60 days. 32 children will be randomly divided into 2 groups namely Group A(16 children) and Group B (16 children). Group A (Study group) will be administered with Vijaya ghrita in a dose of 6g for 8-11 years and 10g for 12-15 years with hot water as anupana after food twice daily. Group B (Control group) will be administered with Brahmi ghrita in a dose of 6g for 8-11 years and 10g for 12-15 years with hot water as anupana after food twice daily. Assessment will be done using NIMHANS SLD battery by Clinical Psychologist. Statistical analysis will be done by considering the data of 0 (BT) and day 60 (AT) by using suitable test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 8.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Children with Specific Learning Disability belonging to the age group of 8 to 15 years with Intellectual quotient greater than 90, after getting consent from their parents.
排除标准
- •Children having speech and hearing defects Children having seizures Children having other systemic illness Children having mental retardation Children with Intellectual Quotient less than 90 Children with Autism and ADHD Children with emotional and conduct disorder.
结局指标
主要结局
Improvement in reading, writing and mathematical abilities in children suffering with
时间窗: 60 days
Specific learning disability using NIMHANS SLD battery.
时间窗: 60 days
次要结局
- Improvement in overall school performance of children suffering from Specific(Learning Disability using NIMHANS SLD battery.)
研究者
Dr Soumya S
Shri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru