Efficacy of Vruddhadharuka Rasayana in Comparision to Shatapushpa Choorna on Enhancement of Intelligence Quotient in School 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
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Intelligence quotient based upon – “MALIN’S INTELLIGENCE SCALE FOR INDIAN CHILDREN” [MISIC]
研究概览
简要总结
A randomized controlled clinical trial on the efficacy of Vruddhadharuka Rasayana in comparision to Shatapushpa Choorna on enhancement of Intelligence Quotient in school children aged 10 to 16 years.
A minimum of 30 School children aged 10 to 16 years will be screened for IQ score ranging 70–109 [Borderline IQ -70 to 79, Low Average-80 to 89, Average-90 to 109; Scores obtained after conducting verbal and performance subtests - based upon Malin’s Intelligence Scale for Indian Children], followed by recruitment under parental consent for a period of 30 days.
During the study period the school children will be divided into two groups, Group A (trial drug) and Group B (control drug) with 15 children in each group, Group A children will receive Vruddhadharuka Rasayana and Group B children will receive Shatapushpa Choorna in a dose of 6 grams, morning and night, before food with Ghrita and Madhu as Anupana for about 30 days.
Clinical assessment will be done on 0th and 30th day for both subjective and objective criteria using Malin’s Intelligence Scale for Indian Children (MISIC), Buddhi assessment scale and WHO Quality of life index and statistical analysis will be done by considering the data obtained on 0th and 30th day.
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
- 10.00 Year(s) 至 16.00 Year(s)（—）
- 性别
- All
入选标准
- •School children of age group 10 to 16 years irrespective of sex, caste, religion, socio economic status with IQ score ranging 70 to 109, which is Borderline IQ 70 to 79, Low Average IQ 80 to 89, Average IQ 90 to 109, Scores obtained after conducting verbal and performance subtests based upon Malin’s Intelligence Scale for Indian Children, Willing and able to participate and ready to sign consent form.
排除标准
- •Children of age below 10 years and above 16 years.
- •Children having Intelligence quotient level less than 70 and more than 109, Scores obtained after conducting verbal and performance subtests based upon Malin’s Intelligence Scale for Indian Children.
- •Children with neurobehavioral disorders like ADHD, Autism, Intellectual disability, psychiatric illness, personality disorders, congenital abnormalities, genetic disorders.
- •Children suffering from any chronic illness, systemic disorders and on treatment, which may turn out to be hindrance in the study.
结局指标
主要结局
Improvement in Intelligence quotient based upon – “MALIN’S INTELLIGENCE SCALE FOR INDIAN CHILDREN” [MISIC]
时间窗: 30 days
Improvement in Functional aspect of Buddhi Based upon – “BUDDHI ASSESSMENT SCALE”
时间窗: 30 days
次要结局
- To evaluate the efficacy of Vruddhadharuka Rasayana in improving the quality of life in School children based upon – “WHO QUALITY OF LIFE INDEX.
研究者
Dr Nisarga S
Sri Dharmasthala Manjunatheshwara Institute of Ayurveda and Hospital, Bengaluru