A Randomized Double-Blind Placebo-Controlled study on Adolescent school going Children’s Intelligence with Medhya Rasayan.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary outcome-
研究概览
简要总结
A Randomized Double-Blind Placebo-Controlled Study on Adolescent School-Going Children’s Intelligence with Medhya Rasayan
This Ph.D. research by Dr. Neha Kumawat under the guidance of Dr. Suhas A. Chaudhary at CCRAS Jaipur aims to evaluate the role of Medhya Rasayan in enhancing intelligence among adolescents. Academic pressure during the age of 10–15 years often affects memory, attention, and problem-solving skills. While synthetic IQ boosters are widely available, their safety and efficacy remain questionable. Ayurveda mentions Medhya Rasayan like Shankhapushpi, Yashtimadhu, Guduchi*,* and Mandukaparnias natural cognitive enhancers, but scientific validation is limited. A total of 100 children with average IQ will be enrolled in a randomized, double-blind, placebo-controlled trial for 120 days. Participants will be divided equally into Medhya Rasayan and placebo groups, with assessments using MISIC and Ayurvedic parameters of Buddhi. Safety will be ensured through haematological and biochemical tests. The study expects significant improvement in IQ and cognitive abilities in the treatment group, thereby providing scientific evidence for the efficacy and safety of Medhya Rasayan in adolescent children. This research intends to bridge traditional Ayurvedic wisdom with modern scientific validation for cognitive enhancement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 10.00 Year(s) 至 15.00 Year(s)（—）
- 性别
- All
入选标准
- •Adolescent age group children i.e. 10 to 15 years of either sex.
- •Children with average IQ 89 to 109 with Malins scale.
- •Assent and consent both should be provided by parents/guardians and child.
- •Patient should be capable of obeying the instruction related to course of therapy.
- •Willingness to follow the treatment regimen and attend follow up sessions.
排除标准
- •Children with diagnosed neurological disorders (e.g., ADHD, ASD etc.).
- •I.Q. below 89 and above
- •Use of psychotropic medications during the study.
- •Known allergies to trial drugs or ingredients.
- •Patient/Attendant not willing to give written consent for participation in the research study.
结局指标
主要结局
Primary outcome-
时间窗: (Baseline and End of 90th Day)
Changes in IQ: - To evaluate the effects of the Medhya Rasayan extract capsule on the intelligence of children (IQ) through MISIC.
时间窗: (Baseline and End of 90th Day)
次要结局
- Changes in Ayurvedic Parameters: - To evaluate the effects of the Medhya Rasayan extract capsule on the Ayurvedic Parameters i.e. Medha, Smiriti, Dhriti, Vigyana.((Baseline, 15th day, 30th day, 45th day, 60th day, 75th day and 90th Day))
- To evaluate the safety of drug through laboratory investigations.((Baseline and End of 90th Day))
研究者
Dr Neha Kumawat
R.B. Ayurved Medical College & Hospital, Agra