A comparative clinical study on the efficacy of Haritakyadi Avleha and Shatpushpadi Churna as Medhya Rasayana in school going children
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
Study Design:- Interventional, two-arm, open-label, comparative clinical study.
Study Setting:
• The study will be conducted in the Department of Kaumarbhritya, Sanjeevani Hospital, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurveda University (DSRRAU), Jodhpur.
• Additionally, primary schools in Jodhpur and surrounding areas will serve as recruitment sites.
•Detailed clinical and demographic information of participants will be recorded in a specially designed case record form (CRF).
Study Groups:
• Participants will be randomly allocated into two groups.
Randomization Method:
• Simple randomization using computer-generated random numbers.
Sample Size: A total of 80 school-going children will be enrolled (40 in each group).
Study Duration:
• 30 days of intervention per participant.
Follow-up and Monitoring:
• Participants will be assessed fortnightly during the intervention period.
• Post-intervention follow-up will be conducted on the 45th day and the 60th day to evaluate sustainability of outcomes.
Study End Point:
• Efficacy assessment of Haritakyadi Avleha and Shatpushpadi Churna as Medhya Rasayana.
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
- 6.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Children aged 6–12 years, of either sex.
- •2.Children with average memory level and normal IQ.
排除标准
- •Children below 6 years or above 12 years of age.
- •Children with systemic disorders (e.g., gastrointestinal, neurological, or metabolic disorders).
- •Children with learning disabilities.
- •Children with mental illnesses such as schizophrenia, epilepsy, etc.
- •Children with mental retardation due to genetic or congenital causes.
研究者
Dr Yogesh Ratan Bagauriya
Post Graduate Institute of Ayurveda, Jodhpur