A 3-month, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Medha-Plus®, an Ayurvedic Formulation to Improve Cognitive Function in Adolescence
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Overall Cognitive function assessed by Child and Adolescent Memory Profile (ChAMP) at 3 month
研究概览
简要总结
This study is a randomized, double blind, placebo control group, single centre trial comparing the safety and efficacy of Medha Plus Syrup 5 ml daily and Vitamin B Complex syrup 5 ml daily for 3 months in 70 adolescent participants (12-18 years) to improve cognitive function.
The primary outcome measures are Child and Adolescent Memory Profile (ChAMP) at 3 months. The secondary outcomes are IQ by WISC-V Scales for Children at 3 months.
The subjects are divided following the prefixed blinding and masking rule into two arms: Test group: 5 ml Medha Plus (p.o), and Placebo: Identical color Vitamin syrup (p.o), preferably 30 min before bedtime for 3 months.
The treatment duration are consist of 4 visits, including the screening visit or baseline visit (V1), Follow-up I (V2), Follow-up II (V3) and final visit or Follow-up III (V4). Reliable instruments (ChAMP, PHQ-9, WISC-V) are used to evaluate overall cognitive functions and health condition. Laboratory safety parameters (CBC, TSH, renal function, and liver function) are evaluated at the screening visit and at the final visit. The occurrence of all AE data are monitored.
After unmasking, all variables will be presented in groups and statistically compared according to their nature. The performance of efficacy and safety of Medha Plus will be compared with baseline and placebo. A value of P < 0.05 will be considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 12.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy school age children in the cohort, Education level grades 5 to12 in high school, ChAMP score less than 100 for 12-13 yrs and less than 85 for 14 to15 yrs and less than 75 for 16-18 years, PHQ9 score less than 10 for all, WISC score more than70 for all, Do not use any vitamins or herbal remedies on a regular basis for at least six months.
排除标准
- •History of any neurological disorders like epilepsy, ADHD, dyslexia etc., History of congenital deformity, Thyroid dysfunction TSH less than 0.5 or more than 5.0 mIU per L, Severe anemia Hb more than 8 g percent, Unwillingness to participate, Use of any medications or supplements which, in the opinion of the investigators, may influence the results of the study.
结局指标
主要结局
Overall Cognitive function assessed by Child and Adolescent Memory Profile (ChAMP) at 3 month
时间窗: Overall Cognitive function assessed by Child and Adolescent Memory Profile (ChAMP) at at baseline, 1 month, 2 month, 3 month
次要结局
- Changes in Patient Health Questionnaire (PHQ-9) at 3 months and Changes in IQ by WISC-V (Wechsler’s Intelligence Scales for Children) at 3 months.(3 months)
研究者
Dr Srikanta Pandit
Associate Professor, Dept. of Kayachikitsha J. B. Roy State Ayurvedic Medical College and Hospital