Comparative efficacy of Nutrimind-2 and Cocoa based supplement in Social media -induced anxiety in young adults : A Randomized Controlled Study.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 46
- 试验地点
- 1
研究概览
简要总结
This is a Randomized Controlled Trial which evaluates efficacy of Nutrimind-2 which is a herbal neutraceutical and Cocoa based supplement in Social media-induced anxiety in young adults. A total no of 23 participants will be enrolled per group. Participants will be allocated randomly by computarized sampling. It is an open label study. A Group will receive Nutrimind-2 as an intervention and Group B will receive Cocoa supplement. Dose is 15 gm OD in both groups. Follow up is scheduled at 15th and 30th day. Outcomes will be analyzed by various scales like Hamilton Anxiety Rating Scale, Social Media Disorder Scale, Perceived Stress Scale, FOMO Scale.
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
- 18.00 Year(s) 至 28.00 Year(s)(—)
- 性别
- All
入选标准
- •Self-reported active use of social media, defined as engagement exceeding 4 hours per day, corroborated by device-based screen time evidence at the time of screening.
- •Male or female participants, aged 18 to 28 years
- •A score between 2 and 9 on the Social Media Disorder Scale (SMDS).
- •A score between 18 and 24 on the Hamilton Anxiety Rating Scale (HAM-A).
- •Not currently receiving any anxiolytic therapy, including pharmacological or herbal preparations, whether prescription or over-the-counter.
- •Provides written informed consent voluntarily, in accordance with ICH-GCP guidelines and applicable local ethical regulations, prior to the initiation of any study-related procedures.
排除标准
- •Current or past diagnosis of major psychiatric or neurological disorders.
- •Use of anxiolytic, antidepressant, or mood-altering medications within the last 30 days prior to screening.
- •Known allergy or intolerance to any components of the NutriMind-2 or cocoa-based formulation.
- •Pregnancy, lactation, or any chronic medical condition (e.g., diabetes, thyroid disorders, cardiovascular disease) that may interfere with study outcomes or participant safety.
研究者
Dr Prajakta Pawar
Dr. D.Y Patil College of Ayurved and Research Centre,Pimpri, Pune
