A Randomized, Double blind, Placebo controlled, Multi-centric, Interventional, Prospective Clinical study to Evaluate Efficacy and Safety of Ayumem Capsule in subjects with Stress and Insomnia.
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo
研究概览
简要总结
It is a randomized, double blind, placebo controlled, multi-centric, interventional, prospective clinical study to evaluate efficacy and safety of Ayumem Capsule in subjects with Stress and Insomnia. The study will be conducted at two sites in India. As per computer generated randomization list, subjects will be advised to take either study product or placebo in the dose of 2 capsules twice daily for a period of 60 days. The primary objective will be assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo from baseline to 60 days. The secondary objectives will be assessment of Ayumem Capsules on stress using perceived stress scale, assessment of severity of Insomnia on Insomnia Severity Index, assessment of pre and post serum cortisol (morning), assessment of Quality of Life on GHQ28 Scale, assessment on vitals and adverse event, global assessment for overall change by investigator and Subject, assessment of tolerability of study drugs by investigator and subject, and assessment of lab parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects who perceive themselves to be under stress and having a score of between 14 -24 on the Perceived Stress Scale (PSS).
- •2.Subjects not having any other psychiatric conditions than stress.
- •3.Subjects willing to follow the procedures as per the study protocol and voluntarily sign an informed consent form.
排除标准
- •1.Subjects suffering from any chronic physical, hormonal or psychiatric illness.
- •2.Subjects using oral or systemic contraceptive medications.
- •3.Subjects with uncontrolled diabetes and hypertension.
- •4.Subjects with substance dependence.
- •5.Chronic alcoholics and Habitual Tobacco chewers.
- •6.Known cases of Severe/Chronic hepatic or renal disease.
- •7.Known subject of any active malignancy.
- •8.Subjects giving history of significant cardiovascular event <12 weeks prior to recruitment.
- •9.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •10.Known subjects of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •11.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study.
- •12.Known hypersensitivity to any of the ingredients used in study drug.
- •13.Pregnant and Lactating females.
- •14.Any other condition due to which patients are deemed to be unsuitable by the investigator for reason(s) not specifically started in the exclusion criteria.
结局指标
主要结局
Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo
时间窗: Day-3, Day 0, Day 30, Day 60
次要结局
- 1.Assessment of Ayumem Capsules on stress using perceived stress scale(2.Assessment of severity of Insomnia on Insomnia Severity Index.)