Evaluation of Efficacy and Safety of AshwaDaat® Capsule in subjects with Stress and Insomnia – An Open label, multi center, non-comparative, interventional, prospective clinical study
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in stress on perceived stress scale (PSS)
研究概览
简要总结
It is an open label, multi center, non-comparative, interventional, prospective clinical study to evaluate efficacy and safety of AshwaDaat® Capsule in subjects with Stress and Insomnia. The study will be conducted at two sites in India. Subjects will be advised to take AshwaDaat® in a dose of 2 Capsules twice daily orally after meals with water for a period of 30 days. The primary objective of the study will be to assess changes in stress on perceived stress scale (PSS) over a period of one month. The secondary objectives of the study will be to assess changes in severity of Insomnia on Insomnia Severity Index, change in pre and post serum cortisol (morning) level, change in Quality of Life on GHQ28 Scale , changes in safety assessment parameters like vitals including blood pressure, pulse rate, respiration rate and body temperature, assessment of occurrence adverse event, global assessment for overall change by investigator and subject on CGI Scale, assessment of tolerability of study drug by investigator and subject, assessment of safety by assessing safety lab parameters.
Results:
There was statistically significant reduction in stress and insomnia with the use of Ashwadaat®. A significant improvement in sleep quality along with improvement of quality of life (QOL) was seen at day 15 and day 30 as compared to the baseline scores. There was a reduction in morning Serum cortisol levels (within normal range) from baseline to 30 days. Excellent tolerability was reported over 30 days of consumption of Ashwadaat®. There were no adverse effects due to the consumption of Ashwadaat® and also the safety related laboratory parameters were within the normal range at baseline and further at the end of the study.
Conclusion: Ashwadaat® was found to be effective in reduction of stress and other associated symptoms, also effective in improving sleep quality, quality of life, without producing any adverse effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
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 between 14 -24 on the Perceived Stress Scale (PSS) 2.Subjects not having any psychiatric conditions other 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 on treatment for stress and insomnia 3.Subjects using oral or systemic contraceptive medications 4.Subjects with uncontrolled diabetes and hypertension 5.Subjects with substance dependence
- •Chronic alcoholics and Habitual Tobacco chewers.
- •7.Known cases of Severe/Chronic hepatic or renal disease.
- •8.Known case of any active malignancy.
- •9.Subjects giving history of significant cardiovascular event < 12 weeks prior to recruitment.
- •10.Subjects having known chronic, contagious infectious disease, such as active tuberculosis, Hepatitis B or C, or HIV.
- •11.Known case of having active metabolic or gastrointestinal diseases that may interfere with nutrient absorption, metabolism, or excretion, excluding diabetes.
- •12.Subjects using any other investigational drug within 1 month prior to recruitment or Subjects currently participating in any other Clinical study 13.Known hypersensitivity to any of the ingredients used in study drug 14.Pregnant and Lactating females.
- •15.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
Changes in stress on perceived stress scale (PSS)
时间窗: Day -3, Day 0, Day 15, Day 30
次要结局
- 1.Changes in severity of Insomnia on Insomnia Severity Index(2.Change in pre and post serum cortisol (morning) level)