Clinical Study on Ayumem Capsule in Stress and Insomnia.
- Conditions
- Health Condition 1: null- Stress and Insomnia
- Registration Number
- CTRI/2018/04/012984
- Lead Sponsor
- Welex Laboratories Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 61
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo <br/ ><br> <br/ ><br>Timepoint: Day-3, Day 0, Day 30, Day 60 <br/ ><br>
- Secondary Outcome Measures
Name Time Method 1.Assessment of Ayumem Capsules on stress using perceived stress scale <br/ ><br>2.Assessment of severity of Insomnia on Insomnia Severity Index. <br/ ><br>3.Assessment of pre and post serum cortisol (morning). <br/ ><br>4.Assessment of Quality of Life on GHQ28 Scale. <br/ ><br>5.Assessment on vitals and adverse event. <br/ ><br>6.Global assessment for overall change by investigator and Subject. <br/ ><br>7.Assessment of tolerability of study drugs by investigator and subject. <br/ ><br>8.Assessment of lab parameters <br/ ><br>Timepoint: Day-3, Day 0, Day 30, Day 60 <br/ ><br>