Clinical Study on Ayumem Capsule in Stress and Insomnia.

Phase 2/3

Completed

Brief Summary: 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

Recruitment & Eligibility

Inclusion Criteria

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.

Exclusion Criteria

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.

Primary Outcome Measures

Name	Time	Method
Assessment of Ayumen Capsules on stress using perceived stress scale (PSS) in comparison to placebo	Day-3, Day 0, Day 30, Day 60

Secondary Outcome Measures

Name	Time	Method
1.Assessment of Ayumem Capsules on stress using perceived stress scale	2.Assessment of severity of Insomnia on Insomnia Severity Index.

Locations (2): KVTR Ayurvedic College and Hospital Boradi
🇮🇳
Dhule, MAHARASHTRA, India
S.D.M. College of Ayurveda, Kuthpady,Udupi
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Udupi, KARNATAKA, India
KVTR Ayurvedic College and Hospital Boradi
🇮🇳Dhule, MAHARASHTRA, India
Dr Narendrakumar B Mundhe
Principal investigator
9850378206
drnbmundhe@gmail.com