Study of Ashwagandha (Withania somnifera) in stress disorder

Phase 4

Completed

• Registration Number: CTRI/2016/10/007353
• Lead Sponsor: Shri Kartikeya Pharma

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 50

Inclusion Criteria

1.Adult male or female patients aged between 18 â?? 60 years of age

2.Patients with routine work stress

3.Patients stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc.

4.Patients with Perceived Stress Scale (PSS) score more than or equal to 20 (high stress level)

5.Body mass index between 25 and 39.9 kg/m2

Exclusion Criteria

1.Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data

2.Currently (in the past three months) attending a weight loss program

3.Underlying genetic or endocrine cause for weight gain

4.Medications known to affect weight (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications)

5.History of Alcohol or smoking abuse

6.Have clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study

7.Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania

8.Patients with post traumatic disorder

9.Have an established practice of meditation for three or more months

10.Pregnant and lactating women

11.Subjects with known hypersensitivity to Ashwagandha

12.Participation in other clinical trials during previous 3 months

13.Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol

Study & Design

• Study Type: PMS
• Study Design: Not specified