Efficacy and Safety of Ashwagandha in Stress Disorders.

Not Applicable

Completed

• Conditions: Stress disorders characterized by Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion.

• Registration Number: CTRI/2016/06/007006
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

**In this Double Blind, placebo controlled, randomized study, ashwagandha extract caplets are evaluated clinically** **versus placebo** **for efficacy and safety in patients with stress disorders. Otherwise normal male/female patients above 18 years of age presenting with** Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion are included in the study after obtaining informed consent. Symptoms  assessed are difficulty in concentration, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion. Assessment done on a 0-10 VAS. The overall clinical assessment is defined as cured, improved and unchanged.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-11-05
• Last Update Posted: 2013-09-26

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion etc.
• Age >18 years, both male and female subjects.
• Hematologic and Biochemical parameters within normal limits.

Exclusion Criteria

• Patients with severe Psychiatric conditions.
• Pregnant & Breast feeding Women.
• Patients with severe Hepatic/ cardiac/ mental illness.
• History of Alcohol or smoking abuse.
• Patients unwilling to provide informed consent or abide by the requirements of the study.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of Ashwagandha caplets in stress disorders in	90 days
providing rapid symptomatic recovery	90 days

Secondary Outcome Measures

Name	Time	Method
Safety of Ashwagandha caplets in stress disorders	Provide rapid symptomatic recovery

Trial Locations

Locations (2)

Atur Sangtani, Red Cross House; 🇮🇳 Pune, MAHARASHTRA, India

Grant Medical College & Sir J.J. Group of hospitals.; 🇮🇳 Mumbai, MAHARASHTRA, India

Atur Sangtani, Red Cross House

🇮🇳Pune, MAHARASHTRA, India

Dr Dnyanraj Choudhary

Principal investigator

9823217423

dr.dnyanrajc@yahoo.co.in