A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ashwagandha in stress disorders
Trial Snapshot
- Phase
- Unknown
- Status
- Completed
- Sponsor
- The Himalaya Drug Company
- Enrollment
- 50
- Locations
- 2
- Primary Endpoint
- Efficacy of Ashwagandha caplets in stress disorders in
Study Overview
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.
Study Design
- Study Type
- Observational
Eligibility Criteria
- Ages
- 18.00 Year(s) to 65.00 Year(s) (—)
- Sex
- All
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.
Outcomes
Primary Outcomes
Efficacy of Ashwagandha caplets in stress disorders in
Time Frame: 90 days
providing rapid symptomatic recovery
Time Frame: 90 days
Secondary Outcomes
- Safety of Ashwagandha caplets in stress disorders(Provide rapid symptomatic recovery)