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Efficacy and Safety of Ashwagandha in Stress Disorders.

A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ashwagandha in stress disorders

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/06/007006
Enrollment
50
Registered
2016-06-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- Stress disorders characterized by Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion.

Interventions

Intervention1: Caplet containing Withania somnifera extract: One caplet once daily orally for 3 months Control Intervention1: Placebo Caplet identical in shape and size to study drug: One Caplet once

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Efficacy of Ashwagandha caplets in stress disorders in providing rapid symptomatic recoveryTimepoint: 90 days

Secondary

MeasureTime frame
Safety of Ashwagandha caplets in stress disorders Provide rapid symptomatic recovery incidence of adverse events during the study period, and overall compliance to the drug treatmentTimepoint: 90 days

Countries

India

Contacts

Public ContactDr Pralhad Patki

The Himalaya Drug Company

dr.patki@himalayahealthcare.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026