A randomized, double-blind standard controlled trial Comparing two leading brands of Ashwagandha products in patients suffering from mental health-related symptoms like stress, anxiety, depression, and sleep disorders.

Comparison of two leading brands of Ashwagandha products in patients suffering from mental health related symptoms like stress, anxiety, depression and sleep disorders: A randomized, double-blind, standard controlled trial.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2023/01/049214

Enrollment

Registered

2023-01-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-07-22

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

Conditions

Health Condition 1: F411- Generalized anxiety disorder Health Condition 2: F330- Major depressive disorder, recurrent, mild Health Condition 3: F439- Reaction to severe stress, unspecified

Interventions

Intervention1: Ashwagandha Capsules of Herbochem: Ashwagandha Capsules of Herbochem 500 mg, Once Daily, Orally for 90 Days. Control Intervention1: KSM 66 Ashwagandha 600 mg Capsules: KSM 66 Ashwagandh

Eligibility

Inclusion criteria

Inclusion criteria: 1. Patients of either sex between 18 and 60 years of age 2. Patients suffering from mental health-related symptoms of with stress, anxiety, depression, and sleep disturbance. 3. Patients providing written informed consent

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating patients 2. Patients with liver and kidney impairment 3. Patients addicted to alcohol or psychotropic drugs 4. Patients with severe other psychiatric illnesses 5. Patients who have participated in any clinical trial in the last six months 6. Patients taking Ayurvedic medicines containing Ashwagandha.

Design outcomes

Primary

Measure	Time frame
• Reduction in Hamilton Depression Scale Score on day 30, 60 and 90, from baseline score on day 0 • Reduction in Beck Anxiety Inventory score on day 30, 60 and 90, from baseline score on day 0 • Reduction in Perceived Stress Score on day 30, 60 and 90 from baseline score on day 0 • Improvement in Pittsburgh Sleep Quality Index on day 30, 60 and 90 from baseline score on day 0Timepoint: Day 0, 30, 60 & 90	—

Measure

Time frame

• Reduction in Hamilton Depression Scale Score on day 30, 60 and 90, from baseline score on day 0 • Reduction in Beck Anxiety Inventory score on day 30, 60 and 90, from baseline score on day 0 • Reduction in Perceived Stress Score on day 30, 60 and 90 from baseline score on day 0 • Improvement in Pittsburgh Sleep Quality Index on day 30, 60 and 90 from baseline score on day 0Timepoint: Day 0, 30, 60 & 90

—

Secondary

Measure	Time frame
• Reduction in Serum Cortisol level on day 30, 60 and 90 from baseline level on day 0Timepoint: Day 0, Day 30, Day 60 & Day 90	—

Countries

India

Contacts

Public ContactMr Ayan Neogi

Vivforever Aesthetics Pvt. Ltd

ayanneogi@gmail.com9967968612

Outcome results

None listed

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