To determine the effect and health benifits of an Ashwagandha (Withania somnifera) extract in healthy, stressed adult volunteers

A randomized, double-blind, placebo-controlled study evaluating the efficacy, safety, tolerability, and pharmacological actions of an Ashwagandha (Withania somnifera) extract in healthy, stressed adult volunteers

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2017/08/009449

Enrollment

Registered

2017-08-22

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

None listed

Interventions

Intervention1: Ashwagandha: Ashwagandha 240 mg â??0â?? sized Ashwagandha extract(Withania Somnifera) capsule to be taken orally with 250 ml of water daily for 60 days. Control Intervention1: Placebo:

Eligibility

Inclusion criteria

Inclusion criteria: 1. Male or female healthy volunteers aged between 18 and 65 years. 2. Healthy subjects with a total score between 6 to 17 on the Hamilton Rating Scale of Anxiety. 3. Healthy subjects willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1. Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control 2. Healthy subjects with known hypersensitivity to test drug or any of the excipients of this extract 3. Patients with acute narrow angle glaucoma. 4. Patients with prostate hypertrophy. 5. Patients suffering from alcohol dependence. 6. Patients having severe renal and hepatic impairment. 7. Patients reporting suicidal intent or known suicidal tendencies 8. Patients currently or in the past 6 months suffering from any diagnosable mental health disorder (as assessed by the MINI 6.0) or have a history of malignancy of any organ system 9. Patients currently (or within the past 6 months prior to screening) taking any psychotropic medicines (e.g. anti-depressant, benzodiazepine, antipsychotic or mood-stabilizer, MAO inhibitor) or herbal preparation. 10. Patients with co-morbid illnesses such as cardiovascular, endocrine, renal or other chronic disease likely to affect stress/anxiety or limit normal function 11. HIV, HBsAg and/or a HCV positive subjects 12. Patients taking any other investigation Drug and currently being a part of any other clinical trial/research.

Design outcomes

Primary

Measure	Time frame
1. Change in total score on Hamilton Anxiety Rating Scale (HAM-A) from baseline to endpoint compared across two conditions (placebo and test product)Timepoint: Baseline, day 15, day 30, day 45 and day 60	—

Secondary

Measure	Time frame
2. Change in total score and subscale scores on the Depression Anxiety Stress Scale (DASS-21) from baseline to endpoint compared across two conditions (placebo and test product) 3. Change in morning blood cortisol, testosterone level and DHEA-s from baseline to endpoint compared across two conditions (placebo and test product) Timepoint: Baseline, day 15, day 30, day 45 and day 60 Baseline, day 30 and day 60 (for Cortisol and DHEA-S) Baseline, day 60 (for Testosterone Level)	—

Measure

Time frame

2. Change in total score and subscale scores on the Depression Anxiety Stress Scale (DASS-21) from baseline to endpoint compared across two conditions (placebo and test product) 3. Change in morning blood cortisol, testosterone level and DHEA-s from baseline to endpoint compared across two conditions (placebo and test product) Timepoint: Baseline, day 15, day 30, day 45 and day 60 Baseline, day 30 and day 60 (for Cortisol and DHEA-S) Baseline, day 60 (for Testosterone Level)

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Countries

India

Contacts

Public ContactYogendra Choudhary

Arjuna Natural Extracts Ltd

drbinu@arjunanatural.com0484-2532404

Outcome results