Efficacy of Ashwagandha extract on generalized anxiety disorder

A randomized double-blind placebo-controlled study to determine the efficacy of ashwagandha extract on generalized anxiety disorder

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/04/042133

Enrollment

Registered

2022-04-25

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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 extract (SHPR): Ashwagandha extract 60mg, one capsule daily for 60 days Intervention2: Ashwagandha extract (SHPR): Ashwagandha extract 120mg , one capsule daily for 60 days

Eligibility

Inclusion criteria

Inclusion criteria: 1. Fulfilling the DSM –IV Criteria for Generalized Anxiety Disorder. 2. HAM-A total score > 20, Item 1 (anxious mood) = 2, Item 2 (tension) = 2. 3. Cortisol > 25 mcg/dl (morning (8– 9 am). 4. Clinical Global Impression-Severity of Illness (CGI-S) score = 4. 5. Healthy subjects willing to give their informed consent.

Exclusion criteria

Exclusion criteria: 1. Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 12, with MADRS items 1 and 2 "apparent sadness" and "reported sadness ? greater than or equal to 2. 2. Current serious suicidal or homicidal risk, MADRS Item 10 (suicidal thoughts) score greater than 1 at the screening or randomization visit or a suicide attempt in the 6 months prior to screening. 3. Night shift workers (8 pm to 8 am) 4. Subjects who have not participated in a similar investigation in the past three months. 5. Having psychotic tendencies such as schizophrenia or taking any psychotropic medicines. 6. Alcohol dependence, chain-smoking, any psychedelic, narcotic substance abuse. 7. psychotic tendencies such as schizophrenia or taking any psychotropic medicines. 8. co-morbid illnesses such as cardiovascular, endocrine, renal, or other chronic diseases likely to affect stress/anxiety or limit normal function. 9. Positive pregnancy, breastfeeding, pregnancy planning. 10. Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.

Design outcomes

Primary

Measure	Time frame
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A)Timepoint: Day 0 to Day 60	—

Secondary

Measure	Time frame
Change from Baseline in CBC, RFT, LFTTimepoint: From Baseline to days 0,30,60;Change from Baseline in Clinical Global Impression scoresTimepoint: From baseline to days 0,30,60;Change from Baseline in PGICTimepoint: From Baseline to days 0, 30,60;Change from Baseline in PSSTimepoint: From Baseline to days 0, 30, 60;Change from Baseline in the Cortisol levelTimepoint: From baseline to days 0,15,30,45,60;Change from Baseline in the HAM-A ScoreTimepoint: From baseline to day 15, 30, & 45	—

Measure

Time frame

Change from Baseline in CBC, RFT, LFTTimepoint: From Baseline to days 0,30,60;Change from Baseline in Clinical Global Impression scoresTimepoint: From baseline to days 0,30,60;Change from Baseline in PGICTimepoint: From Baseline to days 0, 30,60;Change from Baseline in PSSTimepoint: From Baseline to days 0, 30, 60;Change from Baseline in the Cortisol levelTimepoint: From baseline to days 0,15,30,45,60;Change from Baseline in the HAM-A ScoreTimepoint: From baseline to day 15, 30, & 45

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Countries

India

Contacts

Public ContactSooraj R Kartha

Arjuna Natural Private Ltd

sooraj@arjunanatural.com9288004381

Outcome results