Efficacy of Ashwagandha extract on generalized anxiety disorder

Phase 2

Completed

• Registration Number: CTRI/2022/04/042133
• Lead Sponsor: Arjuna Natural Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-08-15
• Last Update Posted: 4 March 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 60

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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