CTRI/2022/04/042133
Completed
Phase 2
A randomized double-blind placebo-controlled study to determine the efficacy of ashwagandha extract on generalized anxiety disorder
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Arjuna Natural Private Limited
- Enrollment
- 60
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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