Study of efficacy and safety of KSM-66 Ashwagandhaa (Withania somnifera Dunal) in stress and anxiety and on general well being in healthy adults.
Phase 1
Completed
- Registration Number
- CTRI/2011/091/000222
- Lead Sponsor
- Ixoreal Biomed Priavte Limited,#5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids,Hyderabad, Andhra Pradesh- 500001, India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 60
Inclusion Criteria
?Healthy adults of either sex, who are facing routine work stresses, who sign the Informed Consent Form.
?Age group 18 -54 years
?Can read , write and understand English
?Subjects with WHO-5 well being index < 15 or PSS scores >14
Exclusion Criteria
?Suffering from any chronic physical, hormonal or psychiatric illness
?Current substance dependence
?Individuals refusing to use appropriate non-hormonal birth control measures.
?Pregnancy / lactating mothers
?Currently taking any other medication on a regular basis
?Currently taking any herbal preparations (other formulations containing ashwagandha / ginseng / ginkgo biloba / brahmi etc)
?Clinically significant findings on laboratory investigations and ECG
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Total score on DASS and GHQ-28 after 8 wkTimepoint: 0 day, 60 day
- Secondary Outcome Measures
Name Time Method Comparison of the study and control group on PSS scores<br>Comparison of the study and control groups on various laboratory measures and serum cortisol levels<br>Comparison of the study and control group on PSS scores<br>Comparison of the study and control groups on various laboratory measures and serum cortisol levels<br>Timepoint: 0 day and 60 day