None listed
Conditions
Interventions
Intervention1: ksm66 ashwagandhaa: 250 mg orally BID for 8 weeks
Control Intervention1: Placebo: same
Sponsors
Ixoreal Biomed Priavte Limited,
#5-9-225, 3rd floor, Sanali estate, Chirag ali lane, Abids,
Hyderabad, Andhra Pradesh- 500001, India
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total score on DASS and GHQ-28 after 8 wkTimepoint: 0 day, 60 day | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the study and control group on PSS scores Comparison of the study and control groups on various laboratory measures and serum cortisol levels Comparison of the study and control group on PSS scores Comparison of the study and control groups on various laboratory measures and serum cortisol levels Timepoint: 0 day and 60 day | — |
Countries
India
Contacts
Public ContactDr.Shridhar Anishetty
Outcome results
None listed