Health Condition 1: F430- Acute stress reaction
Conditions
Interventions
Intervention1: Ashwagandha DSTR Capsules along with soc: Patient will be asked to consume 2 capsule once daily after dinner for total of 12 weeks duration along with SOC
Control Intervention1: Defined
Sponsors
M/s Synthite Industries Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Include both male and female, age between 18-60 years. 2.Score on the 10-item Perceived Stress Scale (PSS) ranging from 14 to 26 at the time of screening. 3.Free of psychiatric conditions other than stress, anxiety, mild to moderate depression and cognitive deficits in moderately stressed subjects as per the discretion of the Investigator. 4.Self-reported moderate stress, mild anxiety, or depression 5.Willing and able to provide written informed consent prior to performing study procedures. 6.Participants experiencing reduced stamina and strength, as assessed by subjective reporting. 7.Women of childbearing potential and men who partner with a woman of childbearing potential must agree to use contraceptive methods. 8. Subjects willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: 1.Suffering from any chronic physical, hormonal or psychiatric illness. 2.Currently taking any herbal preparations or formulations for stress management (containing Ashwagandha, ginseng, ginkgo biloba, Brahmi or related herbs). 3.Drug abuse or aberrant laboratory findings during the screening. Medical history of clinically diagnosed severe depression, psychiatric disorder. 4.Currently taking mood stabilizer, anti-psychotic, anti-convulsion or any opioid â??based analgesics. 5.Allergy or sensitivity to any of the ingredients in the study treatment. 6.Subjects with serious, critical illness, or severe mental illness. 7.Any other condition, which the Principal Investigator thinks, may jeopardize the study. 8.Known history of human immunodeficiency virus (HIV) infection or acquired immunodeficiency syndrome (AIDS) related illness and/or known history of Hepatitis B virus (HBV), defined by presence of hepatitis B surface antigen (HBsAg) and/or known history of Hepatitis C virus (HCV), defined by presence of hepatitis C antibody (HCVAb). 9.Pregnant or lactating women. 10.Taking any of the following classes of medications: benzodiazepines, central nervous system depressants, immune suppressors, cardiovascular medication.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Evaluate efficacy of Ashwagandha in terms of decrease in score of Perceived Stress Scale (PSS)Timepoint: 1 from Screening visit to End of treatment (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1 Depression anxiety and stress as measured by decrease in score of Depression and Anxiety Stress Scale 21 2 Evaluate efficacy of Ashwagandha in terms of decrease in score of Hamilton- Anxiety 3 Improvement in Work Productivity and Activity Impairment Questionnaire 4 Increase in the WHO-5 Well-Being Score 5 Improvement in International Physical Activity QuestionnaireTimepoint: 1 from Baseline visit to End of treatment (week 12) 2 from Baseline visit to End of treatment (week 12) 3 from Baseline visit to End of treatment (week 12) 4 from Baseline visit to End of treatment (week 12) 5 from Baseline visit to End of treatment (week 12) | — |
Countries
India
Contacts
Public ContactMr Chandu Devanpally
Ardent Clinical Research Services
Outcome results
None listed