To check the Efficacy and Safety of Ashwagandha DSTR Capsule in patients with Moderate Stress Mild Anxiety Depression Low Stamina and Strength
- Conditions
- Health Condition 1: F430- Acute stress reaction
- Registration Number
- CTRI/2024/06/069402
- Lead Sponsor
- M/s Synthite Industries Private Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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 –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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 1 Depression anxiety and stress as measured by decrease in score of Depression and Anxiety Stress Scale 21 <br/ ><br>2 Evaluate efficacy of Ashwagandha in terms of decrease in score of Hamilton- Anxiety <br/ ><br>3 Improvement in Work Productivity and Activity Impairment Questionnaire <br/ ><br>4 Increase in the WHO-5 Well-Being Score <br/ ><br>5 Improvement in International Physical Activity QuestionnaireTimepoint: 1 from Baseline visit to End of treatment (week 12) <br/ ><br>2 from Baseline visit to End of treatment (week 12) <br/ ><br>3 from Baseline visit to End of treatment (week 12) <br/ ><br>4 from Baseline visit to End of treatment (week 12) <br/ ><br>5 from Baseline visit to End of treatment (week 12)