None listed
Conditions
Interventions
Intervention1: Ashwagandha root extract granules SR capsules 150 mg: 1 capsule of Ashwagandha root extract granules SR capsules 150 mg Capsules to be o orally administered with
water once daily after
Sponsors
Nutriventia Limited
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Male or female subjects aged between 20-55 years (both inclusive) with BMI 18 to 30 kg/m2 (both inclusive). 2. Healthy subjects as determined by: Medical history, Physical examination, and clinical judgment of the investigator. 3. Subjects who perceive themselves to be under stress and having a score of 14-26 on the Perceived Stress Scale (PSS) 4. Female subjects of childbearing potential must be using a medically acceptable form of birth control. Female subjects of non-childbearing potential must be amenorrheic for at least 1 year or had a hysterectomy and/or bilateral oophorectomy. 5. Results of screening are within normal range or considered not clinically significant by the Principal Investigator. 6. Subjects, who, in the opinion of the investigators have a fair level of comprehension to clearly understand the objectives of the study specific outcome measures. 7. Willing to provide voluntary consent by signing the informed consent form and comply with study procedures.
Exclusion criteria
Exclusion criteria: Exclusion Criteria 1. Subjects younger than 20 years or older than 55 years. 2. Subject with hypersensitivity to any of the ingredients of the study products. 3. Female subjects who are pregnant, breast feeding or planning to become pregnant. 4. Current or recent major psychiatric illness that meets Diagnostic and Statistical Manual of Mental Disorders-V (DSM-V) criteria3 (i.e., depression, anxiety, bipolar disorder, schizophrenia etc.). 5. Subjects with any significant uncontrolled systemic illness (including but not limited to uncontrolled hypertension, stroke, epilepsy, myocardial infarction, coronary artery disease, cardiac failure, type I or type II DM, renal or hepatic failure, sexually transmitted diseases (STDs), HIV or AIDS. 6. Concurrent use of supplements to alleviate or improve stress/anxiety/mood/sleep/ for any other indications, herbal or pharmaceutical aphrodisiacs, body composition enhancing agents, or other concurrent medication such as betablockers, contraceptives, and psychotropic medications. 7. Subjects who are alcohol dependent and have established substance abuse concerns. 8. Subjects who are on any medication/treatment for infertility/enhancement of sexual function within 6 months prior to study enrollment. 9. Difficulty in swallowing and retaining oral formulation. 10. Any history of difficulty in accessing veins to draw blood. 11. Any condition that is in the opinion of the Investigator does not justify the Subjectsâ?? participation in the study. 12. Participation in any other trials involving investigational or marketed products within 30 days prior to the Screening Visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 Change in Perceived Stress Scale (PSS) Timepoint: 1.screening to End of Study- Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Pittsburgh Sleep Quality Index (PSQI) 2.Serum testosterone level (free & total, in male subjects only),serum cortisol level (9-11 AM) 3. Three-Factor Eating Questionnaire- Revised 18 (TFEQ-R18) 4.Subjectâ??s self-assessment of Oxford Happiness questionnaire (8-item) 5. Comparison of Patients & physicians global assessment of therapy 6. Comparison of treatment emergent Adverse events (AEs). Timepoint: 1.from baseline to Day 03, Day 07, Day 15, Day 30, Day 45 & Day 60 2. baseline to Day 07, Day 30 & Day 60. 3.from baseline to Day 07, Day 30 & Day 60. 4.baseline to Day 03, Day 07, Day 15, Day 30, Day 45 & Day 60 5. end of the study. | — |
Countries
India
Contacts
Public ContactT Vijaya Bhaskar
iVRS Pvt Ltd
Outcome results
None listed