None listed
Conditions
Interventions
Intervention1: Ashwagandha root extract 300 mg: 1 Capsule once daily after breakfast for 90 days
Control Intervention1: Placebo: 1 Capsule once daily after breakfast for 90 days
Sponsors
Inventia Healthcare Ltd
Laila Nutraceuticals
Eligibility
Inclusion criteria
Inclusion criteria: 1.Body Mass Index 18 to 29 kg/m2. 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 14-24 on the Perceived Stress Scale (PSS). 4.Cognitively sound (no cognitive impairment) subjects as identified with Montreal Cognitive Assessment (MoCA) test. 5.Subjects willing and able to provide written informed consent and agree to come for regular follow up. 6.Subject willing to comply with all study related procedures and requirements
Exclusion criteria
Exclusion criteria: 1.Female subjects who are pregnant or lactating or planning to become pregnant and / or unwilling to follow standard contraception methods. 2.Post- menopausal female subjects 3.Subjects with education level below 8th grade of schooling and unable to read or understand English. 4.History of drug dependence or any severe co-morbid medical conditions. 5.History or presence of any clinically significant systemic disease including but not limited to psychiatric, cardiovascular, pulmonary, neurological, hepatic, renal, metabolic, ophthalmologic, or any other medical condition including but not limited to uncontrolled hypertension, stroke, epilepsy, myocardial infarction, coronary artery disease, cardiac failure, type I or type II Diabetes Mellitus, renal or hepatic failure, sexually transmitted diseases (STDs),Human Immunodeficiency Virus (HIV) or Acquired Immunodeficiency Syndrome (AIDS) 6.History of psychiatric disorder that may impair the ability of subjects to provide written informed consent. 7.Subjects with significant medication use including but not limited to (psychotropic, antihypertensive, beta-blockers, inhaled beta agonists, corticosteroid use within prior three months.) 8.Subjects on high alcohol intake ( >2 standard drinks per day) or use of recreational drugs (such as cocaine, methamphetamine, marijuana, etc.)/ Nicotine or Caffeine dependence. 9.Subjects on multivitamins/herbal supplements/ any other wellness product 10.Subject who has participated in a clinical study within the last 30 days prior to entering this study. 11.Subject with hypersensitivity to any of the ingredients of the study products.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Baseline to the end of the study period in cognition as measured by CANTAB connect.Timepoint: Day 0 & Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from Baseline to the end of the study period in: 1. Perceived Stress Scale- 10 (PSS-10) score 2. Serum Cortisol level (9-11 am) 3. Oxford Happiness Questionnaire (OHQ) 4. The Pittsburgh Sleep Quality Index (PSQI) 5. Serum Brain Derived Neurotropic Factor 6. Adverse events (AEs), frequency and severity 7. Proportion of subjects who discontinue study treatment due to adverse events 8. Changes in vital parameters and laboratory investigations (CBC, AST, ALT and Serum Creatinine) Timepoint: Day 0 & Day 90 | — |
Countries
India
Contacts
Public ContactVijay Bhaskar T
In vitro Research solutions Pvt. Ltd,
Outcome results
None listed