None listed
Conditions
Interventions
Intervention1: Viwithan, Ashwagandha extract, 160 mg capsule: Oral administration of single dose of Viwithan 160mg capsule every night for 60 days
Control Intervention1: Sensoril, Ashwagandha extract,
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects with Hamilton anxiety scale scoring between 6 and 17. 2.Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening. 3.Subject understands the study procedures, is ready to comply and provide signed informed consent form (ICF) to participate in the study.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of • Diagnosable mental health disorder e.g., depression, anxiety disorder, eating disorder, psychosis/ schizophrenia • Severe neurological diseases or seizures • Uncontrolled / serious medical illness including diabetes, liver disease, hypertension • Cardiac Disease/Neurological Problems/ • Auto-immune disease (rheumatoid arthritis, lupus, type 1 diabetes) • Gastrointestinal tract bleeding / peptic ulcer disease • Acute narrow angle glaucoma • Prostate hypertrophy 2. Subjects with known hypersensitivity to Ashwagandha extract or allergic to any of the natural constituents of the Investigational Product. 3. Known HIV or Hepatitis B positive or any other immuno-compromised state 4. Subjectâ??s currently (or within the past 6 months prior to screening) taking any psychotropic medicines (e.g. anti-depressant, benzodiazepine, antipsychotic or mood-stabilizer, MAO inhibitor) or herbal preparation. 5. Subjects having symptoms of viral infection, including COVID-19 infection 6. History of smoking, alcohol/drug abuse 7. Subjects visually or mentally handicapped or having difficulty to communicate 8. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 9. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study. 10. Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in anxiety and stress levelsTimepoint: Day 0,Day 30, Day 60 | — |
Secondary
| Measure | Time frame |
|---|---|
| SafetyTimepoint: Day 0,Day 30, Day 60 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Pvt. Ltd.
Outcome results
None listed