None listed
Conditions
Interventions
Intervention1: ViphyllinTM: Oral administration of single dose of ViphyllinTM 500mg capsule everyday for 84 days
Control Intervention1: Placebo: Oral administration of single dose of Placebo 500mg cap
Sponsors
Vidya Herbs Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Subjects with a MMSE Score >= 23 2. Diabetes, hypertension and other medical condition patients should be on stable medication for last 3 months 3. Should not be an any medication for cognition and other neurological disorders 4. Females of childbearing age, agree to use approved birth control methods during the study, and have negative urine pregnancy test (UPT) at screening 5. Non-smokers 6. Able to communicate verbally, able to write and speak English and comfortable with using computer 7. Must be willing and able to give informed consent and comply with the study procedures.
Exclusion criteria
Exclusion criteria: 1. Subjects with history of -Respiratory bacterial or viral infection (including COVID-19) in the past 2 weeks - Psychiatric disorders - 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 2. Subjects who maybe 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. Subjects on any other medical or clinical investigation or on any nutrition supplements and dietary regime. 5. Subjects visually or mentally handicapped or having difficulty to communicate 6. History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol. 7. Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Mean change in the biomarker levelsTimepoint: Day 0,42 and 84;Over all SafetyTimepoint: Day 0, 42 and 84 | — |
Primary
| Measure | Time frame |
|---|---|
| Mean change in cognitive function parametersTimepoint: Day 0, 42 and 84 | — |
Countries
India
Contacts
Public ContactJestin V Thomas
Leads Clinical Research and Bio Services Private Limited
Outcome results
None listed