CTRI/2022/05/042935
Not yet recruiting
未知
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Study to Evaluate the Efficacy and Safety of ViphyllinTM on Brain Health and Cognitive function in Healthy Subjects.
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Vidya Herbs Pvt Ltd
- Status
- Not yet recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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
Outcomes
Primary Outcomes
Not specified
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