CTRI/2021/07/035080
Suspended
N/A
A randomized double blind clinical study to evaluate the effect of Gamma-oryzanol on immunity and cognition in healthy volunteers
AP Organics Limited0 sites0 target enrollmentTBD
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- AP Organics Limited
- Status
- Suspended
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •i.Age above 18 years
- •ii.Healthy participants (health status confirmed by clinical history, Physical Exam and routine blood analysis) from both gender
- •iii.Participant must not have taken any vitamin / mineral/ dietary or herbal supplements, 1 month prior to enrolling in the study and agrees to not use any new vitamins and/or minerals and/or dietary and/or herbal supplements until after study completion.
- •iv.Participant must be able, willing and likely to fully comply with study procedures and restrictions.
- •v.Participant must be literate or have a basic primary education.
- •vi.Participant willing to sign the informed consent
Exclusion Criteria
- •Evidence of renal disease (S. Creatinine \> 1\.5mg/ml)
- •Evidence of liver disease (AST/ALT \>3 times of normal)
- •Pregnant and lactating mothers intending pregnancy
- •History of alcohol intake and smoking
- •Participation in any other clinical trial within the last 30 days.
- •History of intake of dietary supplements or immunomodulatory drugs.
- •Participants taking rice bran oil in their diet regularly.
- •History of intolerance or hypersensitivity to gamma oryzanol.
- •Clinically diagnosed with alzheimers disease.
- •Prior history of stroke, dementia, Parkinsons disease, fibromyalgia, multiple sclerosis, epilepsy or other known diseases that affect memory or cognition
Outcomes
Primary Outcomes
Not specified
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