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Clinical Trials/CTRI/2021/07/035080
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.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
AP Organics Limited

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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