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Clinical Trials/CTRI/2021/03/031920
CTRI/2021/03/031920
Completed
N/A

A randomized double blind clinical study to evaluate the effect of Gamma-oryzanol on immunity in healthy volunteers

AP Organics Limited0 sites30 target enrollmentTBD

Overview

Phase
N/A
Intervention
Not specified
Conditions
Not specified
Sponsor
AP Organics Limited
Enrollment
30
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
December 13, 2021
Last Updated
3 years ago
Study Type
Interventional

Investigators

Sponsor
AP Organics Limited

Eligibility Criteria

Inclusion Criteria

  • i.Healthy participants (health status confirmed by clinical history, Physical Exam and routine blood analysis) from both gender
  • ii.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.
  • iii.Participant must be able, willing and likely to fully comply with study procedures and restrictions.
  • iv.Participant willing to sign the informed consent

Exclusion Criteria

  • i.Evidence of renal disease (S. Creatinine \> 1\.5mg/ml)
  • ii.Evidence of liver disease (AST/ALT \>3 times of normal)
  • iii.Pregnant and lactating mothers and women intending pregnancy
  • iv.History of alcohol intake and smoking.
  • v.Participation in any other clinical trial with in the last 30 days
  • vi.History of intake of dietary supplements or any immunomodulatory drugs.
  • vii.Participants taking Rice bran oil in diet regularly.
  • viii.History of intolerance or hypersensitivity to gamma\-oryzanol.
  • ix.Any condition which in the opinion of the PI that is significant and can make the subject unsuitable for study or can place it under additional risk, such as intolerance, allergy to gamma\-oryzanol.

Outcomes

Primary Outcomes

Not specified

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