Effect of gamma oryzanol on immunity in healthy volunteers

Not Applicable

Completed

• Registration Number: CTRI/2021/03/031920
• Lead Sponsor: AP Organics Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2021-12-13
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean �Changes in baseline value of Th1 and Th2 cytokines (interferon-gamma and interleukin-4), IgA, IgG, IgM and IgE , baseline counts of T-cell (CD4+, CD8+), B-cell (CD19), TNF-alpha and NK-cells (CD16+, CD56+), IL-2, IL-4, IL-6, IL-8 and IL-10, Mean percent changes in baseline values of serum cortisol (at 0 day, 30th day and 60th day) and CRP levels between the groups.Timepoint: Mean �Changes in baseline value of Th1 and Th2 cytokines (interferon-gamma and interleukin-4), IgA, IgG, IgM and IgE , baseline counts of T-cell (CD4+, CD8+), B-cell (CD19), TNF-alpha and NK-cells (CD16+, CD56+), IL-2, IL-4, IL-6, IL-8 and IL-10, Mean percent changes in baseline values of serum cortisol (at 0 day, 30th day and 60th day) and CRP levels between the groups.

Secondary Outcome Measures

Name	Time	Method
i.To assess the adverse drug reactions in both group <br/ ><br>ii.Mean percent changes between gamma-oryzanol and placebo trial arms from baseline to 60 days as in: <br/ ><br>a.Basic vital signs <br/ ><br>b.Liver function tests <br/ ><br>c.Kidney function tests <br/ ><br>d.Thyroid function tests <br/ ><br>e.Lipid profile <br/ ><br>Timepoint: ADR monitoring will be through out the study duration, and rest rest of the parameters will be assessed on 0 day, 30th day and 60th day of the treatment