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临床试验/CTRI/2021/03/031920
CTRI/2021/03/031920已完成未知

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

AP Organics Limited0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
未知
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 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

排除标准

  • 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.

研究者

发起方
AP Organics Limited

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