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临床试验/CTRI/2012/06/002713
CTRI/2012/06/002713已完成1 期

An Open Labeled, Prospective, Single-center, Clinical Study to Evaluate the Safety of Jeevanprash (JP) in Healthy Individuals in Summer. - NI

Alkem Laboratories Ltd0 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
1 期
状态
已完成
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

  • Subjects meeting all of the following criteria will be included to the trial-
  • Males and Females, age group between 20-40 years
  • Ready to provide written informed consent
  • No significant diseases or clinically abnormal laboratory blood profiles during screening.
  • ECG without significant abnormalities
  • Be able to communicate effectively with study personnel
  • No history of allergic conditions and is not on regular medical treatment

排除标准

  • Subjects meeting any of the following criteria will be excluded from the trial-
  • Any significant disease condition which would affect subjectâ??s participation or compliance to study protocol
  • History of allergic conditions
  • History of autoimmune disorders
  • History of HIV I & II, Hepatitis.
  • History or presence of dyspepsia, gastric ulcer or duodenal ulcer.
  • History of any psychiatric disorders.
  • Intake of any medication within 14 days before the start of the study.
  • Recent history of alcoholism ( <2 years) or consumption of alcohol within 48 hours of receiving study medication.
  • Smokers who cannot refrain from smoking during the study period.
  • Presence of clinically significant abnormal laboratory results during screening.
  • Pregnancy or not using appropriate means of contraception.
  • History of drug addiction.

研究者

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