跳至主要内容
临床试验/CTRI/2022/09/045277
CTRI/2022/09/045277进行中(未招募)Phase 3 4

Pharmaceutical-Analytical study of Yashada bhasma and its estimation in serum of healthy human volunteers

Veda SM1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2022年8月9日最近更新:

试验速览

阶段
Phase 3 4
状态
进行中(未招募)
发起方
入组人数
20
试验地点
1
主要终点
Zinc level at different intervals. Zinc levels in serum increases gradually, reaches peak and declines.

研究概览

简要总结

The study will comprise of 20 healthy volunteers aged between 20 – 40 years after a written informed consent. The blood samples will be collected at 0, 1, 2, 3, 4, 5, 6 and 7 hours of supplementing 250 mg of Yashada bhasma. Serum Zinc levels are estimated with the above samples.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Open Label

入排标准

年龄范围
20.00 Year(s) 至 40.00 Year(s)(—)
性别
All

入选标准

  • Healthy volunteers from both genders aged between 20 to 40 years, free of any ailments and doing routine activities.

排除标准

  • Any subjects with diseases / disorders.
  • Pregnancy and lactation,
  • Sports persons,
  • physical exercising,
  • mental disorders,
  • alcoholics and drug abuse.
  • Consumption of zinc supplements.

结局指标

主要结局

Zinc level at different intervals. Zinc levels in serum increases gradually, reaches peak and declines.

时间窗: 0, 1st hr, 2nd hr, 3rd hr, 4th hr, 5th hr, 6th hr, 7th hr.

次要结局

  • Blood Pressure before and after supplementation of Yashada Bhasma.(0hr and after 7th Hr.)

研究者

发起方
Veda SM
申办方类型
Other [self]

研究点 (1)

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