跳至主要内容
临床试验/CTRI/2023/12/060476
CTRI/2023/12/060476已完成Unknown

An Open-Label, Single Arm, Clinical Study to Evaluate the Safety of HORS-051511 in Healthy Adults - NII

Himalaya Wellness Company (HWC)0 个研究点目标入组 12 人开始时间: 待定最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
12

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

  • 1.Healthy adult subjects, both men and women within age group of 18 to 45 years.
  • 2.Subjects willing to sign an informed consent document.
  • 3.Subjects willing to adhere to protocol requirements throughout the study period.
  • 4.Subjects who have not participated in any clinical study in the past 30 days.
  • 5.Subjects who are willing to do moderate and vigorous physical activities at least 4 times a week as reported by the subjects. (Appendix I)

排除标准

  • 1.Women who are pregnant, nursing, or planning a pregnancy during study entry and through the duration of the study.
  • 2.Subjects with known allergies to any of the ingredients of the test product.
  • 3.Subject with clinically significant abnormal lab values detected at the time of screening as determined by the investigator.
  • 4.Subject who had a history of hypersensitivity to any packaged rehydration beverage.
  • 5.Subjects with clinically significant serious cardiovascular, cerebrovascular, respiratory, liver, renal disease, congenital or any other disorder as determined by the investigator.
  • 6.Subjects with clinically significant pre-existing systemic disease necessitating long-term medications as determined by the investigator.
  • 7.Subjects not willing to refrain from taking any other similar supplements during the study period.
  • 8.Subjects not willing to abstain from excessive intake of recreational products like tobacco/pan chewing, smoking, alcohol and any other as determined by the investigator during the study period.

研究者

发起方
Himalaya Wellness Company (HWC)

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