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
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