An Open-Label, Single Arm, Clinical Study to Evaluate the Safety of HORS-051511 in Healthy Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Evaluation of safety of HORS-051511 in healthy adults by the following assessments:
研究概览
简要总结
PROTOCOL TITLE: An Open-Label, Single Arm, Clinical Study to Evaluate the Safety of HORS-051511 in Healthy Adults.
PROTOCOL NUMBER/VERSION: HWC/MSCD/FF/039/2023, Version No: 1.0, Dated 06th November 2023.
This is a single-arm, open-label clinical trial designed to evaluate the safety of HORS-051511, which is available in three flavors (Apple, Pomegranate, and Orange), specifically in healthy adults. The study aims to enroll a total of 12 subjects, with all participants in a single arm. The primary objective is to assess the safety of the test product during a seven-day usage period. The study will involve assessments on day 1 (baseline) and day 7 (+1 day) to monitor various aspects, including general physical health, laboratory values, adverse events, and medication use. The test product, provided by Himalaya Wellness Company, is a functional beverage comprising essential electrolytes, vitamins, and natural fruit ingredients, with the purpose of replenishing electrolytes, providing energy, combating fatigue, reducing oxidative stress, and aiding in rehydration. Participation in the study is voluntary, and subjects will be selected based on eligibility criteria. The study results will contribute to ensuring the product’s safety for consumers and may support further product development
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
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.
- •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.
结局指标
主要结局
Evaluation of safety of HORS-051511 in healthy adults by the following assessments:
时间窗: 1 Day and 7 Day
1.General Physical Examinations
时间窗: 1 Day and 7 Day
2.Laboratory Examinations.
时间窗: 1 Day and 7 Day
次要结局
- Adverse events (AE): AEs/SAEs will be continuously monitored throughout the duration of the study(7 Days)
研究者
Dr Rajendra Narayan Sharma
TrialGuna Private Limited