CTRI/2022/07/043761进行中（未招募）不适用
A Randomized, Double Blind, Parallel, Placebo Controlled Study to evaluate the Safety and Efficacy of KaraCalm - a dietary supplement to manage stress and improve sleep in adults
Green Chem1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年7月13日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from baseline - Sleep analysis by using Acti Watch
研究概览
简要总结
Thisis a randomized, placebo controlled double blind clinical study to evaluate theSafety and efficacy of a dietary supplement (KaraCalm) - to manage Stress andimprove Sleep in adults. Allsubjects will receive either Test or Reference product for a period of 56 days.The efficacy parameters will be analyzed on Baseline, Day 14, Day 28 and Day 56.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 54.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and Female healthy adult subjects ranging in age from 18 to 54 years.
- •2.Adults Subjects willing to provide a written Informed Consent 3.Free of psychiatric conditions other than mild stress 4.Could read and write English.
排除标准
- •1.Subjects with insomnia, sleep disorders, or chronic stress 2.Chronic alcoholics (more than 2 standard pegs / day) 3.Subjects with known Hypertension and other diseases of the cardiovascular system 4.Subjects with known Liver diseases, Kidney diseases, Psychiatric diseases, Epilepsy and/or with any other relevant diseases 5.Subjects with the intention of non-compliance to the study-protocol 6.Subject participating in another clinical trial or has received any IP within 90 days prior to Visit 1 (Screening).
- •7.Retraction of the written informed consent 8.Subjects currently taking medications other than oral contraceptive pill 9.Participants on hepatotoxic medications like antitubercular medication, antiviral medication, paracetamol etc.
- •10.Pregnant, attempting to conceive, or lactating women 11.Individuals with acute narrow-angle glaucoma, prostate hypertrophy, cardiovascular, endocrine or renal disease, or another chronic disease that could affect stress/anxiety or restrict normal, daily function were also ineligible to participate in the study.
- •12.Individuals who currently, or in the past 6 months, suffered from any diagnosable mental-health disorder (as assessed by the Mini International Neuropsychiatric Interview 6.0) or were taking a psychotropic medication or other herbal preparation were also excluded from participating in the study.
结局指标
主要结局
Change from baseline - Sleep analysis by using Acti Watch
时间窗: Baseline, Day 14 and Day 56
次要结局
- To assess the Safety and Tolerability of IP(Baseline and Day 56)
- Change from baseline to the end of the study in Perceived Stress Scale(Screening, Baseline, Day 14, 28, & 56)
- Change from baseline to the end of the study in Athens Insomnia Scale(Screening, Baseline, Day 14, 28, & 56)
- Change from baseline to the end of the study in Serum Cortisol(Baseline, Day 14 and Day 56)
- Change from baseline to the end of the study in Hs CRP(Baseline, Day 14 and Day 56)
研究者
研究点 (1)
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