CTRI/2022/07/043761进行中（未招募）未知
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 Chem0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 未知
- 状态
- 进行中（未招募）
- 发起方
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.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.
研究者
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