CTRI/2024/07/071254尚未招募2 期
A randomized, double blind, placebo-controlled, parallel arm clinical trial of De-Stress and Chill Gummies in reducing stress and anxiety, and improving mood in adults - NI
Herbolab India Pvt Ltd0 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
- 2 期
- 状态
- 尚未招募
- 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 participants aged 21-50 years both inclusive 2.Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26 3.Participants willing to participate in clinical trials and who have read understood and signed the informed consent form 4.No severe anxiety and depression ie Generalized anxiety disorder GAD score less than or equal to 10 and Patients’ health questionnaire-9 PHQ-9 score less than or equal to 14 5.A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period 6.No history of substance use disorder other than use of nicotine and recreational use of alcohol not having used for the last 14 days and consenting not to use the same during the period of the trial 7.Willing to limit caffeine consumption while in the study.
排除标准
- •1.Inability to perform any of the assessments required for endpoint analysis
- •2.Shows signs of dementia, such as caused by Alzheimer’s Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH)
- •3.Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
- •4.Have any other neurodegenerative diseases or seizure disorder
- •5.Known hypersensitivity to investigational products
- •6.Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
- •7.Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- •8.Sitting or resting systolic blood pressure more than 180 mm Hg or diastolic blood pressure more than 110 mm Hg at screening
- •9.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
- •10.Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.
研究者
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