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

Herbolab India Pvt Ltd2 个研究点分布在 1 个国家目标入组 72 人开始时间: 2024年8月6日最近更新: 2025年1月17日

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 72
试验地点: 2
主要终点: Primary outcomes are as follows-

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The current study focuses on clinical validation of efficacy of nutraceutical product in reduction of stress,anxiety and improving mood in adults. Adults experiencing chronic stress and anxiety often suffer from a reduced quality of life, marked by symptoms such as irritability, fatigue, and difficulty concentrating. By integrating these gummies into their daily routine, many report noticeable improvements in their emotional and mental state. These enhancements can manifest as increased energy levels, better sleep quality, and a more balanced mood, which collectively contribute to a more positive outlook on life.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: Participant and Investigator Blinded

入排标准

年龄范围: 21.00 Year(s) 至 50.00 Year(s)（—）
性别: All

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 Patientsâ€™ 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 Alzheimerâ€™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.