A randomized, double-blind, placebo-controlled, parallel-arm clinical trial of interventional products in reducing stress and anxiety, and improving mood in adults.

Mane Kancor Ingredients Pvt. Ltd.3 个研究点分布在 1 个国家目标入组 150 人开始时间: 2025年3月11日最近更新: 2025年8月6日

试验速览

阶段: 不适用
状态: 已完成
发起方
入组人数: 150
试验地点: 3
主要终点: The efficacy endpoints of the study include assessment of

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

Stress responses are crucial for survival, enabling us to adapt to challenging situations. However, chronic stress can have detrimental effects on both physical and mental health. It is a significant public health concern, contributing to a wide range of health issues. Studies suggest that stress-related disorders are responsible for a substantial portion of primary care physician visits, estimated to be between 75% and 90% .

In today’s world, individuals are constantly exposed to stressors, making it difficult to avoid the impact of chronic stress. This increased exposure contributes to the rising incidence of stressrelated disorders such as depression, anxiety, and various neurodegenerative diseases. A systematic review conducted an integrative analysis of longitudinal and cross-sectional studies, revealing an inverse association between stress and quality of life. Furthermore, a separate review investigated the consequences of psychological stress on the aging process, concluding that it may impede healthy aging. Individuals with mental health diagnoses may experience stigma and social discomfort, leading to decreased help-seeking behaviours. This manifests as avoidance of healthcare professionals, staff, and service users. Additionally, it can hinder disclosure of information, limit question-asking and responding, and discourage complaints.

Non-adherence to prescribed medications, particularly in public settings like educational institutions (colleges) and workplaces, presents a significant challenge. Research has been continuing to find a better alternative. This calls for the need to develop newer therapeutic strategies. Despite advancements in therapies and medications, achieving optimal treatment outcomes for stress-related conditions remains a challenge. Limited access to and high cost of psychotropic medications for patients continues to be a significant barrier to effective treatment. Therefore, exploring strategies to modulate an individual’s stress response is crucial. Plant extracts offer a promising avenue for mitigating the detrimental effects of stress, potentially serving as complementary or alternative approaches to existing medications and therapies.

Investigational products containing ingredients like Rosemary (Rosemarinic acid and carnosic acid) and Ashwagandha (Withanolide aglycone and Withanolide glycosides) have the potential to calm the mind, reduce brain hyperactivity, and improve mood and anxiety. Rosemary and Ashwagandha possess well-documented ethnopharmacological and preclinical evidence supporting their potential anxiolytic, mood-enhancing, and cognitive-enhancing effects. Rosemary has demonstrated promising clinical effects on mood, learning, memory, pain, anxiety, and sleep. Ashwagandha, a renowned adaptogen, boasts a rich historical tradition and a wide array of purported health benefits, including stress reduction.

Given their individual and potentially synergistic mechanisms of action, a combination of these botanical agents may offer a more comprehensive and effective approach to mitigating stress,anxiety, and associated symptoms. While promising preclinical and limited clinical data exist, further rigorous investigations are warranted to establish the efficacy and safety of this botanical combination in managing stress, anxiety, and improving mood in adult populations.

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

•Participants meeting all the following criteria will be eligible for the study.
•Male and female participants aged 21 to 50 years both inclusive
•Suffering from self reported mild to moderate stress on the PSS scale score less than or equal to 26
•Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
•No severe anxiety and depression that is 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
•A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout study period
•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
•Willing to limit caffeine consumption while in the study.

排除标准

•Inability to perform any of the assessments required for endpoint analysis
•Shows signs of dementia such as caused by Alzheimers Disease Acquired Immuno Deficiency 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
•Participants currently using any nutraceutical allopathic or ayurvedic supplement for stress management
•Have any other neurodegenerative diseases or seizure disorder
•Known hypersensitivity to investigational products
•Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
•Pregnant or lactating women as well as women of childbearing potential who are not using contraception or intending to conceive during the study
•Sitting or resting systolic blood pressure greater than 180 mm Hg or diastolic blood pressure greater than 110mm Hg at screening
•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.