A single-arm clinical trial to evaluate the safety and efficacy of Mentacalm tablets in reducing stress and anxiety in adults.

Vedistry Pvt. Ltd.1 个研究点分布在 1 个国家目标入组 30 人开始时间: 2024年9月13日最近更新: 2024年9月2日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 30
试验地点: 1
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, a significant psychosocial stressor, is a primary contributor to the pathogenesis of various mental health disorders, including anxiety and depression. Its deleterious effects extends beyond emotional distress, impairing cognitive function, such as concentration and decision-making. The intricate relationship between stress, mental health, and cognitive function underscores the necessity for effective stress management strategies to mitigate these detrimental consequences and promote overall well-being. Moreover, the potential interplay between stress, nutrition, and cognitive health necessitates a comprehensive approach to address these interconnected factors. The prevalence of stress and anxiety has significantly increased in recent years, with approximately one-third of the population reporting symptoms. Mood and anxiety disorders, encompassing stress, anxiety, and depression, constitute a significant public health burden . Systematic reviews of longitudinal and cross-sectional data consistently demonstrate an inverse relationship between stress and quality of life. Additionally, research indicates that chronic psychological stress may accelerate the aging process. Pharmacological interventions are indicated for severe mental health conditions, while milder presentations often benefit from a multimodal approach integrating nutraceuticals and cognitive-behavioral therapy (CBT). This holistic strategy optimizes outcomes while mitigating the economic burden associated with psychotropic medications and overcome significant barriers to care.

Individuals with mental health diagnoses often encounter significant stigma and social discrimination, leading to reduced help-seeking behaviours. This manifests in avoidance of healthcare settings and limited engagement with mental health professionals, hindering therapeutic alliance and information disclosure. Non-adherence to prescribed psychotropic medications, particularly within public and academic environments, is a prevalent challenge. These factors underscore the urgent need for innovative therapeutic strategies to address the multifaceted barriers to mental health care. The convenience and established efficacy of traditional tablet formulations offer distinct advantages for medication adherence. Tablets provide a reliable and consistent method of drug delivery, contributing to optimal therapeutic outcomes. Mentacalm tablet containing ingredients which have the potential to calm the mind, reduce brain hyperactivity, and improve mood and anxiety. Within this compendium of noteworthy botanical agents, Bacopa monnieri and Convolvulus prostrates stands out as an herb with an extensive historical tradition and a multitude of purported health benefits, in the investigational product along with Withania somnifera, Celastrus paniculatus, Acorus calamus, Terminalia arjuna, Valeriana wallichii it could synergistically add potential to mitigate stress and related symptoms in a better way. While these ingredients show promise in preliminary research, further studies are needed to confirm their effectiveness at the dosages typically found in tablets. The current research aims at evaluating safety and efficacy of Mentacalm in management of stress and anxiety in adults.

研究设计

研究类型: Interventional
分配方式: Randomized
盲法: None

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 i.e, 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 greater than 180 mm Hg or diastolic blood pressure greater 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.