A randomized, double-blind, placebo-controlled, parallel arm clinical trial of De-Stress and Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults.

Herbolab India Pvt Ltd2 个研究点分布在 1 个国家目标入组 81 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: 尚未招募
发起方
入组人数: 81
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 relieving stress and functional dyspepsia symptoms in adults for gut health. The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being. Improved digestive health leads to better nutrient absorption, which is essential for energy levels and immune function. Reduced stress levels contribute to better sleep quality, cognitive function, and emotional stability.

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 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.Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria 6.Participant should be suffering with at least 4 or more symptoms mentioned below and with a total symptom score of 20 or more based on a 7-point Likert scale (a) Upper abdominal fullness (b) Upper abdominal pain (c) Belching (d) Bloating (e) Early satiety (f) Nausea (g) Vomiting (h) Regurgitation (i) Heartburn (j) Loss of appetite.

排除标准

•1.Inability to perform any of the assessments required for endpoint analysis 2.Known hypersensitivity to investigational products 3.Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years 4.Advanced chronic illness that would impair follow-up or monitoring 5.Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment.
•Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management; 6.Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male; 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.Participants with current or past diagnoses of peptic ulcer disease, gastroesophageal reflux disorder (GERD), or irritable bowel syndrome (IBS), as well as those who have undergone surgery related to these conditions 9.Have any other neurodegenerative diseases, mental illness or dementia 10.Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant.