Status:
NOT_YET_RECRUITING
Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
Lead Sponsor:
Herbolab India Pvt. Ltd.
Conditions:
Stress
Dyspepsia
Eligibility:
All Genders
21-50 years
Phase:
NA
Brief Summary
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...
Detailed Description
This is a randomized, double-blind, placebo-controlled, parallel-arm, clinical trial of De-Stress \& Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults. In this study, m...
Eligibility Criteria
Inclusion
- Male and female participants aged 21-50 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 i.e. 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
- Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria
- 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
Exclusion
- Inability to perform any of the assessments required for endpoint analysis
- Known hypersensitivity to investigational products
- Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
- Advanced chronic illness that would impair follow-up or monitoring
- 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;
- Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male;
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- 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
- Have any other neurodegenerative diseases, mental illness or dementia
- Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant.
Key Trial Info
Start Date :
September 5 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 28 2024
Estimated Enrollment :
81 Patients enrolled
Trial Details
Trial ID
NCT06568965
Start Date
September 5 2024
End Date
December 28 2024
Last Update
August 23 2024
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