Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.

NCT ID: NCT06568965

Last Updated: 2024-08-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-05
• Study Completion Date: 2024-12-28

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 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.

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, more than 81 participants will be enrolled in a 1:1:1 ratio into three groups: Group A (De-stress & Happy Gut Powder-U001), Group B (De-stress & Happy Gut Powder-I001), and Group C (Placebo Powder 001). Each participant will take one sachet daily, 30 minutes before breakfast, for 60 days. The efficacy of the investigational products will be compared between the groups.

Concomitant diseases/medication assessment will be performed on screening. The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale (PSS) score, Nepean Dyspepsia Index (NDI), changes in serum cortisol levels, changes in the COPE Questionnaire (a. Positive Subscale, b. Denial Subscale) score, assessing gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score will be assessed at screening, day 30, and day 60.

Changes in the State-Trait Anxiety Inventory (STAI) score, changes in the Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance, b. Depression) will be assessed at screening and day 60.

Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia (Upper abdominal fullness, Pain, Belching, Bloating, Early satiety, Nausea, Vomiting, Regurgitation, Heartburn, Loss of appetite, cravings for junk food) will be assessed at screening, day 15, 30, and day 60.

Changes in gut microbiota at screening and day 60; and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn will be assessed at baseline, day 15, 30, and day 60.

Treatment compliance, tolerability of investigational products will be assessed at day 30 and day 60. Safety of the investigational treatment in terms of adverse events (AEs), and serious adverse events (SAEs), will be assessed at baseline, day 15, day 30, and day 60.

Assessment of changes in vital sign parameters will be done from screening to end of the study (Day 60).

Conditions

Stress; Dyspepsia; Indigestion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

De-stress & happy gut powder-U001

Group Type: EXPERIMENTAL

De-stress & happy gut powder-U001

Intervention Type: OTHER

Take one sachet daily, 30 minutes before breakfast, for 60 days

De-Stress & Happy Gut powder-I001

Group Type: EXPERIMENTAL

De-Stress & Happy Gut powder-I001

Intervention Type: OTHER

Take one sachet daily, 30 minutes before breakfast, for 60 days

Placebo Powder 001

Group Type: OTHER

Placebo Powder 001

Intervention Type: OTHER

Take one sachet daily, 30 minutes before breakfast, for 60 days

Interventions

De-stress & happy gut powder-U001

Take one sachet daily, 30 minutes before breakfast, for 60 days

Intervention Type: OTHER

De-Stress & Happy Gut powder-I001

Take one sachet daily, 30 minutes before breakfast, for 60 days

Intervention Type: OTHER

Placebo Powder 001

Take one sachet daily, 30 minutes before breakfast, for 60 days

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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 Patients' 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

Exclusion Criteria

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.

• Minimum Eligible Age: 21 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Herbolab India Pvt. Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Ramshyam Agarwal, MBBS, DNB

Role: PRINCIPAL_INVESTIGATOR

Lokmanya Medical Research Centre and Hospital

Central Contacts

Dr. Kriti Soni, PhD

Role: CONTACT

kriti.soni@rpsg.in

+91 9871018383

Dr. Gayatri Ganu, PhD

Role: CONTACT

drgayatri@mprex.in

+91 8554912644

Other Identifiers

CTRI/2024/07/071248

Identifier Type: REGISTRY

Identifier Source: secondary_id

MHC/CT/24-25/015

Identifier Type: -

Identifier Source: org_study_id