Clinical trial NCT06568965: Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
Official title: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Dyspepsia
Indigestion
Keywords: stress
Dyspepsia
Indigestion
Lead sponsor: Herbolab India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-23
Enrollment: 81
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double blind, Parallel Group, Placebo Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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).

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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Screening, day 30 and day 60
measure: Short Form of Nepean Dyspepsia Index (SF-NDI)
timeFrame: Screening, day 30 and day 60
measure: COPE Questionnaire
timeFrame: Screening, day 30 and day 60
measure: Gastrointestinal Symptom Rating Scale (GSRS)
timeFrame: Screening, day 30 and day 60
measure: Time required to relief pain for acid reflux flare/heartburn symptoms
timeFrame: Screening, day 30 and day 60
measure: STAI (State-Trait Anxiety Inventory)
timeFrame: Screening and day 60
measure: Profile of Mood State (POMS) questionnaire
timeFrame: Screening and day 60
measure: Change in serum cortisol levels
timeFrame: Screening, day 15 and day 60
measure: Changes in 7 point Likert scale scores
timeFrame: Screening, day 15, 30 and day 60
Secondary outcomes:
measure: Safety of participant Assessed using adverse events
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Safety of participant Assessed using treatment compliance and tolerability of investigational product
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Systolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Complete blood count
timeFrame: Screening and day 60
measure: Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Screening and day 60
measure: Serum glutamic-oxaloacetic transaminase (SGOT)
timeFrame: Screening and day 60
measure: Creatinine difference from reference measurement (mg/dl)
timeFrame: Screening and day 60
Other outcomes:
Locations:
Study officials:
affiliation: Lokmanya Medical Research Centre and Hospital
name: Dr. Ramshyam Agarwal, MBBS, DNB
role: PRINCIPAL_INVESTIGATOR
References: