Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
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.
2 other identifiers
interventional
81
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2024
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 10, 2024
CompletedFirst Posted
Study publicly available on registry
August 23, 2024
CompletedStudy Start
First participant enrolled
September 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 28, 2024
CompletedAugust 23, 2024
August 1, 2024
3 months
August 10, 2024
August 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (9)
Perceived Stress Scale
The PSS-10 is widely used for measuring psychological distress. It contains 10 questions on a five-point scale from 0 to 4. The higher the score, the greater the feeling of stress. PSS-10 Scores ranging from 0-13 would be considered low stress. Scores ranging from 14-26 would be considered moderate stress. Scores ranging from 27-40 would be considered high perceived stress.
Screening, day 30 and day 60
Short Form of Nepean Dyspepsia Index (SF-NDI)
The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50. The total score gives an overall measure of the impact of dyspepsia on the individual, with higher scores indicating more severe symptoms or greater impairment in quality of life due to dyspepsia.
Screening, day 30 and day 60
COPE Questionnaire
Problem-Focused Coping: A high score indicates coping strategies that are aimed at changing the stressful situation. High scores are indicative of psychological strength, grit, a practical approach to problem solving and is predictive of positive outcomes. Emotion-Focused Coping: A high score indicates coping strategies that are aiming to regulate emotions associated with the stressful situation. High or low scores are not uniformly associated with psychological health or ill health, but can be used to inform a wider formulation of the respondent's coping styles. Avoidant Coping: A high score indicates physical or cognitive efforts to disengage from the stressor. Low scores are typically indicative of adaptive coping.
Screening, day 30 and day 60
Gastrointestinal Symptom Rating Scale (GSRS)
The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms.
Screening, day 30 and day 60
Time required to relief pain for acid reflux flare/heartburn symptoms
Participants should consume the investigational product during an acid reflux flare-up or heartburn and record the time taken to achieve relief. The time will be recorded.
Screening, day 30 and day 60
STAI (State-Trait Anxiety Inventory)
STAI: State-Trait-Anxiety-Inventory-Score This test consists of 20 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). The sum score has a range from 20-80. Its interpretation with respective score are discussed below: mild anxiety (20 to 39); moderate anxiety (40 to 59); intense anxiety (60 to 80).
Screening and day 60
Profile of Mood State (POMS) questionnaire
The Profile of Mood States (POMS) is a widely used instrument that measures mood using a 40 item questionnaire with each item rated using a response scale of five categories ranging from "not at all" to "Extremely". Higher score indicates worse mood. Total POMS score categories and stress inference: 0-40 = A little; 81-120= Quite a lot; 41-80= Moderately; 121-160= Extremely.
Screening and day 60
Change in serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels
Screening, day 15 and day 60
Changes in 7 point Likert scale scores
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) 1 - No discomfort at all, 2- Minor discomfort, 3- Mild discomfort, 4- Moderate discomfort, 5- Moderately severe discomfort, 6- Severe discomfort, 7- Very severe discomfort
Screening, day 15, 30 and day 60
Secondary Outcomes (9)
Safety of participant Assessed using adverse events
Screening, baseline, day 15, day 30, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
Screening, baseline, day 15, day 30, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Screening, baseline, day 15, day 30, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Screening, baseline, day 15, day 30, day 60
Pulse rate difference from reference measurement (beats per minute)
Screening, baseline, day 15, day 30, day 60
- +4 more secondary outcomes
Study Arms (3)
De-stress & happy gut powder-U001
EXPERIMENTALDe-Stress & Happy Gut powder-I001
EXPERIMENTALPlacebo Powder 001
OTHERInterventions
Take one sachet daily, 30 minutes before breakfast, for 60 days
Take one sachet daily, 30 minutes before breakfast, for 60 days
Take one sachet daily, 30 minutes before breakfast, for 60 days
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr. Ramshyam Agarwal, MBBS, DNB
Lokmanya Medical Research Centre and Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Masking Details
- Double blind
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 10, 2024
First Posted
August 23, 2024
Study Start
September 5, 2024
Primary Completion
November 20, 2024
Study Completion
December 28, 2024
Last Updated
August 23, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share