Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-50
SponsorHerbolab India Pvt. Ltd.
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
De-stress & happy gut powder-U001
Other interventionTake one sachet daily, 30 minutes before breakfast, for 60 days
De-Stress & Happy Gut powder-I001
Other interventionTake one sachet daily, 30 minutes before breakfast, for 60 days
Placebo Powder 001
Other interventionTake one sachet daily, 30 minutes before breakfast, for 60 days
Treatment groups
81 Participants
are divided into 3 treatment groupsGroup A: De-stress & happy gut powder-U001Experimental treatment 1 intervention
Group B: De-Stress & Happy Gut powder-I001Experimental treatment 1 intervention
Group C: Placebo Powder 001Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Screening, day 30 and day 602
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.
Time frame
Screening, day 30 and day 603
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.
Time frame
Screening, day 30 and day 604
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.
Time frame
Screening, day 30 and day 60Secondary outcomes
1
Safety of participant Assessed using adverse events
It is measure in terms of No. of events parameters.
Time frame
Screening, baseline, day 15, day 30, day 602
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Time frame
Screening, baseline, day 15, day 30, day 603
Systolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame
Screening, baseline, day 15, day 30, day 604
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame
Screening, baseline, day 15, day 30, day 60Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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