Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
NCT Number: NCT06568965
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Dyspepsia|Indigestion
Interventions: OTHER: De-stress & happy gut powder-U001|OTHER: De-Stress & Happy Gut powder-I001|OTHER: Placebo Powder 001
Sponsor: Herbolab India Pvt. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 81
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-09-05
Completion Date: 2024-12-28

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.

Primary Outcome Measures: 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 Outcome Measures: Safety of participant Assessed using adverse events, It is measure in terms of No. of events parameters., Screening, baseline, day 15, day 30, day 60|Safety of participant Assessed using treatment compliance and tolerability of investigational product, It is measure in terms of percentage, Screening, baseline, day 15, day 30, day 60|Systolic blood pressure difference from reference measurement (mmHg), Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg), Screening, baseline, day 15, day 30, day 60|Diastolic blood pressure difference from reference measurement (mmHg), Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg), Screening, baseline, day 15, day 30, day 60|Pulse rate difference from reference measurement (beats per minute), Assessed against standard clinical grade instrument: Finger-based pulse oximeter (beats per minute), Screening, baseline, day 15, day 30, day 60|Complete blood count, White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\] Red blood cell count \[Millions per microliter (million/uL)\], Screening and day 60|Serum Glutamic Pyruvic Transaminase (SGPT), Blood level of SGPT was measured. (U/L), Screening and day 60|Serum glutamic-oxaloacetic transaminase (SGOT), Blood level of SGOT was measured. (U/L), Screening and day 60|Creatinine difference from reference measurement (mg/dl), Blood levels of Creatinine was measured. (mg/dl), Screening and day 60