A Clinical Study of De-Stress & Chill Gummies in Reducing Stress
NCT Number: NCT06571071
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Anxiety
Interventions: OTHER: De-Stress and Chill Gummies-U001|OTHER: De-Stress and Chill Gummies-I001|OTHER: Placebo Gummies-001
Sponsor: Herbolab India Pvt. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 72
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 reduction of stress,anxiety and improving mood in adults. Adults experiencing chronic stress and anxiety often suffer from a reduced quality of life, marked by symptoms such as irritability, fatigue, and difficulty concentrating. By integrating these gummies into their daily routine, many report noticeable improvements in their emotional and mental state. These enhancements can manifest as increased energy levels, better sleep quality, and a more balanced mood, which collectively contribute to a more positive outlook on life.

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, day 60|Changes in Creatine kinase, Blood level of Creatine kinase was measured. (U/L), Screening, day 30, day 60|Changes in Lactate dehydrogenase(LDH), Blood level Lactate dehydrogenase of was measured. (U/L), Screening, day 30, day 60|Body Mass Index (BMI), Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703, Screening, day 30, day 60|Mental chatter 5-point scale, Grading will be assessed on a 5-point ordinal scale. Score assessment according to the following- 1-High mental chatter, 2-Moderate mental chatter, 3-Less but frequent mental chatter, 4-less and rare mental chatter, 5-no mental chatter, Screening, day 30, day 60|Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A), Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety.

Score as per below criteria: 0 = Not present, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Total score range of 0-56, where \<17 indicates mild severity 18-24 mild to moderate severity 25-30 moderate to severe., Screening, day 30, 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, 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, day 30, day 60|visual analogue scale, Visual analogue scale score- for evaluation of fatigue, nausea, palpitation, breathlessness A higher score (10) represents severe symptoms and a lower score (0) represents no symptoms., Screening, day 30, day 60|Changes in serum cortisol levels, The cortisol secretion will be evaluated by measuring morning serum cortisol levels., Screening, day 15, day 60|Change in serum serotonin levels, The serotonin secretion will be evaluated by measuring morning serum serotonin levels., Screening, day 30, day 45|Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ), The Modified Sleep Regularity and Medication Withdrawal Questionnaire (MSRMWQ) is a tool designed to assess changes in sleep patterns and the impact of medication withdrawal on sleep. Total score categories: Part I 00-10 = Poor sleep regularity 21-30 = Better sleep regularity 11-20 = Good sleep regularity 31-40 = Excellent sleep regularity Parameter-wise scoring by 4 point Linkert scale: Part II 0 = No symptom

1. = Resolved symptom
2. = Ongoing symptoms requiring no medical assistance
3. = Ongoing symptoms requiring medical assistance, After stopping treatment for 1 week (day 68)|Change in mood assessed using the Profile of Mood States (POMS), 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, day 15, day 30, day 60
Secondary Outcome Measures: Safety of participant Assessed using adverse events, It is measure in terms of No. of events, Screening, baseline, day 15, day 30, day 45, 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 45, 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 45, 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 45, 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 45, 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