A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
NCT Number: NCT06571331
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Stress|Insomnia|Quality of Life
Interventions: OTHER: De-Stress & Snooze Gummies-U001|OTHER: De-Stress & Snooze Gummies-I001|OTHER: Placebo Gummies 002
Sponsor: Herbolab India Pvt. Ltd.
Sex: ALL
Age: ADULT
Enrollment: 60
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 management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a good night's sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind.

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|Restorative Sleep Questionnaire Weekly Version (RSQ-W), Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly). It is a 9 item scale questioner. Scoring interpretation: A total score is calculated as the average of the questionnaire items. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep. To convert the average score to a 0-100 scale, the following transformation is used: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1} \*25., Screening, day 30 and day 60|Number of Participants Who Showed Improvement in Under Eye Dark Circle, The interpretation will be like No Dark Circles (No visible dark circles under the eyes); 1: Minimal Dark Circles (Slight discoloration or shadow, barely noticeable); 2: Mild Dark Circles (Noticeable darkening, but not prominent or severe); 3: Moderate Dark Circles (Prominent dark circles with moderate intensity); 4: Severe Dark Circles (Intense and distinct dark circles, may appear blueish-black); 5: Blueish Black Dark Circles (Extreme and prominent dark circles with a deep blue or black hue)., Screening, day 30 and 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 and day 60|Change in Sleep Efficiency, Sleep efficiency will be calculated using information by actigraphy from Fitbit device.

Sleep efficiency in terms of - Deep sleep, light sleep, REM sleep duration and overall sleep score by actigraphy (Fitbit device) for 10 subjects (3-4 subjects in each group)., Baseline, day 30 ad day 60|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, Score after stopping treatment for 1 week (day 68)|Changes in serum cortisol levels, The cortisol secretion will be evaluated by measuring morning serum cortisol levels., Screening, day 15 and day 60|Change in serum serotonin levels, The serotonin secretion will be evaluated by measuring morning serum serotonin levels., Screening, day 30 and day 45|Change in FOSQ-10 score Profile of Mood State (POMS) questionnaire, Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 10-40 with higher scores indicating higher functional., Screening and day 28|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 28|Changes in outcomes from participant sleep diary, Sleep diary parameters - total sleep time in minutes, sleep latency in minutes, number of awakenings in numbers, wake time after sleep onset in minutes, sleep efficiency in percentage (Total sleep time/ time in bed\*100), alertness and drowsiness will be recorded using 5-point scale., Baseline, day 30 and day 60
Secondary Outcome Measures: Safety of participant Assessed using adverse events, It is measured 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 and day 60|Diastolic blood pressure difference from reference measurement (mmHg), Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg), Screening and 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 and 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, Creatinine difference from reference measurement (mg/dl), Screening and day 60