An interventional study of De-Stress & Snooze Gummies-U001 and De-Stress & Snooze Gummies-I001 in Stress, Insomnia and Quality of Life, sponsored by Herbolab India Pvt. Ltd.. Not yet recruiting. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Herbolab India Pvt. Ltd. · Not applicable, Interventional, and Supportive care
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.
A randomized, double-blind, placebo-controlled clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms, and overall quality of life.
More than 60 Participants will be randomized to either one of the following groups:
Group A, Group B, and Group C will involve 20 participants each group (1:1:1 ratio) will be advised to take Destress and snooze gummies - U001, Destress and snooze gummies - I001, and Placebo gummies-002, respectively two gummies in sequence daily, 30 minutes before bed, for 60 days. The treatment duration is of 60 days and the study duration is of 68 days. The efficacy of the investigational product will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening.
Assessments of changes in stress through PSS scores, serum serotonin, restorative sleep by RSQ-W score, under eye dark circles based on bespoke scale, and headache by VAS score will be conducted on screening, day 30 and day 60.
Changes in serum cortisol levels will be evaluated at screening, day 15, and day 60. Additionally, participants' sleep diaries will be assessed to determine the changes in total sleep time, sleep latency, number of awakenings, wake time after sleep onset, sleep efficiency (total sleep time/time in bed * 100), and levels of alertness and drowsiness and actigraphy assessment using Fitbit device to evaluate sleep efficiency (deep sleep, light sleep, and REM sleep duration, as well as overall sleep scores) which will be tracked for 10 individuals (3-4 subjects per group) at baseline, day 30, and day 60.
Changes in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) and the abbreviated Profile of Mood States (POMS-A) score to investigate mood changes and safety through complete blood count, liver function test, and kidney function test will be assessed at screening and day 60.
Changes in the modified sleep regularity and medication withdrawal questionnaire (MSRMWQ) score will be assessed after ceasing treatment for one week (day 68), telephonically.
Treatment compliance and tolerability will be assessed at day 30 and day 60, and safety of the investigational treatment in terms of adverse events will be assessed at baseline, day 15, day 45, and day 60. Changes in vital sign parameters will be assessed at screening, baseline, day 15, day 30, day 45 and day 60.
Exclusion Criteria:
Other: De-Stress & Snooze Gummies-U001
Other: De-Stress & Snooze Gummies-I001
Other: Placebo Gummies 002
Two gummies daily in sequence 30-45 minutes before bed for 60 days
Two gummies daily in sequence 30-45 minutes before bed for 60 days
Two gummies daily in sequence 30-45 minutes before bed for 60 days
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 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.
Time frame: 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).
Time frame: 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.
Time frame: 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).
Time frame: 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
Time frame: 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.
Time frame: Screening, day 15 and day 60
Change in serum serotonin levels
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline, day 30 and day 60
Safety of participant Assessed using adverse events
It is measured in terms of No. of events
Time frame: 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
Time frame: 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)
Time frame: Screening and day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Time frame: 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)
Time frame: Screening and day 60
Complete blood count
White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\] Red blood cell count \[Millions per microliter (million/uL)\]
Time frame: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Blood level of SGPT was measured. (U/L)
Time frame: Screening and day 60
serum glutamic-oxaloacetic transaminase (SGOT)
Blood level of SGOT was measured. (U/L)
Time frame: Screening and day 60
Creatinine
Creatinine difference from reference measurement (mg/dl)
Time frame: Screening and day 60
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Plan to share: No
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Herbolab India Pvt. Ltd.