A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
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 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.
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
Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR
Disqualifiers
Difficulty sleeping due to a medical condition
History of a neurological disorder
History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication
On-going depression and generalized anxiety disorder diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales
Trial design
Design model
Parallel
Treatments tested in this trial
De-Stress & Snooze Gummies-U001
Other interventionTwo gummies daily in sequence 30-45 minutes before bed for 60 days
De-Stress & Snooze Gummies-I001
Other interventionTwo gummies daily in sequence 30-45 minutes before bed for 60 days
Placebo Gummies 002
Other interventionTwo gummies daily in sequence 30-45 minutes before bed for 60 days
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: De-Stress & Snooze Gummies-U001Experimental treatment 1 intervention
Group B: De-Stress & Snooze Gummies-I001Experimental treatment 1 intervention
Group C: Placebo Gummies 002Placebo comparator 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
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 603
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 604
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 60Secondary outcomes
1
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 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 45, 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 and 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 and day 60Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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