Clinical trial NCT06571331: A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
Official title: A Randomized, Double Blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress and Snooze Gummies in Reducing Stress, Insomnia Disorder, Associated Symptoms and Overall Quality of Life
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Insomnia
Quality of Life
Keywords: Stress
Insomnia
Quality of Life
Lead sponsor: Herbolab India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double Blind, Parallel Group, Placebo-Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. Male and female participants aged 21-50 years both inclusive
2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
3. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
4. Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR
5. Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate
6. Participants with a diagnosis of mild or moderate depression patient's health questionnaire PHQ-9 score of less than or equal to 14
7. Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10.

Exclusion Criteria:

1. Difficulty sleeping due to a medical condition
2. History of a neurological disorder
3. History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication
4. 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
5. History of substance abuse or dependence
6. History or current evidence of a clinically significant cardiovascular disorder at pre-study visit
7. Taking certain prohibited medications
8. Consumption of greater than 10 cigarettes a day
9. Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study
10. Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent
11. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management
12. Known hypersensitivity to any ingredients of product
13. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
14. Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his her participation in and completion of the protocol.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Screening, day 30 and day 60
measure: Restorative Sleep Questionnaire Weekly Version (RSQ-W)
timeFrame: Screening, day 30 and day 60
measure: Number of Participants Who Showed Improvement in Under Eye Dark Circle
timeFrame: Screening, day 30 and day 60
measure: visual analogue scale
timeFrame: Screening, day 30 and day 60
measure: Change in Sleep Efficiency
timeFrame: Baseline, day 30 ad day 60
measure: Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
timeFrame: Score after stopping treatment for 1 week (day 68)
measure: Changes in serum cortisol levels
timeFrame: Screening, day 15 and day 60
measure: Change in serum serotonin levels
timeFrame: Screening, day 30 and day 45
measure: Change in FOSQ-10 score Profile of Mood State (POMS) questionnaire
timeFrame: Screening and day 28
measure: Profile of Mood State (POMS) questionnaire
timeFrame: Screening and day 28
measure: Changes in outcomes from participant sleep diary
timeFrame: Baseline, day 30 and day 60
Secondary outcomes:
measure: Safety of participant Assessed using adverse events
timeFrame: Screening, baseline, day 15, day 30, day 45, day 60
measure: Safety of participant Assessed using treatment compliance and tolerability of investigational product
timeFrame: Screening, baseline, day 15, day 30, day 45, day 60
measure: Systolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening and day 60
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening and day 60
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Screening and day 60
measure: Complete blood count
timeFrame: Screening and day 60
measure: Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Screening and day 60
measure: serum glutamic-oxaloacetic transaminase (SGOT)
timeFrame: Screening and day 60
measure: Creatinine
timeFrame: Screening and day 60
Other outcomes:
Locations:
Study officials:
affiliation: Lokmanya Medical Research Centre and Hospital
name: Dr. Ramshyam Agarwal, MBBS, DNB
role: PRINCIPAL_INVESTIGATOR
References: