A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder

NCT06571331 | Not Yet Recruiting DMC

• 2 other identifiers: MHC/CT/24-25/019CTRI/2024/07/071253
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Insomnia; Quality of Life

Keywords

Stress; Insomnia; Quality of Life

Outcome Measures

Primary Outcomes (11)

• 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 Outcomes (9)

• Safety of participant Assessed using adverse events

  Screening, baseline, day 15, day 30, day 45, day 60

• Safety of participant Assessed using treatment compliance and tolerability of investigational product

  Screening, baseline, day 15, day 30, day 45, day 60

• Systolic blood pressure difference from reference measurement (mmHg)

  Screening and day 60

• Diastolic blood pressure difference from reference measurement (mmHg)

  Screening and day 60

• Pulse rate difference from reference measurement (beats per minute)

  Screening and day 60

Study Arms (3)

De-Stress & Snooze Gummies-U001

EXPERIMENTAL

Other: De-Stress & Snooze Gummies-U001

De-Stress & Snooze Gummies-I001

EXPERIMENTAL

Other: De-Stress & Snooze Gummies-I001

Placebo Gummies 002

PLACEBO COMPARATOR

Other: Placebo Gummies 002

Interventions

De-Stress & Snooze Gummies-U001 OTHER

Two gummies daily in sequence 30-45 minutes before bed for 60 days

De-Stress & Snooze Gummies-U001

De-Stress & Snooze Gummies-I001 OTHER

Two gummies daily in sequence 30-45 minutes before bed for 60 days

De-Stress & Snooze Gummies-I001

Placebo Gummies 002 OTHER

Two gummies daily in sequence 30-45 minutes before bed for 60 days

Placebo Gummies 002

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate
• Participants with a diagnosis of mild or moderate depression patient's health questionnaire PHQ-9 score of less than or equal to 14
• Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10.

You may not qualify if:

• 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
• History of substance abuse or dependence
• History or current evidence of a clinically significant cardiovascular disorder at pre-study visit
• Taking certain prohibited medications
• Consumption of greater than 10 cigarettes a day
• Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study
• Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent
• Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management
• Known hypersensitivity to any ingredients of product
• Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
• 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.

Sponsors & Collaborators

• Herbolab India Pvt. Ltd.: lead

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Study Officials

• Dr. Ramshyam Agarwal, MBBS, DNB

  Lokmanya Medical Research Centre and Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Kriti Soni, PhD

CONTACT

+91 9871018383; kriti.soni@rpsg.in

Dr. Gayatri Ganu, PhD

CONTACT

+91 8554912644; drgayatri@mprex.in

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Double blind
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Randomized, Double Blind, Parallel Group, Placebo-Controlled Trial

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 26, 2024
• Study Start: September 5, 2024
• Primary Completion: November 25, 2024
• Study Completion: December 28, 2024
• Last Updated: August 26, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share