A Clinical Study of De-Stress & Chill Gummies in Reducing Stress

A Randomized, Double Blind, Placebo-controlled, Parallel Arm Clinical Trial of De-Stress & Chill Gummies in Reducing Stress and Anxiety, and Improving Mood in Adults

The current study focuses on clinical validation of efficacy of nutraceutical product in reduction of stress,anxiety and improving mood in adults. Adults experiencing chronic stress and anxiety often suffer from a reduced quality of life, marked by symptoms such as irritability, fatigue, and difficulty concentrating. By integrating these gummies into their daily routine, many report noticeable improvements in their emotional and mental state. These enhancements can manifest as increased energy levels, better sleep quality, and a more balanced mood, which collectively contribute to a more positive outlook on life.

Study Overview

• Status: Not yet recruiting
• Conditions: Stress; Anxiety
• Intervention / Treatment: Other: De-Stress and Chill Gummies-U001; Other: De-Stress and Chill Gummies-I001; Other: Placebo Gummies-001

Detailed Description

This is a randomized, double-blind, parallel-arm, comparative, multicenter, placebo-controlled, clinical trial of De-Stress and Chill Gummies in reducing stress and anxiety, and improving mood in adults.

In this study, more than 72 participants will be enrolled and randomized into one of the following groups to achieve at least 72 completers (at least 24 participants in each group): Group A: De-Stress and Chill Gummies-U001, Group B: De-Stress and Chill Gummies-I001, and Group C: Placebo Gummies-001, in a 1:1:1 ratio. The study duration is 68 days. The efficacy of the investigational products will be compared between the groups.

Concomitant diseases/medication assessment will be performed at screening.

Assessment of changes in perceived stress scale (PSS) score, LDH and creatine kinase levels, body weight and BMI, mental chatter score using 5-point scale, Hamilton Anxiety Rating Scale (HAM-A) score, COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, visual analogue scale score- for evaluation of fatigue, nausea, palpitation, breathlessness, will be done at screening, day 30 and day 60. Assessment of changes in serum cortisol levels will be done at screening, day 15 and day 60. Assessment of changes in serotonin levels will be done at screening, day 30 and day 45. Assessment of changes in Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression) will be done at screening, day 15, day 30, and day 60. Assessment of modified sleep regularity and medication withdrawal questionnaire (MSRMWQ) score after stopping treatment for 1 week (day 68).

Assessment of changes in vital sign parameters will be done at baseline, Day 15, Day 30, Day 45, and Day 60. Assessment of changes in complete blood count, liver function test and kidney function test at screening and Day 60. Safety of the investigational treatment in terms of adverse events (AEs), and serious adverse events (SAEs) will be assessed at baseline, Day 15, Day 30, Day 45 and Day 60. Treatment compliance and tolerability will be assessed at Day 30 and Day 60.

• Study Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr. Kriti Soni, PhD; Phone Number: +91 9871018383; Email: kriti.soni@rpsg.in
• Study Contact Backup: Name: Dr. Gayatri Ganu, PhD; Phone Number: +91 8554912644; Email: drgayatri@mprex.in

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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. No severe anxiety and depression i.e. Generalized anxiety disorder GAD score less than or equal to 10 and Patients' health questionnaire-9 PHQ-9 score less than or equal to 14
5. A female participant who is of reproductive potential has a negative pregnancy test and agrees to use contraception throughout the study period 6 No history of substance use disorder other than the use of nicotine and recreational use of alcohol not having used for the last 14 days and consenting not to use the same during the period of the trial

7. Willing to limit caffeine consumption while in the study.

Exclusion Criteria:

1. Inability to perform any of the assessments required for endpoint analysis
2. Shows signs of dementia, such as caused by Alzheimer's Disease, acquired immunodeficiency syndrome (AIDS), Creutzfeldt-Jakob disease (CJD), Lewy Bodies dementia (LBD), Cerebrovascular dementia (CVD), Progressive Supranuclear Palsy (PSP), multiple cerebral infarctions, or normal pressure hydrocephalus (NPH)
3. Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
4. Have any other neurodegenerative diseases or seizure disorder
5. Known hypersensitivity to investigational products
6. Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
7. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
8. Sitting or resting systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg at screening
9. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within the last 5 years
10. Serious illness or any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the participant or preclude the successful completion of the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: De-Stress and Chill Gummies-U001	Other: De-Stress and Chill Gummies-U001; Two gummies in sequence daily after meal for 60 days
Experimental: De-Stress and Chill Gummies-I001	Other: De-Stress and Chill Gummies-I001; Two gummies in sequence daily after meal for 60 days
Placebo Comparator: Placebo Gummies-001	Other: Placebo Gummies-001; Two gummies in sequence daily after meal for 60 days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, day 60
Changes in Creatine kinase	Blood level of Creatine kinase was measured. (U/L)	Screening, day 30, day 60
Changes in Lactate dehydrogenase(LDH)	Blood level Lactate dehydrogenase of was measured. (U/L)	Screening, day 30, day 60
Body Mass Index (BMI)	Body Mass Index (BMI) will be calculated using the standard formula from participants' height and weight. BMI = (Weight in Pounds / (Height in inches x Height in inches)) x 703	Screening, day 30, day 60
Mental chatter 5-point scale	Grading will be assessed on a 5-point ordinal scale. Score assessment according to the following- 1-High mental chatter, 2-Moderate mental chatter, 3-Less but frequent mental chatter, 4-less and rare mental chatter, 5-no mental chatter	Screening, day 30, day 60
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A)	Participants will be interviewed by mental health professionals using the clinically validated Hamilton Anxiety Rating Scale, which has a score range of 0 to 56, where higher scores are associated with higher severity anxiety. Score as per below criteria: 0 = Not present, 1 = Mild, 2 = Moderate, 3 = Severe, 4 = Very severe. Total score range of 0-56, where <17 indicates mild severity 18-24 mild to moderate severity 25-30 moderate to severe.	Screening, day 30, day 60
COPE Questionnaire	Problem-Focused Coping: A high score indicates coping strategies that are aimed at changing the stressful situation. High scores are indicative of psychological strength, grit, a practical approach to problem solving and is predictive of positive outcomes. Emotion-Focused Coping: A high score indicates coping strategies that are aiming to regulate emotions associated with the stressful situation. High or low scores are not uniformly associated with psychological health or ill health, but can be used to inform a wider formulation of the respondent's coping styles. Avoidant Coping: A high score indicates physical or cognitive efforts to disengage from the stressor. Low scores are typically indicative of adaptive coping.	Screening, day 30, day 60
STAI (State-Trait Anxiety Inventory)	STAI: State-Trait-Anxiety-Inventory-Score This test consists of 20 items and assesses the current state of anxiety in relation to the current situation in which the patient is to the current situation in which the patient finds herself (State Anxiety) and the general anxiety state existing state of anxiety, which represents a part of her personality (Trait Anxiety). The sum score has a range from 20-80. Its interpretation with respective score are discussed below: mild anxiety (20 to 39); moderate anxiety (40 to 59); intense anxiety (60 to 80).	Screening, day 30, 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, day 60
Changes in serum cortisol levels	The cortisol secretion will be evaluated by measuring morning serum cortisol levels.	Screening, day 15, day 60
Change in serum serotonin levels	The serotonin secretion will be evaluated by measuring morning serum serotonin levels.	Screening, day 30, day 45
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; = Resolved symptom; = Ongoing symptoms requiring no medical assistance; = Ongoing symptoms requiring medical assistance	After stopping treatment for 1 week (day 68)
Change in mood assessed using the Profile of Mood States (POMS)	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, day 15, day 30, day 60

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Creatinine difference from reference measurement (mg/dl)	Blood levels of Creatinine was measured. (mg/dl)	Screening and 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
serum glutamic-oxaloacetic transaminase (SGOT)	Blood level of SGOT was measured. (U/L)	Screening and day 60
Safety of participant Assessed using adverse events	It is measure in terms of No. of events	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, baseline, day 15, day 30, day 45, day 60
Diastolic blood pressure difference from reference measurement (mmHg)	Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)	Screening, baseline, day 15, day 30, day 45, 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, baseline, day 15, day 30, day 45, day 60

Collaborators and Investigators

• Sponsor: Herbolab India Pvt. Ltd.
• Investigators: Principal Investigator: Dr. Ramshyam Agarwal, MBBS, DNB, Lokmanya Medical Research Centre and Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): September 5, 2024
• Primary Completion (Estimated): November 25, 2024
• Study Completion (Estimated): December 28, 2024

Study Registration Dates

• First Submitted: August 10, 2024
• First Submitted That Met QC Criteria: August 22, 2024
• First Posted (Actual): August 26, 2024

Study Record Updates

• Last Update Posted (Actual): August 26, 2024
• Last Update Submitted That Met QC Criteria: August 22, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: Anxiety; stress
• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: MHC/CT/24-25/016; CTRI/2024/07/071254 (Registry Identifier: Clinical trial registry of India)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No