Clinical trial NCT06571071: A Clinical Study of De-Stress & Chill Gummies in Reducing Stress
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Stress
Anxiety
Keywords: stress
Anxiety
Lead sponsor: Herbolab India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 72
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 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.

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.

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. 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.

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Screening, day 30, day 60
measure: Changes in Creatine kinase
timeFrame: Screening, day 30, day 60
measure: Changes in Lactate dehydrogenase(LDH)
timeFrame: Screening, day 30, day 60
measure: Body Mass Index (BMI)
timeFrame: Screening, day 30, day 60
measure: Mental chatter 5-point scale
timeFrame: Screening, day 30, day 60
measure: Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A)
timeFrame: Screening, day 30, day 60
measure: COPE Questionnaire
timeFrame: Screening, day 30, day 60
measure: STAI (State-Trait Anxiety Inventory)
timeFrame: Screening, day 30, day 60
measure: visual analogue scale
timeFrame: Screening, day 30, day 60
measure: Changes in serum cortisol levels
timeFrame: Screening, day 15, day 60
measure: Change in serum serotonin levels
timeFrame: Screening, day 30, day 45
measure: Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
timeFrame: After stopping treatment for 1 week (day 68)
measure: Change in mood assessed using the Profile of Mood States (POMS)
timeFrame: Screening, day 15, day 30, 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, baseline, day 15, day 30, day 45, day 60
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Screening, baseline, day 15, day 30, day 45, day 60
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Screening, baseline, day 15, day 30, day 45, 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 difference from reference measurement (mg/dl)
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: