NCT06571071

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Herbolab India Pvt. Ltd. · Industry
• Sex: All
• Age: 21 Years – 50 Years
• Healthy volunteers: Accepted

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.

Conditions

• Stress
• Anxiety

Interventions

Type	Name	Description
OTHER	De-Stress and Chill Gummies-U001	Two gummies in sequence daily after meal for 60 days
OTHER	De-Stress and Chill Gummies-I001	Two gummies in sequence daily after meal for 60 days
OTHER	Placebo Gummies-001	Two gummies in sequence daily after meal for 60 days

Timeline

• Start date: 2024-09-05
• Primary completion: 2024-11-25
• Completion: 2024-12-28
• First posted: 2024-08-26
• Last updated: 2024-08-26