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

NCT06571071 | Not Yet Recruiting DMC

• 2 other identifiers: MHC/CT/24-25/016CTRI/2024/07/071254
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stress; Anxiety

Keywords

stress; Anxiety

Outcome Measures

Primary Outcomes (13)

• 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 1. = Resolved symptom 2. = Ongoing symptoms requiring no medical assistance 3. = 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 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, baseline, day 15, day 30, day 45, day 60

• Diastolic blood pressure difference from reference measurement (mmHg)

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

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

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

Study Arms (3)

De-Stress and Chill Gummies-U001

EXPERIMENTAL

Other: De-Stress and Chill Gummies-U001

De-Stress and Chill Gummies-I001

EXPERIMENTAL

Other: De-Stress and Chill Gummies-I001

Placebo Gummies-001

PLACEBO COMPARATOR

Other: Placebo Gummies-001

Interventions

De-Stress and Chill Gummies-U001 OTHER

Two gummies in sequence daily after meal for 60 days

De-Stress and Chill Gummies-U001

De-Stress and Chill Gummies-I001 OTHER

Two gummies in sequence daily after meal for 60 days

De-Stress and Chill Gummies-I001

Placebo Gummies-001 OTHER

Two gummies in sequence daily after meal for 60 days

Placebo Gummies-001

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
• 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
• 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
• \. Willing to limit caffeine consumption while in the study.

You may not qualify if:

• Inability to perform any of the assessments required for endpoint analysis
• 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)
• Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress management
• Have any other neurodegenerative diseases or seizure disorder
• Known hypersensitivity to investigational products
• Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
• Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
• Sitting or resting systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg at screening
• Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within the last 5 years
• 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.

Sponsors & Collaborators

• Herbolab India Pvt. Ltd.: lead

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

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