An interventional study of De-Stress and Chill Gummies-U001 and De-Stress and Chill Gummies-I001 in Stress and Anxiety, sponsored by Herbolab India Pvt. Ltd.. Not yet recruiting. Open to participants aged 21 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-08-26.
Sponsored by Herbolab India Pvt. Ltd. · Not applicable, Interventional, and Supportive care
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.
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.
7,201 studies on the registry are indexed under Anxiety Disorders; 1,682 are open to participants now.
This study's planned enrollment of 72 is close to the median of 80 across 6,057 interventional studies indexed under Anxiety Disorders.
Browse Anxiety Disorders studies →Herbolab India Pvt. Ltd. is the lead sponsor of 5 studies on the registry; 5 are open to participants now.
Compared within Anxiety Disorders, the registry's first condition term, which may not be this study's main condition. Counted across the registry records on this site, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Other: De-Stress and Chill Gummies-U001
Other: De-Stress and Chill Gummies-I001
Other: Placebo Gummies-001
Two gummies in sequence daily after meal for 60 days
Two gummies in sequence daily after meal for 60 days
Two gummies in sequence daily after meal for 60 days
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.
Time frame: Screening, day 30, day 60
Changes in Creatine kinase
Blood level of Creatine kinase was measured. (U/L)
Time frame: Screening, day 30, day 60
Changes in Lactate dehydrogenase(LDH)
Blood level Lactate dehydrogenase of was measured. (U/L)
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Screening, day 30, day 60
Changes in serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Time frame: Screening, day 15, day 60
Change in serum serotonin levels
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Time frame: 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
Time frame: 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.
Time frame: Screening, day 15, day 30, day 60
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
It is measure in terms of percentage
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Complete blood count
White blood cell and platelet count \[Thousand per microliter (Thousand/uL)\] Red blood cell count \[Millions per microliter (million/uL)\]
Time frame: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Blood level of SGPT was measured. (U/L)
Time frame: Screening and day 60
serum glutamic-oxaloacetic transaminase (SGOT)
Blood level of SGOT was measured. (U/L)
Time frame: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Blood levels of Creatinine was measured. (mg/dl)
Time frame: Screening and day 60
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Herbolab India Pvt. Ltd.