StressNCT06571071
A Clinical Study of De-Stress & Chill Gummies in Reducing Stress
A study testing De-Stress and Chill Gummies-U001 and De-Stress and Chill Gummies-I001 in people with Stress and Anxiety, run by Herbolab India Pvt. Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- What is being tested?
- De-Stress and Chill Gummies-U001 and De-Stress and Chill Gummies-I001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 5 Sep 2024to 28 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
- 7. Willing to limit caffeine consumption while in the study.
Who cannot join
- 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
Show all 10Show fewer
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
Read the 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.
- Being tested
- De-Stress and Chill Gummies-U001, De-Stress and Chill Gummies-I001, Placebo Gummies-001
- Keywords
- stress, Anxiety
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-Stress and Chill Gummies-U001Other
Two gummies in sequence daily after meal for 60 days
De-Stress and Chill Gummies-I001Other
Two gummies in sequence daily after meal for 60 days
Placebo Gummies-001Other
Two gummies in sequence daily after meal for 60 days
| Study group | Role | What they receive |
|---|---|---|
| De-Stress and Chill Gummies-U001 | Experimental | Not described Receives: Other: De-Stress and Chill Gummies-U001 |
| De-Stress and Chill Gummies-I001 | Experimental | Not described Receives: Other: De-Stress and Chill Gummies-I001 |
| Placebo Gummies-001 | Placebo comparator | Not described Receives: Other: Placebo Gummies-001 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Screening, day 30, day 60
Changes in Creatine kinase
Blood level of Creatine kinase was measured. (U/L)
Measured: Screening, day 30, day 60
Changes in Lactate dehydrogenase(LDH)
Blood level Lactate dehydrogenase of was measured. (U/L)
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Screening, day 30, day 60
Changes in serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Measured: Screening, day 15, day 60
Change in serum serotonin levels
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Measured: 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
Measured: 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.
Measured: Screening, day 15, day 30, day 60
Secondary outcomes (9)
Safety of participant Assessed using adverse events
It is measure in terms of No. of events
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)]
Measured: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Blood level of SGPT was measured. (U/L)
Measured: Screening and day 60
serum glutamic-oxaloacetic transaminase (SGOT)
Blood level of SGOT was measured. (U/L)
Measured: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Blood levels of Creatinine was measured. (mg/dl)
Measured: Screening and day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start5 Sep 2024 (estimated)
- Primary completion25 Nov 2024 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for StressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, Double blind, Parallel Group, Placebo Controlled Trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herbolab India Pvt. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Ramshyam Agarwal, MBBS, DNB, Principal investigator, Lokmanya Medical Research Centre and Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06571071
- Sponsor's protocol ID
- MHC/CT/24-25/016
- Other IDs
- CTRI/2024/07/071254
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 26 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06571071
- Acronym / sponsor ID
- MHC/CT/24-25/016
- Keywords
- stress, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Herbolab India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 25 Nov 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 26 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
- Model description
- Randomized, Double blind, Parallel Group, Placebo Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| De-Stress and Chill Gummies-U001Two gummies in sequence daily after meal for 60 days | Other | De-Stress and Chill Gummies-U001 |
| De-Stress and Chill Gummies-I001Two gummies in sequence daily after meal for 60 days | Other | De-Stress and Chill Gummies-I001 |
| Placebo Gummies-001Two gummies in sequence daily after meal for 60 days | Other | Placebo Gummies-001 |
Primary outcome
Perceived Stress Scale
Time frame: Screening, day 30, day 60
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.
Changes in Creatine kinase
Time frame: Screening, day 30, day 60
Blood level of Creatine kinase was measured. (U/L)
Changes in Lactate dehydrogenase(LDH)
Time frame: Screening, day 30, day 60
Blood level Lactate dehydrogenase of was measured. (U/L)
Body Mass Index (BMI)
Time frame: Screening, day 30, day 60
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
Mental chatter 5-point scale
Time frame: Screening, day 30, day 60
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
Assessment of anxiety using Hamilton Anxiety Rating Scale (HAM-A)
Time frame: Screening, day 30, day 60
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.
COPE Questionnaire
Time frame: Screening, day 30, day 60
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.
STAI (State-Trait Anxiety Inventory)
Time frame: Screening, day 30, day 60
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).
visual analogue scale
Time frame: Screening, day 30, day 60
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.
Changes in serum cortisol levels
Time frame: Screening, day 15, day 60
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Change in serum serotonin levels
Time frame: Screening, day 30, day 45
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
Time frame: After stopping treatment for 1 week (day 68)
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
Change in mood assessed using the Profile of Mood States (POMS)
Time frame: Screening, day 15, day 30, day 60
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.
9 secondary outcomes
Safety of participant Assessed using adverse 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
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Pulse rate difference from reference measurement (beats per minute)
Time frame: Screening, baseline, day 15, day 30, day 45, day 60
Complete blood count
Time frame: Screening and day 60
Serum Glutamic Pyruvic Transaminase (SGPT)
Time frame: Screening and day 60
serum glutamic-oxaloacetic transaminase (SGOT)
Time frame: Screening and day 60
Creatinine difference from reference measurement (mg/dl)
Time frame: Screening and day 60
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr. Ramshyam Agarwal, MBBS, DNB principal investigator
Lokmanya Medical Research Centre and Hospital
Questions about this trial
What is this clinical trial studying?
A study testing De-Stress and Chill Gummies-U001 and De-Stress and Chill Gummies-I001 in people with Stress and Anxiety, run by Herbolab India Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Kriti Soni, PhD (+91 9871018383, kriti.soni@rpsg.in), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perceived Stress Scale (time frame: Screening, day 30, day 60). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2024.