StressNCT06568965
Clinical Study of De-Stress & Happy Gut Powder for Stress and Indigestion in Adults.
A study testing De-stress & happy gut powder-U001 and De-Stress & Happy Gut powder-I001 in people with Stress and Dyspepsia, run by Herbolab India Pvt. Ltd..
Trial summary
The current study focuses on clinical validation of efficacy of nutraceutical product in relieving stress and functional dyspepsia symptoms in adults for gut health. The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Dyspepsia, Indigestion
- What is being tested?
- De-stress & happy gut powder-U001 and De-Stress & Happy Gut powder-I001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 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
- Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria
- Participant should be suffering with at least 4 or more symptoms mentioned below and with a total symptom score of 20 or more based on a 7-point Likert scale (a) Upper abdominal fullness (b) Upper abdominal pain (c) Belching (d) Bloating (e) Early satiety (f) Nausea (g) Vomiting (h) Regurgitation (i) Heartburn (j) Loss of appetite
Who cannot join
- Inability to perform any of the assessments required for endpoint analysis
- Known hypersensitivity to investigational products
- Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
- Advanced chronic illness that would impair follow-up or monitoring
- Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment. Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management;
- Participants suffering from abdominal obesity that is waist circumference of more than 80 cm in females and of more than 90 cm in male;
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
- Participants with current or past diagnoses of peptic ulcer disease, gastroesophageal reflux disorder (GERD), or irritable bowel syndrome (IBS), as well as those who have undergone surgery related to these conditions
- Have any other neurodegenerative diseases, mental illness or dementia
- Any other clinical condition in the judgment of investigator finds the study participation unsuitable for the participant.
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 and Happy Gut Powder in Relieving Stress and Functional Dyspepsia Symptoms in Adults.
The current study focuses on clinical validation of efficacy of nutraceutical product in relieving stress and functional dyspepsia symptoms in adults for gut health. The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being. Improved digestive health leads to better nutrient absorption, which is essential for energy levels and immune function. Reduced stress levels contribute to better sleep quality, cognitive function, and emotional stability.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-arm, clinical trial of De-Stress \& Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults.
In this study, more than 81 participants will be enrolled in a 1:1:1 ratio into three groups: Group A (De-stress \& Happy Gut Powder-U001), Group B (De-stress \& Happy Gut Powder-I001), and Group C (Placebo Powder 001). Each participant will take one sachet daily, 30 minutes before breakfast, for 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening. The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale (PSS) score, Nepean Dyspepsia Index (NDI), changes in serum cortisol levels, changes in the COPE Questionnaire (a. Positive Subscale, b. Denial Subscale) score, assessing gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score will be assessed at screening, day 30, and day 60.
Changes in the State-Trait Anxiety Inventory (STAI) score, changes in the Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance, b. Depression) will be assessed at screening and day 60.
Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia (Upper abdominal fullness, Pain, Belching, Bloating, Early satiety, Nausea, Vomiting, Regurgitation, Heartburn, Loss of appetite, cravings for junk food) will be assessed at screening, day 15, 30, and day 60.
Changes in gut microbiota at screening and day 60; and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn will be assessed at baseline, day 15, 30, and day 60.
Treatment compliance, tolerability of investigational products will be assessed at day 30 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, and day 60.
Assessment of changes in vital sign parameters will be done from screening to end of the study (Day 60).
- Conditions
- Stress, Dyspepsia, Indigestion
- Being tested
- De-stress & happy gut powder-U001, De-Stress & Happy Gut powder-I001, Placebo Powder 001
- Keywords
- stress, Dyspepsia, Indigestion
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-stress & happy gut powder-U001Other
Take one sachet daily, 30 minutes before breakfast, for 60 days
De-Stress & Happy Gut powder-I001Other
Take one sachet daily, 30 minutes before breakfast, for 60 days
Placebo Powder 001Other
Take one sachet daily, 30 minutes before breakfast, for 60 days
| Study group | Role | What they receive |
|---|---|---|
| De-stress & happy gut powder-U001 | Experimental | Not described Receives: Other: De-stress & happy gut powder-U001 |
| De-Stress & Happy Gut powder-I001 | Experimental | Not described Receives: Other: De-Stress & Happy Gut powder-I001 |
| Placebo Powder 001 | Other | Not described Receives: Other: Placebo Powder 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 and day 60
Short Form of Nepean Dyspepsia Index (SF-NDI)
The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.
The total score gives an overall measure of the impact of dyspepsia on the individual, with higher scores indicating more severe symptoms or greater impairment in quality of life due to dyspepsia.
Measured: Screening, day 30 and 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 and day 60
Gastrointestinal Symptom Rating Scale (GSRS)
The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms.
Measured: Screening, day 30 and day 60
Time required to relief pain for acid reflux flare/heartburn symptoms
Participants should consume the investigational product during an acid reflux flare-up or heartburn and record the time taken to achieve relief.
The time will be recorded.
Measured: Screening, day 30 and 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 and day 60
Profile of Mood State (POMS) questionnaire
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 and day 60
Change in serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels
Measured: Screening, day 15 and day 60
Changes in 7 point Likert scale scores
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) 1 - No discomfort at all, 2- Minor discomfort, 3- Mild discomfort, 4- Moderate discomfort, 5- Moderately severe discomfort, 6- Severe discomfort, 7- Very severe discomfort
Measured: Screening, day 15, 30 and day 60
Secondary outcomes (9)
Safety of participant Assessed using adverse events
It is measure in terms of No. of events parameters.
Measured: Screening, baseline, day 15, day 30, 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 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 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 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 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 posted23 Aug 2024
- Study start5 Sep 2024 (estimated)
- Primary completion20 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
- 81 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
- NCT06568965
- Sponsor's protocol ID
- MHC/CT/24-25/015
- Other IDs
- CTRI/2024/07/071248
- Status last verified
- Aug 2024
- First submitted
- 10 Aug 2024
- Last updated
- 23 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 23 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 and Happy Gut Powder in Relieving Stress and Functional Dyspepsia Symptoms in Adults.
- ClinicalTrials.gov ID
- NCT06568965
- Acronym / sponsor ID
- MHC/CT/24-25/015
- Conditions
- Stress, Dyspepsia, Indigestion
- Keywords
- stress, Dyspepsia, Indigestion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- Herbolab India Pvt. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Sep 2024 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 23 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 relieving stress and functional dyspepsia symptoms in adults for gut health. The effect of these nutraceuticals not only targets the physical symptoms but also enhances overall well-being. Improved digestive health leads to better nutrient absorption, which is essential for energy levels and immune function. Reduced stress levels contribute to better sleep quality, cognitive function, and emotional stability.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-arm, clinical trial of De-Stress \& Happy Gut powder in relieving stress and functional dyspepsia symptoms in adults.
In this study, more than 81 participants will be enrolled in a 1:1:1 ratio into three groups: Group A (De-stress \& Happy Gut Powder-U001), Group B (De-stress \& Happy Gut Powder-I001), and Group C (Placebo Powder 001). Each participant will take one sachet daily, 30 minutes before breakfast, for 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening. The efficacy of the intervention will be assessed by evaluating changes in the Perceived Stress Scale (PSS) score, Nepean Dyspepsia Index (NDI), changes in serum cortisol levels, changes in the COPE Questionnaire (a. Positive Subscale, b. Denial Subscale) score, assessing gut health using a Gastrointestinal Symptom Rating Scale (GSRS) score will be assessed at screening, day 30, and day 60.
Changes in the State-Trait Anxiety Inventory (STAI) score, changes in the Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance, b. Depression) will be assessed at screening and day 60.
Changes in symptom score on a 7-point Likert scale to grade overall symptoms of dyspepsia (Upper abdominal fullness, Pain, Belching, Bloating, Early satiety, Nausea, Vomiting, Regurgitation, Heartburn, Loss of appetite, cravings for junk food) will be assessed at screening, day 15, 30, and day 60.
Changes in gut microbiota at screening and day 60; and time in seconds for relief from pain and heartburn in 5-10 subjects recommended to be used on a need basis in case of acid reflux flare/heartburn will be assessed at baseline, day 15, 30, and day 60.
Treatment compliance, tolerability of investigational products will be assessed at day 30 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, and day 60.
Assessment of changes in vital sign parameters will be done from screening to end of the study (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 & happy gut powder-U001 | Experimental | Other: De-stress & happy gut powder-U001 |
| De-Stress & Happy Gut powder-I001 | Experimental | Other: De-Stress & Happy Gut powder-I001 |
| Placebo Powder 001 | Other | Other: Placebo Powder 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
- Diagnosis of functional dyspepsia/non-ulcer dyspepsia by fulfilling Rome-III criteria
Key exclusion criteria (10 listed)
- Inability to perform any of the assessments required for endpoint analysis
- Known hypersensitivity to investigational products
- Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within last 5 years
- Advanced chronic illness that would impair follow-up or monitoring
- Participants who have used dietary supplements, medications, such as oral/IV antibiotics or probiotics, or supplements known to affect hunger, satiety, appetite, or gut microbiome within three months prior to recruitment. Additionally, individuals currently using nutraceuticals, allopathic, or ayurvedic supplements for stress and or gastrointestinal health management;
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 & happy gut powder-U001Take one sachet daily, 30 minutes before breakfast, for 60 days | Other | De-stress & happy gut powder-U001 |
| De-Stress & Happy Gut powder-I001Take one sachet daily, 30 minutes before breakfast, for 60 days | Other | De-Stress & Happy Gut powder-I001 |
| Placebo Powder 001Take one sachet daily, 30 minutes before breakfast, for 60 days | Other | Placebo Powder 001 |
Primary outcome
Perceived Stress Scale
Time frame: Screening, day 30 and 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.
Short Form of Nepean Dyspepsia Index (SF-NDI)
Time frame: Screening, day 30 and day 60
The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50. The total score gives an overall measure of the impact of dyspepsia on the individual, with higher scores indicating more severe symptoms or greater impairment in quality of life due to dyspepsia.
COPE Questionnaire
Time frame: Screening, day 30 and 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.
Gastrointestinal Symptom Rating Scale (GSRS)
Time frame: Screening, day 30 and day 60
The GSRS contains 15 items. All individual items are scored on a 7-point Likert scale (1 = not at all to 7 = extremely) and are subsequently clustered into five domains (abdominal pain, reflux, indigestion, diarrhea, and constipation); higher scores indicate more severe symptoms.
Time required to relief pain for acid reflux flare/heartburn symptoms
Time frame: Screening, day 30 and day 60
Participants should consume the investigational product during an acid reflux flare-up or heartburn and record the time taken to achieve relief. The time will be recorded.
STAI (State-Trait Anxiety Inventory)
Time frame: Screening and 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).
Profile of Mood State (POMS) questionnaire
Time frame: Screening and 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.
Change in serum cortisol levels
Time frame: Screening, day 15 and day 60
The cortisol secretion will be evaluated by measuring morning serum cortisol levels
Changes in 7 point Likert scale scores
Time frame: Screening, day 15, 30 and day 60
The score of patients on the degree of remission of gastroesophageal reflux disease symptoms (acid reflux and heartburn) 1 - No discomfort at all, 2- Minor discomfort, 3- Mild discomfort, 4- Moderate discomfort, 5- Moderately severe discomfort, 6- Severe discomfort, 7- Very severe discomfort
9 secondary outcomes
Safety of participant Assessed using adverse events
Time frame: Screening, baseline, day 15, day 30, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
Time frame: Screening, baseline, day 15, day 30, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 15, day 30, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening, baseline, day 15, day 30, day 60
Pulse rate difference from reference measurement (beats per minute)
Time frame: Screening, baseline, day 15, day 30, 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 23 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Stress
Not yet recruiting
Effect of Stress Ball Use During Femoral Arterial Sheath Removal After Coronary Angiography
Femoral Arterial Sheath Removal, Stress Ball
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
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 & happy gut powder-U001 and De-Stress & Happy Gut powder-I001 in people with Stress and Dyspepsia, 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 23 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. 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 and day 60). The study lists 9 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 23 Aug 2024.