StressNCT06571331
A Clinical Trial of De-Stress & Snooze Gummies in Reducing Stress and Insomnia Disorder
A study testing De-Stress & Snooze Gummies-U001 and De-Stress & Snooze Gummies-I001 in people with Stress and Insomnia, run by Herbolab India Pvt. Ltd..
Trial summary
The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. Read more about this study
- Who is it for?
- Ages 21 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Insomnia, Quality of Life
- What is being tested?
- De-Stress & Snooze Gummies-U001 and De-Stress & Snooze Gummies-I001
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 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
- Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR
- Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate
- Participants with a diagnosis of mild or moderate depression patient's health questionnaire PHQ-9 score of less than or equal to 14
- Participants with a diagnosis of mild or moderate generalized anxiety disorder GAD -7 questionnaire score of less than or equal to 10.
Who cannot join
- Difficulty sleeping due to a medical condition
- History of a neurological disorder
- History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication
- On-going depression and generalized anxiety disorder diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales
- History of substance abuse or dependence
- History or current evidence of a clinically significant cardiovascular disorder at pre-study visit
Show all 14Show fewer
- Taking certain prohibited medications
- Consumption of greater than 10 cigarettes a day
- Participants who consume greater than or equal to 120 mg/day of caffeine and are unwilling to restrict their intake throughout the study
- Current evidence or history of malignancy less than or equal to 5 years prior to signing informed consent
- Participants currently using any nutraceutical, allopathic, or ayurvedic supplement for stress or insomnia management
- Known hypersensitivity to any ingredients of product
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- Other conditions, which in the opinion of the investigators, makes the participant unsuitable for enrolment or could interfere with his her participation in and completion of the protocol.
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 Snooze Gummies in Reducing Stress, Insomnia Disorder, Associated Symptoms and Overall Quality of Life
The current study focuses on clinical validation of efficacy of nutraceutical product in management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a good night's sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind.
Read the detailed description
A randomized, double-blind, placebo-controlled clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms, and overall quality of life.
More than 60 Participants will be randomized to either one of the following groups:
Group A, Group B, and Group C will involve 20 participants each group (1:1:1 ratio) will be advised to take Destress and snooze gummies - U001, Destress and snooze gummies - I001, and Placebo gummies-002, respectively two gummies in sequence daily, 30 minutes before bed, for 60 days. The treatment duration is of 60 days and the study duration is of 68 days. The efficacy of the investigational product will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening.
Assessments of changes in stress through PSS scores, serum serotonin, restorative sleep by RSQ-W score, under eye dark circles based on bespoke scale, and headache by VAS score will be conducted on screening, day 30 and day 60.
Changes in serum cortisol levels will be evaluated at screening, day 15, and day 60. Additionally, participants' sleep diaries will be assessed to determine the changes in total sleep time, sleep latency, number of awakenings, wake time after sleep onset, sleep efficiency (total sleep time/time in bed * 100), and levels of alertness and drowsiness and actigraphy assessment using Fitbit device to evaluate sleep efficiency (deep sleep, light sleep, and REM sleep duration, as well as overall sleep scores) which will be tracked for 10 individuals (3-4 subjects per group) at baseline, day 30, and day 60.
Changes in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) and the abbreviated Profile of Mood States (POMS-A) score to investigate mood changes and safety through complete blood count, liver function test, and kidney function test will be assessed at screening and day 60.
Changes in the modified sleep regularity and medication withdrawal questionnaire (MSRMWQ) score will be assessed after ceasing treatment for one week (day 68), telephonically.
Treatment compliance and tolerability will be assessed at day 30 and day 60, and safety of the investigational treatment in terms of adverse events will be assessed at baseline, day 15, day 45, and day 60. Changes in vital sign parameters will be assessed at screening, baseline, day 15, day 30, day 45 and day 60.
- Conditions
- Stress, Insomnia, Quality of Life
- Being tested
- De-Stress & Snooze Gummies-U001, De-Stress & Snooze Gummies-I001, Placebo Gummies 002
- Keywords
- Stress, Insomnia, Quality of Life
- Medical subject headings
- Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-Stress & Snooze Gummies-U001Other
Two gummies daily in sequence 30-45 minutes before bed for 60 days
De-Stress & Snooze Gummies-I001Other
Two gummies daily in sequence 30-45 minutes before bed for 60 days
Placebo Gummies 002Other
Two gummies daily in sequence 30-45 minutes before bed for 60 days
| Study group | Role | What they receive |
|---|---|---|
| De-Stress & Snooze Gummies-U001 | Experimental | Not described Receives: Other: De-Stress & Snooze Gummies-U001 |
| De-Stress & Snooze Gummies-I001 | Experimental | Not described Receives: Other: De-Stress & Snooze Gummies-I001 |
| Placebo Gummies 002 | Placebo comparator | Not described Receives: Other: Placebo Gummies 002 |
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
Restorative Sleep Questionnaire Weekly Version (RSQ-W)
Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly). It is a 9 item scale questioner. Scoring interpretation: A total score is calculated as the average of the questionnaire items. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep. To convert the average score to a 0-100 scale, the following transformation is used: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1} *25.
Measured: Screening, day 30 and day 60
Number of Participants Who Showed Improvement in Under Eye Dark Circle
The interpretation will be like No Dark Circles (No visible dark circles under the eyes); 1: Minimal Dark Circles (Slight discoloration or shadow, barely noticeable); 2: Mild Dark Circles (Noticeable darkening, but not prominent or severe); 3: Moderate Dark Circles (Prominent dark circles with moderate intensity); 4: Severe Dark Circles (Intense and distinct dark circles, may appear blueish-black); 5: Blueish Black Dark Circles (Extreme and prominent dark circles with a deep blue or black hue).
Measured: Screening, day 30 and 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 and day 60
Change in Sleep Efficiency
Sleep efficiency will be calculated using information by actigraphy from Fitbit device.
Sleep efficiency in terms of - Deep sleep, light sleep, REM sleep duration and overall sleep score by actigraphy (Fitbit device) for 10 subjects (3-4 subjects in each group).
Measured: Baseline, day 30 ad day 60
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
Measured: Score after stopping treatment for 1 week (day 68)
Changes in serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Measured: Screening, day 15 and day 60
Change in serum serotonin levels
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Measured: Screening, day 30 and day 45
Change in FOSQ-10 score Profile of Mood State (POMS) questionnaire
Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 10-40 with higher scores indicating higher functional.
Measured: Screening and day 28
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 28
Changes in outcomes from participant sleep diary
Sleep diary parameters - total sleep time in minutes, sleep latency in minutes, number of awakenings in numbers, wake time after sleep onset in minutes, sleep efficiency in percentage (Total sleep time/ time in bed*100), alertness and drowsiness will be recorded using 5-point scale.
Measured: Baseline, day 30 and day 60
Secondary outcomes (9)
Safety of participant Assessed using adverse events
It is measured 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 and day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Assessed against standard clinical grade instrument: automated oscillometric blood pressure device (mmHg)
Measured: Screening and 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 and 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
Creatinine difference from reference measurement (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
- 60 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
- NCT06571331
- Sponsor's protocol ID
- MHC/CT/24-25/019
- Other IDs
- CTRI/2024/07/071253
- 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 and Snooze Gummies in Reducing Stress, Insomnia Disorder, Associated Symptoms and Overall Quality of Life
- ClinicalTrials.gov ID
- NCT06571331
- Acronym / sponsor ID
- MHC/CT/24-25/019
- Conditions
- Stress, Insomnia, Quality of Life
- Keywords
- Stress, Insomnia, Quality of Life
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 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 management of sleep disorder. Improved sleep quality contributes significantly to cognitive function. With a good night's sleep, individuals often find themselves more alert, focused, and better equipped to handle complex tasks and problem-solving scenarios. This can enhance productivity at work, as well as improve the ability to engage in meaningful conversations and activities. Memory consolidation, which occurs during sleep, is also optimized, leading to better retention of information and a sharper mind.
Detailed description
A randomized, double-blind, placebo-controlled clinical trial of De-Stress and Snooze Gummies in reducing stress, insomnia disorder, associated symptoms, and overall quality of life.
More than 60 Participants will be randomized to either one of the following groups:
Group A, Group B, and Group C will involve 20 participants each group (1:1:1 ratio) will be advised to take Destress and snooze gummies - U001, Destress and snooze gummies - I001, and Placebo gummies-002, respectively two gummies in sequence daily, 30 minutes before bed, for 60 days. The treatment duration is of 60 days and the study duration is of 68 days. The efficacy of the investigational product will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening.
Assessments of changes in stress through PSS scores, serum serotonin, restorative sleep by RSQ-W score, under eye dark circles based on bespoke scale, and headache by VAS score will be conducted on screening, day 30 and day 60.
Changes in serum cortisol levels will be evaluated at screening, day 15, and day 60. Additionally, participants' sleep diaries will be assessed to determine the changes in total sleep time, sleep latency, number of awakenings, wake time after sleep onset, sleep efficiency (total sleep time/time in bed * 100), and levels of alertness and drowsiness and actigraphy assessment using Fitbit device to evaluate sleep efficiency (deep sleep, light sleep, and REM sleep duration, as well as overall sleep scores) which will be tracked for 10 individuals (3-4 subjects per group) at baseline, day 30, and day 60.
Changes in the Functional Outcomes of Sleep Questionnaire (FOSQ-10) and the abbreviated Profile of Mood States (POMS-A) score to investigate mood changes and safety through complete blood count, liver function test, and kidney function test will be assessed at screening and day 60.
Changes in the modified sleep regularity and medication withdrawal questionnaire (MSRMWQ) score will be assessed after ceasing treatment for one week (day 68), telephonically.
Treatment compliance and tolerability will be assessed at day 30 and day 60, and safety of the investigational treatment in terms of adverse events will be assessed at baseline, day 15, day 45, and day 60. Changes in vital sign parameters will be assessed at screening, baseline, day 15, day 30, day 45 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 & Snooze Gummies-U001 | Experimental | Other: De-Stress & Snooze Gummies-U001 |
| De-Stress & Snooze Gummies-I001 | Experimental | Other: De-Stress & Snooze Gummies-I001 |
| Placebo Gummies 002 | Placebo comparator | Other: Placebo Gummies 002 |
Who may qualify
- Ages
- 21 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 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
- Participants diagnosed with insomnia disorder based on the Diagnostic and Statistical Manual of Mental Disorders text revision DSM-V-TR
- Insomnia Severity Index more than 7 and less than 21 i.e. mild to moderate
Key exclusion criteria (14 listed)
- Difficulty sleeping due to a medical condition
- History of a neurological disorder
- History of bipolar disorder psychotic disorder or posttraumatic stress disorder or current psychiatric disorder that requires medication
- On-going depression and generalized anxiety disorder diagnosis on PHQ 9 score greater than or equal to 15 and GAD-7 score greater than or equal to 11 scales
- History of substance abuse or dependence
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 & Snooze Gummies-U001Two gummies daily in sequence 30-45 minutes before bed for 60 days | Other | De-Stress & Snooze Gummies-U001 |
| De-Stress & Snooze Gummies-I001Two gummies daily in sequence 30-45 minutes before bed for 60 days | Other | De-Stress & Snooze Gummies-I001 |
| Placebo Gummies 002Two gummies daily in sequence 30-45 minutes before bed for 60 days | Other | Placebo Gummies 002 |
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.
Restorative Sleep Questionnaire Weekly Version (RSQ-W)
Time frame: Screening, day 30 and day 60
Total score of how an individual rates the restorative value of his/her sleep in the morning using the weekly version of the Restorative Sleep Questionnaire (RSQ-Weekly). It is a 9 item scale questioner. Scoring interpretation: A total score is calculated as the average of the questionnaire items. The total score ranges from 0 to 100, with higher scores indicating better restorative sleep. To convert the average score to a 0-100 scale, the following transformation is used: RSQ-W Total Score = {RSQ-W Average Score Across Completed Items - 1} *25.
Number of Participants Who Showed Improvement in Under Eye Dark Circle
Time frame: Screening, day 30 and day 60
The interpretation will be like No Dark Circles (No visible dark circles under the eyes); 1: Minimal Dark Circles (Slight discoloration or shadow, barely noticeable); 2: Mild Dark Circles (Noticeable darkening, but not prominent or severe); 3: Moderate Dark Circles (Prominent dark circles with moderate intensity); 4: Severe Dark Circles (Intense and distinct dark circles, may appear blueish-black); 5: Blueish Black Dark Circles (Extreme and prominent dark circles with a deep blue or black hue).
visual analogue scale
Time frame: Screening, day 30 and 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.
Change in Sleep Efficiency
Time frame: Baseline, day 30 ad day 60
Sleep efficiency will be calculated using information by actigraphy from Fitbit device. Sleep efficiency in terms of - Deep sleep, light sleep, REM sleep duration and overall sleep score by actigraphy (Fitbit device) for 10 subjects (3-4 subjects in each group).
Changes in Modified sleep regularity and medication withdrawal questionnaire (MSRMWQ)
Time frame: Score 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
Changes in serum cortisol levels
Time frame: Screening, day 15 and day 60
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Change in serum serotonin levels
Time frame: Screening, day 30 and day 45
The serotonin secretion will be evaluated by measuring morning serum serotonin levels.
Change in FOSQ-10 score Profile of Mood State (POMS) questionnaire
Time frame: Screening and day 28
Functional Outcomes of Sleep Questionnaire (FOSQ-10): Subscale scores range from 1-4 (1= extreme difficulty, 2= moderate difficulty, 3= a little difficulty, 4= no difficulty) with total scores ranging from 10-40 with higher scores indicating higher functional.
Profile of Mood State (POMS) questionnaire
Time frame: Screening and day 28
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.
Changes in outcomes from participant sleep diary
Time frame: Baseline, day 30 and day 60
Sleep diary parameters - total sleep time in minutes, sleep latency in minutes, number of awakenings in numbers, wake time after sleep onset in minutes, sleep efficiency in percentage (Total sleep time/ time in bed*100), alertness and drowsiness will be recorded using 5-point scale.
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 and day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Screening and day 60
Pulse rate difference from reference measurement (beats per minute)
Time frame: Screening and 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
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 & Snooze Gummies-U001 and De-Stress & Snooze Gummies-I001 in people with Stress and Insomnia, 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 7 inclusion and 14 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 and day 60). The study lists 11 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.