AnxietyNCT06569849
A Clinical Trial of De-stress and Focus Capsule in the Management of Stress.
A study testing De-Stress and Focus capsule- U001 and De-Stress and Focus capsule - I001 in people with Anxiety and Stress, run by Herbolab India Pvt. Ltd..
Trial summary
The current study focuses in clinical validation of the efficacy of nutraceutical product in the management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- De-Stress and Focus capsule- U001 and De-Stress and Focus capsule - I001
- Type of treatment
- Pill or oral medicine
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male and female participants aged 18-50 years both inclusive
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Scoring 18-26 on the Montreal Cognitive Assessment MoCA
- No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ
- Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
- No severe anxiety and depression on GAD and PHQ-9 scales
- Able to complete the cognitive assessment tests
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, Lewy Bodies dementia LBD, Cerebrovascular dementia CVD, Progressive Supranuclear Palsy PSP, multiple cerebral infarctions, or normal pressure hydrocephalus NPH, cardiac disease or endocrine disease
- Have any other neurodegenerative diseases
- History of a 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 11Show fewer
- 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
- Participants currently using medications and or supplements that could have cognitive or mood effects including but not limited to nutraceutical, allopathic, ayurvedic herbal extract or supplement
- Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
- Serious illness or any other condition that, in the opinion of the investigator may compromise the safety or compliance of the patient 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 and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety
The current study focuses in clinical validation of the efficacy of nutraceutical product in the management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement. Improved mental focus can lead to increased productivity and efficiency in both personal and professional settings. Individuals who struggle with attention deficits or cognitive fog may find that these supplements help them maintain a sharper and more consistent level of mental clarity. This can translate to better performance at work, as well as improved ability to manage daily tasks and responsibilities.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-arm clinical trial of De-Stress and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety
In this study, more than 60 participants will be enrolled and randomized to either one of the following groups: Group A: De-Stress and Focus Capsules-U001, Group B: De-Stress and Focus Capsules-I001, Group C: Placebo Capsules 001 in 1:1:1 ratio (20 patients in each group). The study duration is 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening.
Assessment of perceived stress scale (PSS) score, Montreal Cognitive Assessment (MoCA) scale score, Rey Complex Figure Test (RCFT), Trail Making Test (TMT) score, digit span memory test - forward and backward for attention and working memory assessment (most extended sequence), fatigue severity scale (FSS) score, mental chatter 5-point scale, Epworth Sleepiness Scale for daytime sleepiness, energy levels by using energy audit diary and adult ADHD Self-Report Scale (ASRS) score will be done at screening, day 30 and day 60.
Assessment of serum cortisol levels will be done at screening, day 15 and day 60.
Assessment of COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, and Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression) will be done at screening and day 60.
Assessment of alertness, orientation, executive control functioning, and executive/arousal vigilance will be assessed using ANTI-Vea-UGR computerized test will be done at 0 hr, 1hr, 4 hr, and 8 hr after dosing on day 1, and day 60 (5 participants from each group i.e, total 15 participants).
Changes in vital sign parameters will be assessed from screening to the end of the study (Day 60). Assessment of changes in complete blood count, liver function test, and kidney function test will be done at screening and end of the study (Day 60). Safety of the investigational treatment in terms of adverse events (AEs), and serious adverse events (SAEs) from screening to end of the study ( Day 60). Treatment compliance and tolerability will be assessed from baseline to the end of the study (Day 60).
- Being tested
- De-Stress and Focus capsule- U001, De-Stress and Focus capsule - I001, Placebo capsules 001
- Keywords
- stress, Mental alertness, Fatigue, Anxiety
- Medical subject headings
- Anxiety Disorders, Stupor, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
De-Stress and Focus capsule- U001Other
Two capsules in sequence daily after meal for 60 days.
De-Stress and Focus capsule - I001Other
Two capsules in sequence daily after meal for 60 days.
Placebo capsules 001Other
Two capsules in sequence daily after meal for 60 days.
| Study group | Role | What they receive |
|---|---|---|
| De-Stress and Focus capsule- U001 | Experimental | Not described Receives: Other: De-Stress and Focus capsule- U001 |
| De-Stress and Focus capsule - I001 | Experimental | Not described Receives: Other: De-Stress and Focus capsule - I001 |
| Placebo capsules 001 | Placebo comparator | Not described Receives: Other: Placebo capsules 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 Baseline day 15 day 30 day 60
Montreal Cognitive Assessment (MoCA)
Montreal Cognitive Assessment (MoCA) MoCA was a questionnaire performed preoperative then post-operative. The MoCA used in this study was developed by Professor Nasreddine in 2004 and is used for the rapid screening assessment of mild cognitive impairment. The cognitive areas assessed by MoCA included attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation. The scale had a total score of 30 points. ≥26 points were considered as having no cognitive impairment .
Measured: Screening, baseline, day 15, day 30, day 60
Rey Complex Figure Test (RCFT)
The RCFT 'copy' is a validated, instrument assessing visuo-constructive abilities. The RCFT 'copy' requires the subject to observe and replicate an image. The score is scored as 0, 0.5, 1 or 2 for each of the 18 factors. Point 2 is when the shape and position of the element is accurately drawn, point 1 is when one of the shape or position is correct. Point 0.5 is when both the shape and position are incorrect, but the examinee can determine what the subject was trying to draw, and point 0 is the case when the shape and position difference are both inadequate, and when the element is not drawn. The total score is the sum of the scores scored for each of the 18 elements; It is possible scores range from 0 to 36(Higher numbers indicate better).
Measured: Screening, baseline, day 15, day 30, day 60
Change in Trail Making Test (TMT) Between Baseline and End of Treatment
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Measured: Screening, baseline, day 15, day 30, day 60
Memory performance assessed using digit span memory test
Digit Span Forward requires the Participant to repeat numbers in the same order as read aloud by the examiner, and Digit Span Backward requires the child to repeat the numbers in the reverse order of that presented by the examiner.
Measured: Screening, baseline, day 15, day 30, day 60
fatigue severity scale (FSS)
The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fatigue and sleep disorders. The FSS items are rated on a 5-point Likert scale, with responses ranging from "not at all" to "extremely." The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.
Measured: Screening, baseline, day 15, 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, baseline, day 15, day 30, day 60
Epworth Sleepiness Scale
How likely is the participant to doze off or fall asleep in the following situations? You should rate their chances of dozing off, not just feeling tired. Even if the participant has not done some of these things recently try to determine how it would have affected them. For each situation, decide whether or not the participant would have: · No chance of dozing =0 · Slight chance of dozing =1 · Moderate chance of dozing =2 · High chance of dozing =3 Write down the number corresponding to the choice in the right hand column.
Interpretation: 0-7: It is unlikely that the participant is abnormally sleepy; 8-9: The participant has an average amount of daytime sleepiness; 10-15: The participant may be excessively sleepy depending on the situation. The participant may want to consider seeking medical attention; 16-24: The participant is excessively sleepy and should consider seeking medical attention.
Measured: Screening, baseline, day 15, day 30, day 60
ADHD Self-Report Scale (ASRS)
The ASRS is an 18-item self-report screening scale used to assess adult ADHD. Each ASRS item contains a five-point scale where participants indicate how frequently they conduct themselves in the described manner; item responses can range from 'Never' to 'Very Often', where responses of 'Often' or 'Very Often' are consistent with ADHD typical dysfunction. When participant responses meet the criterion for ADHD typical dysfunction on at least 4 out of 6 screener items (denoted as 'Part A'), said participant will meet inclusion for the study. The remaining 12 ASRS items ('Part B') will be administered for use in the event that the screener criteria are met, and thus a need for further psychometric gradation arises.
Measured: Screening, baseline, day 15, 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 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 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, day 60
Serum cortisol levels
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
Measured: Screening, day 15 and day 60
ANTI-Vea-UGR computerized test
The Attentional Networks Test for Interactions and Vigilance-executive and arousal components (ANTI-Vea) is a computerized task. The task simultaneously assesses the main effects and interactions of the three attentional networks (i.e., phasic alertness, orienting, and executive control) and two dissociated components of vigilance with reasonable reliability (executive and arousal vigilance).
Measured: 0 hours, 1 hours, 4 hours and 8 hours after dosing at day 1 and day 60
Secondary outcomes (8)
Safety of participant assessed using adverse events.
It is measure in terms of No. of events.
Measured: 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: 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: 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: 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: 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
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 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 AnxietyStudies 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
- NCT06569849
- Sponsor's protocol ID
- MHC/CT/24-25/017
- Other IDs
- CTRI/2024/07/071243
- 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 Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety
- ClinicalTrials.gov ID
- NCT06569849
- Acronym / sponsor ID
- MHC/CT/24-25/017
- Keywords
- stress, Mental alertness, Fatigue, Anxiety
- 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
- 20 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 in clinical validation of the efficacy of nutraceutical product in the management of mental focus and cognition. The benefits of these nutraceuticals extend beyond mere cognitive enhancement. Improved mental focus can lead to increased productivity and efficiency in both personal and professional settings. Individuals who struggle with attention deficits or cognitive fog may find that these supplements help them maintain a sharper and more consistent level of mental clarity. This can translate to better performance at work, as well as improved ability to manage daily tasks and responsibilities.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-arm clinical trial of De-Stress and Focus Capsule in the Management of Stress, Mental Alertness, Fatigue, and Anxiety
In this study, more than 60 participants will be enrolled and randomized to either one of the following groups: Group A: De-Stress and Focus Capsules-U001, Group B: De-Stress and Focus Capsules-I001, Group C: Placebo Capsules 001 in 1:1:1 ratio (20 patients in each group). The study duration is 60 days. The efficacy of the investigational products will be compared between the groups.
Concomitant diseases/medication assessment will be performed on screening.
Assessment of perceived stress scale (PSS) score, Montreal Cognitive Assessment (MoCA) scale score, Rey Complex Figure Test (RCFT), Trail Making Test (TMT) score, digit span memory test - forward and backward for attention and working memory assessment (most extended sequence), fatigue severity scale (FSS) score, mental chatter 5-point scale, Epworth Sleepiness Scale for daytime sleepiness, energy levels by using energy audit diary and adult ADHD Self-Report Scale (ASRS) score will be done at screening, day 30 and day 60.
Assessment of serum cortisol levels will be done at screening, day 15 and day 60.
Assessment of COPE Questionnaire (a. Positive Subscale b. Denial Subscale) score, STAI (State-Trait Anxiety Inventory) score, and Profile of Mood State (POMS) questionnaire score (a. Total Mood Disturbance b. Depression) will be done at screening and day 60.
Assessment of alertness, orientation, executive control functioning, and executive/arousal vigilance will be assessed using ANTI-Vea-UGR computerized test will be done at 0 hr, 1hr, 4 hr, and 8 hr after dosing on day 1, and day 60 (5 participants from each group i.e, total 15 participants).
Changes in vital sign parameters will be assessed from screening to the end of the study (Day 60). Assessment of changes in complete blood count, liver function test, and kidney function test will be done at screening and end of the study (Day 60). Safety of the investigational treatment in terms of adverse events (AEs), and serious adverse events (SAEs) from screening to end of the study ( Day 60). Treatment compliance and tolerability will be assessed from baseline to the 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 and Focus capsule- U001 | Experimental | Other: De-Stress and Focus capsule- U001 |
| De-Stress and Focus capsule - I001 | Experimental | Other: De-Stress and Focus capsule - I001 |
| Placebo capsules 001 | Placebo comparator | Other: Placebo capsules 001 |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Male and female participants aged 18-50 years both inclusive
- Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
- Scoring 18-26 on the Montreal Cognitive Assessment MoCA
- No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ
- Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
Key exclusion criteria (11 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, Lewy Bodies dementia LBD, Cerebrovascular dementia CVD, Progressive Supranuclear Palsy PSP, multiple cerebral infarctions, or normal pressure hydrocephalus NPH, cardiac disease or endocrine disease
- Have any other neurodegenerative diseases
- History of a 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 Focus capsule- U001Two capsules in sequence daily after meal for 60 days. | Other | De-Stress and Focus capsule- U001 |
| De-Stress and Focus capsule - I001Two capsules in sequence daily after meal for 60 days. | Other | De-Stress and Focus capsule - I001 |
| Placebo capsules 001Two capsules in sequence daily after meal for 60 days. | Other | Placebo capsules 001 |
Primary outcome
Perceived Stress Scale
Time frame: Screening Baseline day 15 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.
Montreal Cognitive Assessment (MoCA)
Time frame: Screening, baseline, day 15, day 30, day 60
Montreal Cognitive Assessment (MoCA) MoCA was a questionnaire performed preoperative then post-operative. The MoCA used in this study was developed by Professor Nasreddine in 2004 and is used for the rapid screening assessment of mild cognitive impairment. The cognitive areas assessed by MoCA included attention and concentration, executive function, memory, language, visual structure skills, abstract thinking, calculation and orientation. The scale had a total score of 30 points. ≥26 points were considered as having no cognitive impairment .
Rey Complex Figure Test (RCFT)
Time frame: Screening, baseline, day 15, day 30, day 60
The RCFT 'copy' is a validated, instrument assessing visuo-constructive abilities. The RCFT 'copy' requires the subject to observe and replicate an image. The score is scored as 0, 0.5, 1 or 2 for each of the 18 factors. Point 2 is when the shape and position of the element is accurately drawn, point 1 is when one of the shape or position is correct. Point 0.5 is when both the shape and position are incorrect, but the examinee can determine what the subject was trying to draw, and point 0 is the case when the shape and position difference are both inadequate, and when the element is not drawn. The total score is the sum of the scores scored for each of the 18 elements; It is possible scores range from 0 to 36(Higher numbers indicate better).
Change in Trail Making Test (TMT) Between Baseline and End of Treatment
Time frame: Screening, baseline, day 15, day 30, day 60
Results for both TMT A and B are reported as the number of seconds required to complete the task; therefore, higher scores reveal greater impairment. The reduction in the number of seconds the patients take to make the test after the study treatment means an improvement in cognitive functions.
Memory performance assessed using digit span memory test
Time frame: Screening, baseline, day 15, day 30, day 60
Digit Span Forward requires the Participant to repeat numbers in the same order as read aloud by the examiner, and Digit Span Backward requires the child to repeat the numbers in the reverse order of that presented by the examiner.
fatigue severity scale (FSS)
Time frame: Screening, baseline, day 15, day 30, day 60
The Fatigue Severity Scale (FSS) is a self-reported measure of fatigue and sleep disturbance in patients with fibromyalgia. It is a 9-item scale that assesses the severity of fatigue, the impact of fatigue on daily activities, and the degree of sleep disturbance. The FSS is a widely used instrument in research and clinical practice, and has been found to be a valid and reliable measure of fatigue and sleep disturbance in patients with fatigue and sleep disorders. The FSS items are rated on a 5-point Likert scale, with responses ranging from "not at all" to "extremely." The total score ranges from 0 to 36, with higher scores indicating greater levels of fatigue and sleep disturbance.
mental chatter 5-point scale
Time frame: Screening, baseline, day 15, 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.
Epworth Sleepiness Scale
Time frame: Screening, baseline, day 15, day 30, day 60
How likely is the participant to doze off or fall asleep in the following situations? You should rate their chances of dozing off, not just feeling tired. Even if the participant has not done some of these things recently try to determine how it would have affected them. For each situation, decide whether or not the participant would have: · No chance of dozing =0 · Slight chance of dozing =1 · Moderate chance of dozing =2 · High chance of dozing =3 Write down the number corresponding to the choice in the right hand column. Interpretation: 0-7: It is unlikely that the participant is abnormally sleepy; 8-9: The participant has an average amount of daytime sleepiness; 10-15: The participant may be excessively sleepy depending on the situation. The participant may want to consider seeking medical attention; 16-24: The participant is excessively sleepy and should consider seeking medical attention.
ADHD Self-Report Scale (ASRS)
Time frame: Screening, baseline, day 15, day 30, day 60
The ASRS is an 18-item self-report screening scale used to assess adult ADHD. Each ASRS item contains a five-point scale where participants indicate how frequently they conduct themselves in the described manner; item responses can range from 'Never' to 'Very Often', where responses of 'Often' or 'Very Often' are consistent with ADHD typical dysfunction. When participant responses meet the criterion for ADHD typical dysfunction on at least 4 out of 6 screener items (denoted as 'Part A'), said participant will meet inclusion for the study. The remaining 12 ASRS items ('Part B') will be administered for use in the event that the screener criteria are met, and thus a need for further psychometric gradation arises.
COPE Questionnaire
Time frame: Screening, 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 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, 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.
Serum cortisol levels
Time frame: Screening, day 15 and day 60
The cortisol secretion will be evaluated by measuring morning serum cortisol levels.
ANTI-Vea-UGR computerized test
Time frame: 0 hours, 1 hours, 4 hours and 8 hours after dosing at day 1 and day 60
The Attentional Networks Test for Interactions and Vigilance-executive and arousal components (ANTI-Vea) is a computerized task. The task simultaneously assesses the main effects and interactions of the three attentional networks (i.e., phasic alertness, orienting, and executive control) and two dissociated components of vigilance with reasonable reliability (executive and arousal vigilance).
8 secondary outcomes
Safety of participant assessed using adverse events.
Time frame: Baseline, day 15, day 30, day 60
Safety of participant Assessed using treatment compliance and tolerability of investigational product
Time frame: Baseline, day 15, day 30, day 60
Systolic blood pressure difference from reference measurement (mmHg)
Time frame: Baseline, day 15, day 30, day 60
Diastolic blood pressure difference from reference measurement (mmHg)
Time frame: Baseline, day 15, day 30, day 60
Pulse rate difference from reference measurement (beats per minute)
Time frame: 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
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 Focus capsule- U001 and De-Stress and Focus capsule - I001 in people with Anxiety and Stress, 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 11 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 Baseline day 15 day 30 day 60). The study lists 14 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.