Clinical trial NCT06569849: A Clinical Trial of De-stress and Focus Capsule in the Management of Stress.
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety
Stress
Stuporous
Keywords: stress
Mental alertness
Fatigue
Anxiety
Lead sponsor: Herbolab India Pvt. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, Double blind, Parallel Group, Placebo Controlled Trial
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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).

Eligibility criteria: Inclusion Criteria:

1. Male and female participants aged 18-50 years both inclusive
2. Suffering from self-reported mild to moderate stress on the PSS scale score less than or equal to 26
3. Scoring 18-26 on the Montreal Cognitive Assessment MoCA
4. No or minimal impairment in activities of daily living: scoring less than 9 on the Functional Activities Questionnaire FAQ
5. Participants willing to participate in clinical trials and who have read understood and signed the informed consent form
6. No severe anxiety and depression on GAD and PHQ-9 scales
7. Able to complete the cognitive assessment tests

Exclusion Criteria:

1. Inability to perform any of the assessments required for endpoint analysis
2. 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
3. Have any other neurodegenerative diseases
4. History of a seizure disorder
5. Known hypersensitivity to investigational products
6. Participants with a history of malignancy diagnosed within the past 5 years or currently diagnosed with malignancy
7. Sitting or resting systolic blood pressure of more than 180 mm Hg or diastolic blood pressure of more than 110 mm Hg at Screening.
8. Participants with a history of substance abuse, drugs, heavy use of alcohol, and/or smoking within the last 5 years
9. 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
10. Pregnant or lactating women, as well as women of childbearing potential who are not using contraception or intending to conceive during the study
11. 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

Primary outcomes:
measure: Perceived Stress Scale
timeFrame: Screening Baseline day 15 day 30 day 60
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Rey Complex Figure Test (RCFT)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Change in Trail Making Test (TMT) Between Baseline and End of Treatment
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Memory performance assessed using digit span memory test
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: fatigue severity scale (FSS)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: mental chatter 5-point scale
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: Epworth Sleepiness Scale
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: ADHD Self-Report Scale (ASRS)
timeFrame: Screening, baseline, day 15, day 30, day 60
measure: COPE Questionnaire
timeFrame: Screening, day 60
measure: STAI (State-Trait Anxiety Inventory)
timeFrame: Screening, day 60
measure: Profile of Mood State (POMS) questionnaire
timeFrame: Screening, day 60
measure: Serum cortisol levels
timeFrame: Screening, day 15 and day 60
measure: ANTI-Vea-UGR computerized test
timeFrame: 0 hours, 1 hours, 4 hours and 8 hours after dosing at day 1 and day 60
Secondary outcomes:
measure: Safety of participant assessed using adverse events.
timeFrame: Baseline, day 15, day 30, day 60
measure: Safety of participant Assessed using treatment compliance and tolerability of investigational product
timeFrame: Baseline, day 15, day 30, day 60
measure: Systolic blood pressure difference from reference measurement (mmHg)
timeFrame: Baseline, day 15, day 30, day 60
measure: Diastolic blood pressure difference from reference measurement (mmHg)
timeFrame: Baseline, day 15, day 30, day 60
measure: Pulse rate difference from reference measurement (beats per minute)
timeFrame: Baseline, day 15, day 30, day 60
measure: Complete blood count
timeFrame: Screening and day 60
measure: Serum Glutamic Pyruvic Transaminase (SGPT)
timeFrame: Screening and day 60
measure: serum glutamic-oxaloacetic transaminase (SGOT)
timeFrame: Screening and day 60
Other outcomes:
Locations:
Study officials:
affiliation: Lokmanya Medical Research Centre and Hospital
name: Dr. Ramshyam Agarwal, MBBS, DNB
role: PRINCIPAL_INVESTIGATOR
References: