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

Overview

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).

Interventions

• Other De-Stress and Focus capsule- U001
  Two capsules in sequence daily after meal for 60 days.
• Other De-Stress and Focus capsule - I001
  Two capsules in sequence daily after meal for 60 days.
• Other Placebo capsules 001
  Two capsules in sequence daily after meal for 60 days.

Primary outcome measures

• Perceived Stress Scale [Time frame: Screening Baseline day 15 day 30 day 60]
• Montreal Cognitive Assessment (MoCA) [Time frame: Screening, baseline, day 15, day 30, day 60]
• Rey Complex Figure Test (RCFT) [Time frame: Screening, baseline, day 15, day 30, day 60]
• Change in Trail Making Test (TMT) Between Baseline and End of Treatment [Time frame: Screening, baseline, day 15, day 30, day 60]
• Memory performance assessed using digit span memory test [Time frame: Screening, baseline, day 15, day 30, day 60]
• fatigue severity scale (FSS) [Time frame: Screening, baseline, day 15, day 30, day 60]
• mental chatter 5-point scale [Time frame: Screening, baseline, day 15, day 30, day 60]
• Epworth Sleepiness Scale [Time frame: Screening, baseline, day 15, day 30, day 60]
• ADHD Self-Report Scale (ASRS) [Time frame: Screening, baseline, day 15, day 30, day 60]
• COPE Questionnaire [Time frame: Screening, day 60]

Secondary outcome measures (8)

• 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]

Eligibility criteria

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Supportive care

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06569849 · MHC/CT/24-25/017 · CTRI/2024/07/071243

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗