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Pilot Trial for Health Products on Mood and Sleep Quality

Sponsor: The University of Hong Kong • ClinicalTrials.gov ID: NCT06579183

Registry updated: 2026-10-02

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Description

This is a pilot, single-site clinical trial that will follow a randomized, double-blinded, parallel-group, placebo-controlled design. A total of 60 participants aged 18-65 will be recruited for a 12-week intervention, followed by a 4-week observational phase and a post-intervention visit at week 16. Participants will attend five scheduled visits at 4-week intervals (baseline, weeks 4, 8, 12, and 16) at the Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, the University of Hong Kong (HKUSCM). At each visit, assessments will include psychological attributes and sleep quality. Participants will be randomly allocated to one of 2 groups (n=30 per group): the intervention group, which will receive VCMBF and VCDSF, and the control group, which will receive a placebo matched for appearance, smell, and taste. Written informed consent will be obtained from each participant prior to the commencement of the study. The primary outcome will be overall mental health, accessed by the Depression, Anxiety and Stress Scale - 21 items (DASS-21). Secondary outcomes will include anxiety status, measured by the Chinese version of the Beck Anxiety Inventory (BAI-C); depression status, measured by the Chinese version of the Beck Depression Inventory-II (C-BDI-II); stress levels, measured by the Perceived Stress Scale (PSS); psychological well-being, measured by the General Health Questionnaire-28 (GHQ-28); quality of life, assessed using the WHOQOL-BREF (Hong Kong version); and sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), the Mi wristband as an objective measure, and the Consensus Sleep Diary (CSD) for cross-validation. Tongue and pulse characteristics will also be recorded for qualitative analysis. Safety profiles of VCMBF and VCDSF will be evaluated throughout the study. Assessments will occur every four weeks until week 16, with tongue and pulse characteristics recorded at baseline, week 12, and week 16. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.

Interventions

Vita Calm Mood Booster Formula (VCMBF) (Dietary supplement)
Vita Calm Mood Booster Formula (VCMBF) Capsule, 2 capsules in the morning
Vita Calm Deep Sleep Formula (VCDSF) (Dietary supplement)
Vita Calm Deep Sleep Formula (VCDSF) Capsule, 2 capsules in the evening
Placebo (Dietary supplement)
Placebo Capsule, 4 capsules in the morning and evening respectively

Eligibility criteria

Inclusion Criteria: Participants will be eligible for this study if they: 1. are aged 18-65 years; 2. have basic Chinese and/or English reading comprehension and expression abilities, and can complete the questionnaire survey independently; and 3. are willing and capable of providing signed informed consent; understand and are willing to comply with all study procedures, requirements, and restrictions as listed in the trial protocol and informed consent form; and complete testing and follow-up. Exclusion criteria: Participants will be excluded if they: 1. have unstable systemic medical conditions and/or surgical history that may limit their participation in the study (e.g., severe organ failure, malignancy, neurological conditions, significant cognitive impairment, history of head trauma or surgery, or kidney, liver, or gastrointestinal conditions that might impair food metabolism); 2. have a current or past history of an anxiety disorder, major depressive disorder, schizophrenia, bipolar disorder, insomnia, or any other psychiatric illnesses according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5); 3. present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS); 4. have recent involvement in psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy, etc.) and/or behavioral interventions 4 weeks prior to and throughout the study; and/or use of psychiatric medications (e.g., anxiolytic medications, antidepressant medications, etc.) or medications with central nervous system activation (e.g., anticholinergic drugs, acetylcholinesterase inhibitors, etc.) 12 weeks prior to and throughout the study; 5. have alcohol abuse (defined as ≥2 drinks per day) or substance abuse; 6. are pregnant, in lactation, or intend to conceive during the six months preceding the beginning of the trial; 7. are unwilling to abstain from concomitant unnecessary prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, or vaccines (except oral contraceptive pills) at least 4 weeks prior to and throughout the study, which might interfere with study outcomes; 8. have a history of adverse reactions or known allergies to ingredients in the investigational products; 9. are unable to ingest pills, or 10. are currently participating in or have participated in a program, treatment plan, or research study involving oral administration of investigational product(s) and/or diet, lifestyle modification 4 weeks prior to and throughout the study.

Conditions

Sleep Disturbance Emotional Disturbance

Locations

School of Chinese Medicine University of Hong Kong — Hong Kong, Hong Kong, Hong Kong

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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