Pilot Trial for Health Products on Mood and Sleep Quality

ConditionsSleep Disturbance Emotional Disturbance

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-65

SponsorThe University of Hong Kong

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

are aged 18-65 years;

have basic Chinese and/or English reading comprehension and expression abilities, and can complete the questionnaire survey independently; and

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.

Disqualifiers

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);

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);

present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: VCMBF+VCDSFExperimental treatment 2 interventions

Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

Change in the Depression, Anxiety and Stress Scale-21 items score

Depression, Anxiety and Stress Scale-21 items (DASS-21) assesses the severity of depression, anxiety, and stress components. It includes three subscales-depression, anxiety, and stress-with 7 items each, and yields three subscale scores for depression, anxiety, and tension/stress. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).

Time frame