💬In plain words
What the trial is, and whether it could suit you
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 par
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
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.
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