PILOT TEST OF VITA CALM PRODUCTS FOR MOOD AND SLEEP

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a randomized, double-blind, placebo-controlled pilot study at a single site. It will enroll 60 adults aged 18-65 and assign them to either the Vita Calm Mood Booster Formula plus Deep Sleep Formula or a matched placebo for 12 weeks, followed by a 4-week observational period and a final visit at week 16. Participants will have visits every four weeks to assess mental health and sleep quality. The primary outcome is overall mental health, with additional sleep and mood measures collected through questionnaires and assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• School of Chinese Medicine University of Hong Kong
  Hong Kong, Hong Kong, Hong Kong Recruiting

Study contacts

• Principal investigator: Zhang-Jin Zhang, MMed, PhD — The University of Hong Kong
• Study coordinator: Zhang-Jin Zhang, MMed, PhD
• Email: zhangzj@hku.hk
• Phone: +852 3917 6445

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.