Pilot Trial for Health Products on Mood and Sleep Quality

NCT06579183 | Not Yet Recruiting

• 1 other identifier: UW 24-183
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sleep Disturbance; Emotional Disturbance

Keywords

Chinese herbal medicine; supplement; sleep disturbance; emotional disturbance; mood

Outcome Measures

Primary Outcomes (1)

• 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).

  Baseline, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes (7)

• Change in the Beck Anxiety Inventory score

  Baseline, Week 4, Week 8, Week 12, Week 16

• Change in the Beck Depression Inventory-II score

  Baseline, Week 4, Week 8, Week 12, Week 16

• Change in the Perceived Stress Scale score

  Baseline, Week 4, Week 8, Week 12, Week 16

• Change in the General Health Questionnaire-28 score

  Baseline, Week 4, Week 8, Week 12, Week 16

• Change in the World Health Organization Quality of Life-Brief (HK version) score

  Baseline, Week 4, Week 8, Week 12, Week 16

Other Outcomes (16)

• Change in aspartate aminotransferase (AST)

  Baseline and Week 12

• Change in alanine aminotransferase (ALT)

  Baseline and Week 12

• Change in gamma-glutamyl transferase (GGT)

  Baseline and Week 12

Study Arms (2)

VCMBF+VCDSF

EXPERIMENTAL

Participants will be instructed to orally take 2 VCMBF capsules in the morning and 2 VCDSF capsules in the evening daily for 12 weeks. Participants will be advised to abstain from concomitant prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, and vaccines (except oral contraceptive pills).

Dietary Supplement: Vita Calm Mood Booster Formula (VCMBF); Dietary Supplement: Vita Calm Deep Sleep Formula (VCDSF)

Placebo

PLACEBO COMPARATOR

Participants will be instructed to orally take 4 placebo capsules daily (2 in the morning and 2 in the evening) for 12 weeks. Participants will be advised to abstain from concomitant prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, and vaccines (except oral contraceptive pills).

Dietary Supplement: Placebo

Interventions

Placebo DIETARY_SUPPLEMENT

Placebo Capsule, 4 capsules in the morning and evening respectively

Placebo

Vita Calm Mood Booster Formula (VCMBF) DIETARY_SUPPLEMENT

Vita Calm Mood Booster Formula (VCMBF) Capsule, 2 capsules in the morning

VCMBF+VCDSF

Vita Calm Deep Sleep Formula (VCDSF) DIETARY_SUPPLEMENT

Vita Calm Deep Sleep Formula (VCDSF) Capsule, 2 capsules in the evening

VCMBF+VCDSF

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants will be eligible for this study if they:
• 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.

You may not qualify if:

• Participants will be excluded if they:
• 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;
• have alcohol abuse (defined as ≥2 drinks per day) or substance abuse;
• are pregnant, in lactation, or intend to conceive during the six months preceding the beginning of the trial;
• 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;
• have a history of adverse reactions or known allergies to ingredients in the investigational products;
• are unable to ingest pills, or
• 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.

Sponsors & Collaborators

• The University of Hong Kong: lead
• Vita Green Health Products Co. Ltd: collaborator

Study Sites (1)

The University of Hong Kong

Hong Kong, Hong Kong, 000000, Hong Kong

Location

Related Publications (4)

• Morin CM, Bjorvatn B, Chung F, Holzinger B, Partinen M, Penzel T, Ivers H, Wing YK, Chan NY, Merikanto I, Mota-Rolim S, Macedo T, De Gennaro L, Leger D, Dauvilliers Y, Plazzi G, Nadorff MR, Bolstad CJ, Sieminski M, Benedict C, Cedernaes J, Inoue Y, Han F, Espie CA. Insomnia, anxiety, and depression during the COVID-19 pandemic: an international collaborative study. Sleep Med. 2021 Nov;87:38-45. doi: 10.1016/j.sleep.2021.07.035. Epub 2021 Aug 4.

  PMID: 34508986 BACKGROUND

• Choi EPH, Hui BPH, Wan EYF. Depression and Anxiety in Hong Kong during COVID-19. Int J Environ Res Public Health. 2020 May 25;17(10):3740. doi: 10.3390/ijerph17103740.

  PMID: 32466251 BACKGROUND

• Sarris J, Ravindran A, Yatham LN, Marx W, Rucklidge JJ, McIntyre RS, Akhondzadeh S, Benedetti F, Caneo C, Cramer H, Cribb L, de Manincor M, Dean O, Deslandes AC, Freeman MP, Gangadhar B, Harvey BH, Kasper S, Lake J, Lopresti A, Lu L, Metri NJ, Mischoulon D, Ng CH, Nishi D, Rahimi R, Seedat S, Sinclair J, Su KP, Zhang ZJ, Berk M. Clinician guidelines for the treatment of psychiatric disorders with nutraceuticals and phytoceuticals: The World Federation of Societies of Biological Psychiatry (WFSBP) and Canadian Network for Mood and Anxiety Treatments (CANMAT) Taskforce. World J Biol Psychiatry. 2022 Jul;23(6):424-455. doi: 10.1080/15622975.2021.2013041. Epub 2022 Mar 21.

  PMID: 35311615 BACKGROUND

• Sarris J, Marx W, Ashton MM, Ng CH, Galvao-Coelho N, Ayati Z, Zhang ZJ, Kasper S, Ravindran A, Harvey BH, Lopresti A, Mischoulon D, Amsterdam J, Yatham LN, Berk M. Plant-based Medicines (Phytoceuticals) in the Treatment of Psychiatric Disorders: A Meta-review of Meta-analyses of Randomized Controlled Trials: Les medicaments a base de plantes (phytoceutiques) dans le traitement des troubles psychiatriques: une meta-revue des meta-analyses d'essais randomises controles. Can J Psychiatry. 2021 Oct;66(10):849-862. doi: 10.1177/0706743720979917. Epub 2021 Feb 18.

  PMID: 33596697 BACKGROUND

MeSH Terms

Conditions

Parasomnias; Affective Symptoms

Condition Hierarchy (Ancestors)

Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Behavioral Symptoms; Behavior

Study Officials

• Zhang-Jin Zhang, MMed, PhD

  School of Chinese Medicine, The University of Hong Kong

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhang-Jin Zhang, MMed, PhD

CONTACT

+852 3917 6445; zhangzj@hku.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 28, 2024
• First Posted: August 30, 2024
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): September 1, 2028
• Last Updated: July 10, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)