Pilot Trial for Health Products in Psychological Distress and Insomnia

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, two-armed, 16 weeks, double-blinded, randomized, placebo-controlled trial. A total of 60 patients aged 18-65 with psychological distress will be recruited. They will be randomly assigned to receive a combination of ES/VJ and ES/VC, or placebos (30 each) for 12 weeks. A 4-week observational phase will follow, and a post-intervention visit will be held at week 16. Written informed consent forms are obtained prior to commencement of the study from each participant. The primary outcome will be assessed using the Chinese version of the Beck Anxiety Inventory (BAI-C). The secondary outcomes include the Chinese version of the Beck Depression Inventory II (C-BDI-II) for depression, the Zung Self-Rating Anxiety Scale (SAS) as an additional assessment that measures intensity of anxiety, the Zung Self-Rating Depression Scale (SDS) as an additional assessment that measures intensity of depression, the Pittsburgh Sleep Quality Index (PSQI) for sleep quality, and the World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) for the general quality of life. Safety profile of ES/VJ and ES/VC will also be evaluated. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.

Conditions

Psychological Distress; Insomnia

Keywords

Psychological distress; Insomnia; Chinese medicine; Health product; Extra Strength VitaJoy; Extra Strength Vita Calm

Outcome Measures

Primary Outcomes (1)

• Change in the Beck Anxiety Inventory score

  Beck Anxiety Inventory (BAI-C) is used to measure the severity of anxiety and its overall score ranges from 0 to 63. 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 (5)

• Change in the Beck Depression Inventory-II score

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

• Change in the Zung Self-Rating Anxiety Scale score

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

• Change in the Zung Self-Rating Depression Scale score

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

• Change in the Pittsburgh Sleep Quality Index 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

Study Arms (2)

ES/VJ+ES/VC

EXPERIMENTAL

Participants will be instructed to orally take ES/VJ and ES/VC capsules each day, and will continue their current medications as usual, including prescribed sleep pills, anxiolytics, and antidepressants, for 12 weeks.

Dietary Supplement: Extra Strength VitaJoy (ES/VJ); Dietary Supplement: Extra Strength Vita Calm (ES/VC)

Placebo

PLACEBO COMPARATOR

Participants will be instructed to orally take placebo capsules each day, and will continue their current medications as usual, including prescribed sleep pills, anxiolytics, and antidepressants, for 12 weeks.

Dietary Supplement: Placebo

Interventions

Extra Strength VitaJoy (ES/VJ) DIETARY_SUPPLEMENT

Extra Strength VitaJoy Capsule, 2 capsules in the morning

ES/VJ+ES/VC

Extra Strength Vita Calm (ES/VC) DIETARY_SUPPLEMENT

Extra Strength Vita Calm Capsule, 2 capsules in the evening

ES/VJ+ES/VC

Placebo DIETARY_SUPPLEMENT

Placebo Capsule, 4 capsules in the morning and evening respectively

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will be eligible for this study if they:
• are experiencing anxiety and/or depressive symptoms, as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63) and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63), with symptoms persistent for more than 3 months; and
• are able to provide informed consent for participation, take medications and complete questionnaires as scheduled.

You may not qualify if:

• Subjects will be excluded if they:
• have unstable systemic medical conditions that may limit their participation in the study (e.g., severe liver, cardiovascular or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease or acute infectious disease);
• have bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease), or significant cognitive impairment;
• present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);
• have a history of brain injury or surgery;
• have alcohol abuse or substance abuse;
• are pregnant or in lactation, or are intend to conceive;
• have use of herbal remedies in the previous 6 months;
• have a history of hypersensitivity to investigational drug treatment or the active or inactive constituents of the tested products;
• have treatment with brain stimulation in the previous 6 months; or
• are involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.

Sponsors & Collaborators

• The University of Hong Kong: lead

Study Sites (1)

The University of 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

Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

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: TREATMENT
• 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: June 1, 2025
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

HK (1)