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Pilot Trial for Health Products in Psychological Distress and Insomnia

NCT06579183 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-20

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Extra Strength VitaJoy (ES/VJ)

Extra Strength VitaJoy Capsule, 2 capsules in the morning

DIETARY_SUPPLEMENT

Extra Strength Vita Calm (ES/VC)

Extra Strength Vita Calm Capsule, 2 capsules in the evening

DIETARY_SUPPLEMENT

Placebo

Placebo Capsule, 4 capsules in the morning and evening respectively

Sponsors & Collaborators

  • The University of Hong Kong

    lead OTHER

Principal Investigators

  • Zhang-Jin Zhang, MMed, PhD · School of Chinese Medicine, The University of Hong Kong

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-30
Primary Completion
2027-12-31
Completion
2028-12-31

Countries

  • Hong Kong

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06579183 on ClinicalTrials.gov