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NOT YET RECRUITING
NCT06579183
NA

Pilot Trial for Health Products in Psychological Distress and Insomnia

Sponsor: The University of Hong Kong

View on ClinicalTrials.gov

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.

Official title: A Pilot Randomized, Double-blinded, Placebo-controlled Trial on the Effects and Safety of Health Products Combining Traditional Chinese Medicines, Vitamins and Amino Acids in Psychological Distress and Insomnia

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2025-06

Completion Date

2028-12

Last Updated

2025-05-20

Healthy Volunteers

No

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

Locations (1)

The University of Hong Kong

Hong Kong, Hong Kong