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Pilot Trial for Health Products in Psychological Distress and Insomnia
Sponsor: The University of Hong Kong
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
Conditions
Interventions
Extra Strength VitaJoy (ES/VJ)
Extra Strength VitaJoy Capsule, 2 capsules in the morning
Extra Strength Vita Calm (ES/VC)
Extra Strength Vita Calm Capsule, 2 capsules in the evening
Placebo
Placebo Capsule, 4 capsules in the morning and evening respectively
Locations (1)
The University of Hong Kong
Hong Kong, Hong Kong