Clinical Trial for Health Products in Emotional Disorders and Insomnia
NCT Number: NCT06579183
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Emotional; Disorder|Insomnia
Interventions: DIETARY_SUPPLEMENT: Extra Strength VitaJoy (ES/VJ)|DIETARY_SUPPLEMENT: Extra Strength Vita Calm (ES/VC)|DIETARY_SUPPLEMENT: Placebo
Sponsor: The University of Hong Kong
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 60
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-12
Completion Date: 2027-12
Locations: The University of Hong Kong, Hong Kong, 000000, Hong Kong

Summary:
This is a pilot, double-blinded, randomized placebo-controlled trial. A total of 60 patients aged 18-65 with emotional disorders will be recruited. They will be randomly assigned to receive placebo, Extra Strength VitaJoy (ES/VJ), and Extra Strength Vita Calm (ES/VC) (30 each) for 12 weeks. ES/VJ and ES/VC are two health products that are formulated by combining Chinese medicines, multiple vitamins and amino acids. Please refer to the study protocol for the formula of the two products. The primary outcome will be assessed using the Beck Anxiety Inventory (BAI). The secondary outcomes include the Beck Depression Inventory II (BDI-II) for 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. A generalized linear mixed-effect model will be applied to compare treatment outcomes over time in the 2 groups.

Primary Outcome Measures: Change in the Beck Anxiety Inventory score, Beck Anxiety Inventory (BAI) 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 6 and week 12., Baseline, Week 6 and Week 12
Secondary Outcome Measures: Change in the Beck Depression Inventory-II score, Beck Depression Inventory-II (BDI-II) is used to measure the severity of depression and its overall score ranges from 0 to 63. A higher score indicates greater severity. Assessments will be conducted at baseline, week 6 and week 12., Baseline, Week 6 and Week 12|Change in the Pittsburgh Sleep Quality Index score, Pittsburgh Sleep Quality Index (PSQI) is used to assess sleep quality and its overall score ranges from 0 to 21. A higher score indicates more acute sleep disturbances. Assessments will be conducted at baseline, week 6 and week 12., Baseline, Week 6 and Week 12|Change in the World Health Organization Quality of Life-Brief (HK version) score, World Health Organization Quality of Life-Brief (WHOQOL-BREF) (HK version) is used to assess quality of life, with four quality of life domains: physical health (7 items), psychological health (6 items), social relationships (3 items), and environmental health (8 items). Each individual item is scored from 1 to 5 on a response scale, which is stipulated as a five-point ordinal scale. The scores are then transformed linearly to a 0-100-scale. A higher score indicates better quality of life. Assessments will be conducted at baseline, week 6 and week 12., Baseline, Week 6 and Week 12