Clinical Trial for Health Products in Emotional Disorders and Insomnia

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.

Emotional disorders are generally referred to as coexisting anxiety and depression as core symptoms, often accompanied by physical and sleep problems. Emotional disorders and insomnia are highly prevalent in the general population. This has become more severe during and after the COVID-19 pandemic, and the global prevalence of emotional disorders with insomnia has dramatically risen since the COVID-19 pandemic, with 17.4% for insomnia, 25.6% for anxiety, and 23.1% for depression. In Hong Kong, 19% suffer from depression and 14% have anxiety. However, emotional disorders and insomnia are often underdiagnosed and vastly undertreated because the condition of most individuals is mild, and they fear drugs' side effects, which sometimes are a greater risk than the disease itself. The development of novel alternative treatment strategies is therefore greatly desired.

A vast number of studies have suggested the benefits of Chinese medicines, vitamins, and amino acid supplementary products in improving anxiety, depression, and insomnia. Extra Strength VitaJoy (ES/VJ) and Extra Strength Vita Calm (ES/VC) are two health products that are formulated by combining Chinese medicines, multiple vitamins and amino acids. The two products are thought to tranquilize anxiety and nervousness, relieve sadness and depression, and improve sleeplessness. Our preliminary animal studies have suggested that Chinese medicines of ES/VJ noticeably reduced depression-like behavior in animal models, probably via the modulation of monoamine oxidase (MAO), without inducing herb-drug interaction or hypertension. Chinese medicines of ES/VC rapidly induced sleep in animals and reduced anxiety, and their efficacy was comparable to that of benzodiazepines. A pilot clinical observation revealed that Chinese medicine preparation of ES/VC could improve multiple sleep variables recorded by Actiwatch and diary. Results of our preliminary studies have encouraged us to further conduct a randomized controlled trial to confirm the efficacy of the two products.

Eligibility Criteria:
Inclusion Criteria:

* are experiencing anxiety and/or depression, as evidenced by a BAI score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63) and/or a BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63); and
* have no suicidal ideation, as evidenced by "no" answers or a score of \<3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS).

Exclusion Criteria:

* with unstable medical conditions that may limit their participation in the study;
* with a history of brain injury or surgery;
* are pregnant or in lactation;
* with investigational drug treatment in the previous 6 months; or
* have treatment with brain stimulation in the previous 6 months.