Clinical trial NCT06579183: Pilot Trial for Health Products in Psychological Distress and Insomnia
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Psychological Distress
Insomnia
Keywords: Psychological distress
Insomnia
Chinese medicine
Health product
Extra Strength VitaJoy
Extra Strength Vita Calm
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
First posted: 2024-08-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Psychological distress is a state of emotional suffering characterized by a combination of undifferentiated symptoms ranging from anxiety (e.g., restlessness), depression (e.g., loss of interest), stress, to functional impairment. Among these symptoms, anxiety and depression, which can be subclinical symptoms or clinical diagnoses, are highly comorbid. Somatic symptoms such as insomnia, lack of energy, and headache often accompany psychological distress, too.

Psychological distress can be a precursor and/ or feature of various mental disorders, where an individual's cognition, emotional regulation, or behavior is significantly disturbed. It is highly prevalent in the general population and has become more severe during and after the COVID-19 pandemic. The global prevalence of psychological distress with insomnia has dramatically risen since the COVID-19 pandemic, with 25.6% for anxiety, 23.1% for depression, and 17.4% for insomnia. In Hong Kong, 19% suffer from depression and 14% have anxiety. However, psychological distress and insomnia are often underdiagnosed and vastly undertreated because the condition of most individuals is mild, and some fear drugs would elicit undesirable side effects, which can sometimes be a greater risk than the disease itself. The development of novel alternative treatment strategies is therefore greatly desired.

The use of Chinese medicine and complementary medicine has gained increased attention in treating mental-related disorders in recent decades. A vast number of studies have suggested the benefits of Chinese medicines, vitamins, and amino acid supplementary products in improving anxiety, depression, and insomnia. It is possible that Chinese medicines, vitamins, and amino acids together can bring about beneficial synergistic effects in treating psychological distress 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. Chinese medicines of ES/VJ and ES/VC are developed based on traditional Chinese medicine theory, aligning with compatibility of traditional Chinese Medicine and following the basic Chinese medicine formula structure of "Jun-Chen-Zuo-Shi". 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. Although determination of synergistic effects between Chinese medicine, vitamins and amino acids is not addressed in this study due to time and resource limitations, results of our preliminary studies have encouraged us to further conduct a randomized controlled trial to confirm the effects and safety of the two products, in particular anxiety and depressive symptoms and insomnia alleviation.

Eligibility criteria: Inclusion Criteria:

Subjects will be eligible for this study if they:

1. are experiencing anxiety and/or depressive symptoms, as evidenced by a BAI-C score of at least 8 (no symptoms = 0-7; mild = 8-15; moderate = 16-25; severe = 26-63) and/or a C-BDI-II score of at least 14 (no symptoms = 0-13, mild = 14-19; moderate = 20-28; severe = 29-63), with symptoms persistent for more than 3 months; and
2. are able to provide informed consent for participation, take medications and complete questionnaires as scheduled.

Exclusion Criteria:

Subjects will be excluded if they:

1. have unstable systemic medical conditions that may limit their participation in the study (e.g., severe liver, cardiovascular or kidney impairment; gastrointestinal or endocrine dysfunction; malignancy; autoimmune disease or acute infectious disease);
2. have bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease), or significant cognitive impairment;
3. present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);
4. have a history of brain injury or surgery;
5. have alcohol abuse or substance abuse;
6. are pregnant or in lactation, or are intend to conceive;
7. have use of herbal remedies in the previous 6 months;
8. have a history of hypersensitivity to investigational drug treatment or the active or inactive constituents of the tested products;
9. have treatment with brain stimulation in the previous 6 months; or
10. are involved in other interventional clinical studies in the last 3 months or any relevant condition potentially interfering with study evaluation.

Primary outcomes:
measure: Change in the Beck Anxiety Inventory score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
Secondary outcomes:
measure: Change in the Beck Depression Inventory-II score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change in the Zung Self-Rating Anxiety Scale score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change in the Zung Self-Rating Depression Scale score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change in the Pittsburgh Sleep Quality Index score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
measure: Change in the World Health Organization Quality of Life-Brief (HK version) score
timeFrame: Baseline, Week 4, Week 8, Week 12, Week 16
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: The University of Hong Kong
Study officials:
affiliation: School of Chinese Medicine, The University of Hong Kong
name: Zhang-Jin Zhang, MMed, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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