A Randomized, Double-blinded, Placebo-controlled Trial to Evaluate Chinese Herbal Medicines, Multivitamins and Amino Acid-containing Supplements on Mood and Sleep Quality
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in the Beck Anxiety Inventory score
研究概览
简要总结
This is a pilot, single-site clinical trial that will follow a randomized, double-blinded, parallel-group, placebo-controlled design. A total of 60 participants aged 18-65 will be recruited for a 12-week intervention, followed by a 4-week observational phase and a post-intervention visit at week 16. Participants will attend five scheduled visits at 4-week intervals (baseline, weeks 4, 8, 12, and 16) at the Specialist Clinical Centre for Teaching and Research, School of Chinese Medicine, the University of Hong Kong (HKUSCM). At each visit, assessments will include psychological attributes and sleep quality. Participants will be randomly allocated to one of 2 groups (n=30 per group): the intervention group, which will receive VCMBF and VCDSF, and the control group, which will receive a placebo matched for appearance, smell, and taste. Written informed consent will be obtained from each participant prior to the commencement of the study.
The primary outcome will be overall mental health, accessed by the Depression, Anxiety and Stress Scale - 21 items (DASS-21). Secondary outcomes will include anxiety status, measured by the Chinese version of the Beck Anxiety Inventory (BAI-C); depression status, measured by the Chinese version of the Beck Depression Inventory-II (C-BDI-II); stress levels, measured by the Perceived Stress Scale (PSS); psychological well-being, measured by the General Health Questionnaire-28 (GHQ-28); quality of life, assessed using the WHOQOL-BREF (Hong Kong version); and sleep quality, assessed using the Pittsburgh Sleep Quality Index (PSQI), the Mi wristband as an objective measure, and the Consensus Sleep Diary (CSD) for cross-validation. Tongue and pulse characteristics will also be recorded for qualitative analysis. Safety profiles of VCMBF and VCDSF will be evaluated throughout the study. Assessments will occur every four weeks until week 16, with tongue and pulse characteristics recorded at baseline, week 12, and week 16. A generalized linear mixed-effect model will be applied to compare outcomes over time in the 2 groups.
详细描述
Mental health issues and sleep disorders have surged globally, especially after COVID-19. In a study analysing over 13 countries throughout the world, rates of anxiety, depression, and insomnia are 25.6%, 23.1%, and 17.4%, respectively. In Hong Kong, 19% suffer from depression, and 14% have anxiety. More generalized symptoms of psychological distress and sleep disturbance are at even higher levels. The overall prevalences for stress, anxiety symptoms, and depressive symptoms are 21.9%, 20.7%, and 17.4%, respectively, in Hong Kong.
Psychological distress is a subclinical state of emotional suffering encompassing anxiety symptoms, depressive symptoms, stress, and functional impairment. Though highly prevalent in the general population, these subtle, milder-than-clinical syndrome manifestations are often unrecognized and untreated, affecting individuals' mental well-being and quality of life significantly and, in time, adding to healthcare costs. Identification of potential protective factors against psychological distress is therefore important.
Sleep and mental well-being are closely related. Somatic symptoms such as sleep disturbance, fatigue, and headache often accompany psychological distress. Sleep, on the other hand, is critical in maintaining physical and psychological well-being, including emotional regulation. Insufficient and poor sleep contributes to higher levels of negative mood and prolonged sleep impairment is associated with depression. Thus, sleep and psychological distress share a bidirectional relationship. Poor sleep can increase psychological distress, while psychological distress can cause and/or worsen sleep issues.
Sleep disturbance and psychological distress, being closely associated, should therefore be considered holistically. Individuals with suboptimal mental well-being states and sleep quality below the threshold for clinical diagnosis often lack options for effective intervention. There is still an unmet need for safe and accessible aids for them, and identification of safe and accessible alternative interventions that improve mood and sleep is greatly desired.
The use of Chinese medicine, vitamins, herbs and other natural compounds that offer health-promoting properties has gained increased attention in recent years, in particular aiding mood, sleep, and psychological symptoms. A vast number of studies have suggested the benefits of Chinese medicines, vitamins, and amino acid supplementary products in improving symptoms of anxiety, depression, and sleep quality. For instance, vitamin B12 deficiency is found to be associated with a higher incidence of depressive mood. L-theanine is found to exert positive effects on relaxation, sleep quality, and mood. It is possible that Chinese medicines, vitamins, and amino acids together can bring about beneficial synergistic effects in improving mood and sleep quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Participants will be eligible for this study if they:
- •are aged 18-65 years;
- •have basic Chinese and/or English reading comprehension and expression abilities, and can complete the questionnaire survey independently; and
- •are willing and capable of providing signed informed consent; understand and are willing to comply with all study procedures, requirements, and restrictions as listed in the trial protocol and informed consent form; and complete testing and follow-up.
排除标准
- •Participants will be excluded if they:
- •have unstable systemic medical conditions and/or surgical history that may limit their participation in the study (e.g., severe organ failure, malignancy, neurological conditions, significant cognitive impairment, history of head trauma or surgery, or kidney, liver, or gastrointestinal conditions that might impair food metabolism);
- •have a current or past history of an anxiety disorder, major depressive disorder, schizophrenia, bipolar disorder, insomnia, or any other psychiatric illnesses according to the Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-5);
- •present suicidal ideation (a score of ≥3 for all questionnaires of the Columbia-Suicide Severity Rating Scale (C-SSRS);
- •have recent involvement in psychotherapy (e.g., cognitive behavioral therapy, interpersonal psychotherapy, psychodynamic psychotherapy, etc.) and/or behavioral interventions 4 weeks prior to and throughout the study; and/or use of psychiatric medications (e.g., anxiolytic medications, antidepressant medications, etc.) or medications with central nervous system activation (e.g., anticholinergic drugs, acetylcholinesterase inhibitors, etc.) 12 weeks prior to and throughout the study;
- •have alcohol abuse (defined as ≥2 drinks per day) or substance abuse;
- •are pregnant, in lactation, or intend to conceive during the six months preceding the beginning of the trial;
- •are unwilling to abstain from concomitant unnecessary prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, or vaccines (except oral contraceptive pills) at least 4 weeks prior to and throughout the study, which might interfere with study outcomes;
- •have a history of adverse reactions or known allergies to ingredients in the investigational products;
- •are unable to ingest pills, or
- •are currently participating in or have participated in a program, treatment plan, or research study involving oral administration of investigational product(s) and/or diet, lifestyle modification 4 weeks prior to and throughout the study.
研究组 & 干预措施
Placebo
Participants will be instructed to orally take 4 placebo capsules daily (2 in the morning and 2 in the evening) for 12 weeks. Participants will be advised to abstain from concomitant prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, and vaccines (except oral contraceptive pills).
干预措施: Placebo (Dietary Supplement)
VCMBF+VCDSF
Participants will be instructed to orally take 2 VCMBF capsules in the morning and 2 VCDSF capsules in the evening daily for 12 weeks. Participants will be advised to abstain from concomitant prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, and vaccines (except oral contraceptive pills).
干预措施: Vita Calm Deep Sleep Formula (VCDSF) (Dietary Supplement)
VCMBF+VCDSF
Participants will be instructed to orally take 2 VCMBF capsules in the morning and 2 VCDSF capsules in the evening daily for 12 weeks. Participants will be advised to abstain from concomitant prescription or over-the-counter medications, herbal extracts, vitamins, dietary supplements, illicit or recreational drugs, and vaccines (except oral contraceptive pills).
干预措施: Vita Calm Mood Booster Formula (VCMBF) (Dietary Supplement)
结局指标
主要结局
Change in the Beck Anxiety Inventory score
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16
Beck Anxiety Inventory (BAI-C) 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 4, week 8, week 12 and week 16 (post-intervention visit).
Change in the Depression, Anxiety and Stress Scale-21 items score
时间窗: Baseline, Week 4, Week 8, Week 12, Week 16
Depression, Anxiety and Stress Scale-21 items (DASS-21) assesses the severity of depression, anxiety, and stress components. It includes three subscales-depression, anxiety, and stress-with 7 items each, and yields three subscale scores for depression, anxiety, and tension/stress. A higher score indicates greater severity. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).
次要结局
- Change in the Beck Depression Inventory-II score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the Zung Self-Rating Anxiety Scale score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the Zung Self-Rating Depression Scale score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the Pittsburgh Sleep Quality Index score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the World Health Organization Quality of Life-Brief (HK version) score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the Beck Anxiety Inventory score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the Perceived Stress Scale score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the General Health Questionnaire-28 score(Baseline, Week 4, Week 8, Week 12, Week 16)
- Change in the sleep-wake patterns, sleep duration, and sleep stages(Baseline, Week 4, Week 8, Week 12, Week 16)
研究者
Prof. Zhang Zhang-Jin
Professor
The University of Hong Kong