保健品治疗情绪障碍和失眠的临床试验

实验性的：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).

膳食补充剂：Vita Calm Mood Booster Formula (VCMBF)

Vita Calm Mood Booster Formula (VCMBF) Capsule, 2 capsules in the morning

膳食补充剂：Vita Calm Deep Sleep Formula (VCDSF)

Vita Calm Deep Sleep Formula (VCDSF) Capsule, 2 capsules in the evening

安慰剂比较：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).

膳食补充剂：安慰剂

安慰剂胶囊，早晚各 4 粒

Change in the Depression, Anxiety and Stress Scale-21 items score

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).

改变贝克焦虑量表评分

Beck焦虑量表（BAI-C）用于衡量焦虑的严重程度及其整体评分范围为0至63。 更高的分数表明严重程度更大。 评估将在基线，第4周，第8周，第12周和第16周（干预后访问）进行。

更改贝克抑郁库存-II分数

贝克抑郁量表II（C-BDI-II）用于衡量抑郁症的严重程度及其整体评分范围为0至63。 更高的分数表明严重程度更大。 评估将在基线，第4周，第8周，第12周和第16周（干预后访问）进行。

更改匹兹堡睡眠质量指数分数

匹兹堡睡眠质量指数（PSQI）用于评估睡眠质量，其总分范围为0到21。 更高的分数表明更多的急性睡眠障碍。 评估将在基线，第4周，第8周，第12周和第16周（干预后访问）进行。

改变世界卫生组织质量生命质量（HK版本）分数的变化

世界卫生组织的生命质量（WHOQOL-BREF）（HK版本）用于评估生活质量，具有四个生活质量领域：身体健康（7个项目），心理健康（6个项目），社会关系（3个项目）和环境健康（8个项目）。 每个单独的项目在响应量表上的评分为1到5，该响应量表被规定为五点序数尺度。 然后将分数线性转换为0-100尺度。 更高的分数表明生活质量更好。 评估将在基线，第6周和第12周进行。

Change in the Perceived Stress Scale score

Perceived Stress Scale (PSS) is a 10-item questionnaire measuring levels of perceived stress and its overall score ranges from 0 to 40. 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 General Health Questionnaire-28 score

General Health Questionnaire-28 (GHQ-28) is designed for use in assessing general mild psychiatric symptoms experienced over the past week using 28 items relevant to health-related quality of life, with a total possible score on the ranging from 0 to 84. A higher score indicates greater distress. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).

Change in the sleep-wake patterns, sleep duration, and sleep stages

Consensus Sleep Diary (CSD) is a standardized daily sleep diary self-reported by participants measuring sleep quality, sleep duration, and sleep latency that will cross-examine the Mi wristband data. Participants will wear a Mi wristband (Model: Xiaomi Band 9 Active) during sleep throughout the study to track and record sleep-wake patterns, sleep duration, and sleep stages. Sleep data will be synchronized to a secure, encrypted database via the Mi Fit application. Assessments will be conducted at baseline, week 4, week 8, week 12 and week 16 (post-intervention visit).

Change in aspartate aminotransferase (AST)

Aspartate aminotransferase (AST, U/L), an item in liver function test, is assessed as safety outcomes.

Change in alanine aminotransferase (ALT)

Alanine aminotransferase (ALT, U/L), an item in liver function test, is assessed as safety outcomes.

Change in gamma-glutamyl transferase (GGT)

Gamma-glutamyl transferase (GGT, U/L), an item in liver function test, is assessed as safety outcomes.

Change in alkaline phosphatase

Alkaline phosphatase (U/L), an item in liver function test, is assessed as safety outcomes.

Change in direct bilirubin

Direct bilirubin (μmol/L), an item in liver function test, is assessed as safety outcomes.

Change in total bilirubin

Total bilirubin (μmol/L), an item in liver function test, is assessed as safety outcomes.

Change in total protein

Total protein (g/L), an item in liver function test, is assessed as safety outcomes.

Change in albumin

Albumin (g/L), an item in liver function test, is assessed as safety outcomes.

Change in globulin

Globulin (g/L), an item in liver function test, is assessed as safety outcomes.

Change in albumin/globulin ratio

Albumin/globulin ratio, an item in liver function test, is assessed as safety outcomes.

Change in sodium

Sodium (mmol/L), an item in renal function test, is assessed as safety outcomes.

Change in potassium

Potassium (mmol/L), an item in renal function test, is assessed as safety outcomes.

Change in chloride

Chloride (mmol/L), an item in renal function test, is assessed as safety outcomes.

Change in urea

Urea (mmol/L), an item in renal function test, is assessed as safety outcomes.

Change in creatinine

Creatinine (μmol/L), an item in renal function test, is assessed as safety outcomes.

Change in estimated glomerular filtration rate

Estimated glomerular filtration rate (eGFR, ml/min), an item in renal function test, is assessed as safety outcomes.