psychological subhealth in adults (depressive and anxious moods)
Conditions
Interventions
High-dose group:CreNeuroS? CNS Fish Oil Plus Softgels is administered as 4 tablets daily (1.048 g per tablet), with 2 tablets in the morning and 2 in the evening, for 6 consecutive weeks.
Low-dose group:1 softgel of CreNeuroS? CNS Fish Oil Plus Softgels (1.048 g per softgel) and 3 placebo softgels are administered daily, with 2 softgels taken in the morning and 2 in the evening, for 6
Medium-dose group:2 softgel of CreNeuroS? CNS Fish Oil Plus Softgels (1.048 g per softgel) and 2 placebo softgels are administered daily, with 2 softgels taken in the morning and 2 in the evening, for
Placebo group:Four placebo softgels (1.048 g per softgel, containing no dietary ingredients) are administered daily, with 2 softgels taken in the morning and 2 in the evening, for 6 consecutive weeks.
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
20 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged 20 years or older, no gender restriction; 2. Subjects are classified as mild to severe psychological subhealth (MS) based on the Psychological Subhealth Subscale of the Subhealth Rating Scale. In accordance with the scoring criteria of the normative cut-off values for the psychological subhealth dimension of the Subhealth Rating Scale for urban residents in China, the converted dimension scores are specified as follows: Males: 20–29 years old: 52.24–81.25 points 30–49 years old: 53.40–83.48 points 50–64 years old: 52.38–82.90 points >= 65 years old: 51.63–81.08 points Females: 20–29 years old: 50.47–78.23 points 30–49 years old: 51.13–80.75 points 50–64 years old: 51.34–81.19 points >= 65 years old: 49.14–78.57 points; 3. Total score of the Generalized Anxiety Disorder-7 (GAD-7) <= 9 points; 4. Total score of the 9-item Patient Health Questionnaire (PHQ-9) <= 9 points; 5. Present with depressive or anxious mood, and do not meet the diagnostic criteria for depressive disorder and/or anxiety disorder as defined by ICD-10; 6. Able to fully understand the trial requirements, volunteer to participate in this trial, and provide written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects with past or current diagnosis of depression, anxiety disorder, schizophrenia or other psychiatric disorders; 2. Subjects currently receiving antidepressant, anxiolytic, antipsychotic or other treatments for psychiatric diseases (including psychotherapy); 3. Subjects assessed by investigators to have suicidal ideation; 4. Subjects with a history of drug and/or alcohol abuse within 6 months prior to screening; 5. Subjects with current or previous diseases of the nervous, cardiovascular, respiratory, digestive, renal, hepatic, hematological, endocrine or other organ systems, which, as judged by the investigator or medical monitor, may compromise subject safety, interfere with trial conduct or confound interpretation of trial results, including but not limited to: (1) Subjects with a history of epilepsy; (2) Subjects with a history of severe heart disease, myocardial infarction, unstable angina, acute coronary syndrome or stroke, or with known personal or family history of sudden cardiac death; (3) Subjects with atrial fibrillation requiring ongoing anticoagulant therapy; (4) Subjects with a history of asthma; (5) Subjects with untreated acute or chronic gastric ulcer, or Crohn’s disease at screening; (6) Subjects with known hepatic or renal insufficiency, or with clinically significant abnormal liver or renal laboratory parameters at screening as judged by investigators (e.g., ALT or AST > 2× upper limit of normal (ULN), or creatinine exceeding ULN by more than 20%); (7) Subjects with hypothyroidism indicated by laboratory tests of thyroid-stimulating hormone (TSH) and thyroxine (T4); (8) Subjects with a history of malignant tumors. 6. Subjects who have participated in any other non-interventional clinical trial within 3 months prior to screening, or are currently enrolled in any interventional clinical trial involving investigational products, marketed drugs or medical devices; 7. Subjects currently taking fish oil, n-3 PUFAs supplements, folic acid or L-5-methyltetrahydrofolate; or subjects with known hypersensitivity to fish oil, folic acid, L-5-methyltetrahydrofolate, or non-dietary ingredients contained in the test product; 8. Subjects consuming fish = 3 times per week in the past 3 months, or taking fish oil, n-3 PUFAs supplements, folic acid or L-5-methyltetrahydrofolate within the past 6 months; 9. Pregnant women, women planning pregnancy, fertile women unwilling to use effective contraception throughout the trial and for 3 months after the last dose of test product, and breastfeeding women; 10. Subjects deemed unsuitable for this trial by the investigator for any other reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the score of the Psychological Subhealth (MS) dimension of the Sub-Health Measurement Scale Version 1.0 (SHMS V1.0); | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in the 7-item Generalized Anxiety Disorder Scale (GAD-7) score.;Change from baseline in the Pittsburgh Sleep Quality Index (PSQI) score.;Change from baseline in the Patient Health Questionnaire-9 (PHQ-9) score.;Adverse events; | — |
Countries
China
Contacts
Public ContactWang Xue
West China Hospital of Sichuan University
Outcome results
None listed