BefejeződöttFázis nélkül
A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
A legfontosabb adatok
- Ki végzi
- Second Affiliated Hospital of Nanchang University
- Hol
- Kína1 helyszín, 1 országbanVálassz országot a helyszínekhez
- Azonosító
- Állapot
- Befejeződött
- Résztvevők
- 30 fő vett részt
- Kezdés
- 2025. nov. 26.
- Befejezés
- 2026. jan. 12.
- A vizsgálat típusa
- Beavatkozással járó
- A vizsgált kezelések
- A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
- A regiszteradat frissítve
- 2026. október 27.
Ki vehet részt
- Életkor
- 18 év – 65 év
- Nem
- Nők és férfiak
- Egészséges önkéntesek
- Nem vehetnek részt
A regiszter feltételei, szó szerint
Mind a 7 feltétel megnézéseKevesebb
Ki nem vehet részt
- Acute myocardial infarction or interventional procedure within the past month. 3. History of severe gastrointestinal diseases, such as active ulcers or gastrointestinal bleeding; 4. History of severe respiratory diseases, such as chronic obstructive pulmonary disease, cor pulmonale, pulmonary interstitial fibrosis, etc.; 5. Hypertension that is not well controlled by medication: systolic blood pressure ≥ 150 mmHg or diastolic blood pressure ≥ 100 mmHg during the screening period. If the first measurement exceeds the limit, it can be repeated after at least 5 minutes on the same day. If three measurements still do not meet the criteria, the subject is ineligible; 6. Clinically diagnosed cerebrovascular accident or intracranial hemorrhage within 6 months; 7. History of moderate to severe sleep apnea, circadian rhythm sleep disorders, narcolepsy, restless legs syndrome, or sleep disorders secondary to other diseases; 8. History of complex sleep behaviors, such as previous episodes of driving, eating, or making phone calls during sleep; 9. Anxiety and/or depressive disorders, or insomnia requiring drug or other interventions during the trial; 10. Exclusion during screening if any of the following abnormalities are present:
- History of epilepsy, schizophrenia, bipolar and related disorders, intellectual disability, cognitive impairment, or any other neurological or psychiatric disorder that the investigator believes could affect the subject's safety or interfere with study assessments; 2. History of severe cardiovascular diseases meeting any of the following criteria:
- Heart failure (New York Heart Association functional class ≥ III)
- Unstable angina within the past 6 months
- Any arrhythmia requiring treatment
- QTc interval prolongation considered clinically significant by the investigator (reference range: men > 450 ms, women > 470 ms) (Note: QTc interval must be calculated according to Fridericia's formula)
- Platelets (PLT) < 100 × 10\^9/L, or hemoglobin (Hgb) < 90 g/L; 2) Liver function: AST or ALT > 3 × ULN, TBIL > 2 × ULN; 3) Renal function: serum creatinine > 2 × ULN. 11. History of severe allergic reactions (e.g., anaphylactic shock, laryngeal edema, severe bronchospasm); 12. High risk of suicide: suicide attempt within 1 year prior to screening; suicidal or self-harm behavior during screening; HAMD-17 item 3 (suicide) score ≥ 3; 13. History of abuse or addiction to relevant psychiatric medications; 14. Pregnant or breastfeeding women; 15. Participation in another drug clinical trial within 1 month prior to screening; 16. Any disease or condition that the investigator believes makes the subject unsuitable for participation in the clinical trial
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A vizsgálatról
Mit akar kideríteni a vizsgálat
The incidence of Mild Depressive Disorder Comorbid With Anxiety Disorder is dramatically increasing. dietary supplements may show better efficiency and less side effect.Here investigators intend to assess Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder.
A vizsgálat csoportja
- Participants with Mild Depressive Disorder Comorbid With Anxiety DisorderA vizsgált kezelés
Mild Depressive Disorder Comorbid With Anxiety Disorder
Kezelés: A Clinical Study Evaluating the Efficacy and Safety of CreNeuroS CNS Herbal Nutrition Capsules for Participants With Mild Depressive Disorder Comorbid With Anxiety Disorder
Adatok és források
- Regiszteradat
- Szerepel a ClinicalTrials.gov-on.
- A regiszteradat frissítve
- 2026. október 27.