Chronic insomnia
Conditions
Interventions
Experimental group:360mg per capsule, take 2 capsules once daily with water after lunch.
Sponsors
Shanghai Tenth People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18–65 years inclusive, no gender restrictions; 2. Meets ICSD-3 diagnostic criteria for chronic insomnia disorder [Appendix 1]; 3. ISI (Insomnia Severity Index) total score of 8–21 points inclusive during screening [Appendix 2]; 4. Educational attainment =6 years; 5. Able to read Chinese and accurately comprehend the trial procedures, voluntarily participating in the trial and having signed the informed consent form; 6. Able to cooperate with and attend scheduled follow-up appointments, promptly report any changes in personal health status or dietary intake, adverse reaction symptoms, and comply with study requirements and timelines.
Exclusion criteria
Exclusion criteria: 1. Individuals with significant organ diseases affecting the heart, liver, lungs, kidneys, or other vital organs; blood disorders; or neoplastic conditions; 2. Subjects with major psychiatric disorders who exhibit uncontrollable behaviour and are unable to cooperate; 3. Shift workers or those with a history of long-distance travel spanning two or more time zones within the preceding three months; 4. Individuals who have consumed alcohol frequently (averaging over 60g/day) or engaged in alcohol abuse within one month prior to screening; 5. Individuals with a history of diagnosed malignant tumours or uncontrolled chronic physical conditions (e.g., hypertension, diabetes); 6. Diagnosis of any severe mental disorder within the preceding six months; 7. PHQ-9 Patient Health Questionnaire score >14 at screening [Appendix 3]; 8. GAD-7 Generalised Anxiety Disorder Scale score >9 at screening [Appendix 4]; 9. PDQ-D Cognitive Function Self-Assessment Scale score =30 at screening [Appendix 5]; 10. Concurrent severe sleep disorders other than insomnia, such as severe sleep apnoea syndrome diagnosed by PSG (AHI > 30 events/hour), severe periodic limb movement disorder (PLMI > 50 events/hour, or PLMS/arousal index > 10 events/hour), etc.; 11. At screening, total bilirubin (TBIL) exceeding 1.5 times the upper limit of normal, alanine transaminase (ALT) or aspartate transaminase (AST) exceeding 2 times the upper limit of normal, or creatinine (Cr) exceeding 1.2 times the upper limit of normal; 12. Receipt of physical therapy within three months prior to screening, including but not limited to: modified electroconvulsive therapy (MECT), repetitive transcranial magnetic stimulation (rTMS), transcranial electrical stimulation (tES), etc.; 13. Use of sedative-hypnotic drugs, antidepressants, antipsychotics, mood stabilisers, or other central nervous system-acting medications within 4 weeks prior to screening; or regular intake of supplements potentially affecting sleep patterns (e.g., melatonin); 14. Individuals with allergic constitutions or hypersensitivity to the study sample; 15. Pregnant or breastfeeding women, and those planning pregnancy within three months; 16. Recent use of substances relevant to the study function (ergothioneine, coenzyme Q10, pyrroloquinoline quinone) that may compromise outcome assessment; 17. Individuals who have participated in or plan to participate in other clinical studies within the past three months; 18. Participants who fail to consume the study sample as prescribed, rendering efficacy assessment impossible or providing insufficient data to evaluate efficacy or safety; 19. Individuals deemed unsuitable for this trial by the investigator or at high risk of loss to follow-up.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective sleep assessment;Sleep Diary Card;Pittsburgh Sleep Quality Index (PSQI) Score;Insomnia Severity Index (ISI);Sleep-Related Symptoms Scale (SRSS); | — |
Secondary
| Measure | Time frame |
|---|---|
| Vital signs; | — |
Countries
China
Contacts
Public ContactXu Dachun
Shanghai Tenth People's Hospital
Outcome results
None listed