systemic lupus erythematosus
Conditions
Interventions
intervention group:melatonin 6mg qn
control group:placebo qn
Sponsors
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosed with SLE according to 1997 or 2012 American College of Rheumatology SLE classification criteria; 2. The disease activity is stable, that is, the SLE disease activity score (SLEDAI) = 4 points; 3. Therapeutic stability: glucocorticoid dose stability > 4 weeks, immunosuppressive dose and type stable > 12 weeks, no application of cyclophosphamide; 4. Comply with ICD-10 diagnostic criteria for insomnia: difficulty in falling asleep, difficulty in sleeping or early awakening; sleep disorder at least three times a week for at least one month; day and night focus on insomnia, excessive worry about the consequences of insomnia; sleep quality/quantity; dissatisfaction caused obvious distress or affected social and professional functions; the duration was one month; 5. Adults aged 18 and 65 years; 6. To have independent behavior, a certain ability to understand and cooperate with the completion of the study; 7. The patient is able to understand the research protocol and is willing to participate in the study, signing a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Patient is likely to receive intensive treatment (such as steroid pulse therapy, immunoglobulin, etc.); 2. The application of glucocorticoids is greater than prednisone 15 mg / day or an equivalent dosage of other forms of corticosteroids; 3. The patient continues to maintain stability for >5 years, that is, maintain SLEDAI = 4 points state for more than 5 years; 4. Patients with other types sleep disorders defined by ICD-10, that is, respiratory related sleep disorders, unspecified sleep disorders, and significant psychosis or neurological disorders (anxiety, depression, dementia); 5. The presence of melatonin contraindications, such as allergies to melatonin active ingredients or excipients; 6. Apply or use any drug that affects the central nervous system or sleep within 2 weeks prior to enrollment, such as antipsychotics, antiepileptics, barbiturates, antidepressants or anxiolytics; 7. Pregnant or lactating women; 8. Patients or their families cannot understand the conditions and objectives of this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sleep quality; | — |
Secondary
| Measure | Time frame |
|---|---|
| SLEDAI;SDAI; | — |
Countries
China
Contacts
Public ContactMengtao Li
Chinese Academy of Medical Sciences Peking Union Medical College Hospital
Outcome results
None listed