Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial

• Register: ChiCTR
• Last refreshed on: 10 August 2020
• Main ID: ChiCTR1900020803
• Date of registration: 2019-01-19
• Prospective Registration: Yes
• Primary sponsor: Chinese Academy of Medical Sciences Peking Union Medical College Hospital
• Public title: Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial
• Scientific title: Efficacy of Melatonin in patients with stable systemic lupus erythematosus complicated with insomnia: a single-center, randomized, double-blind, placebo-controlled clinical trial
• Date of first enrolment: 2019-03-01
• Target sample size: intervention group:88;control group:88;
• Recruitment status: Pending
• URL: http://www.chictr.org.cn/showproj.aspx?proj=33859
• Study type: Interventional study
• Study design: Parallel
• Phase: 4

Countries of recruitment

China

Contacts

• Name: Shuo Zhang
• Affiliation: Chinese Academy of Medical Sciences Peking Union Medical College Hospital

• Name: Mengtao Li
• Affiliation: Chinese Academy of Medical Sciences Peking Union Medical College Hospital

Key inclusion & exclusion 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: 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.

Age minimum: 18
Age maximum: 65
Gender: Both

Health Condition(s) or Problem(s) studied

systemic lupus erythematosus

Intervention(s)

intervention group:melatonin 6mg qn;control group:placebo qn;

Primary Outcome(s)

Sleep quality;

Secondary Outcome(s)

SLEDAI;SDAI;

Source(s) of Monetary Support

Basic Research Fund for the Central Public Academy of the Chinese Academy of Medical Sciences

Ethics review

Status: Approved
Approval date: 22/01/2019
Contact:

Chinese Academy of Medical Sciences Peking Union Medical College Hospital Ethics Committee