Effects of Melatonin on clinical manifestations, inflammation and sleep quality in patients with Rheumatoid Arthritis

Not Applicable

• Conditions: Rheumatoid arthritis, unspecified; M06.9

• Registration Number: RBR-8pjqh2
• Lead Sponsor: Faculdade de Medicina da Universidade Federal do Ceará

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-02-23
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruitment completed
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Have a diagnosis of rheumatoid arthritis confirmed by a rheumatologist, according to international criteria; being with the disease activity stable and not having undergone a change of therapeutic regimen in the three months prior to inclusion; not have been hospitalized for eight weeks prior to inclusion; not to abuse alcohol or illicit drugs; be over 18 years of age, have no diagnosis of cardiac, hepatic or renal insufficiency, have signed the free and informed consent form. Pregnant or breastfeeding women were not included either.

Exclusion Criteria

Patients without a conclusive diagnosis for rheumatoid arthritis; children under 18 years of age; unstable disease or in the process of therapeutic adequacy; hospital admission history in the eight weeks prior to inclusion; history of abusive use of alcohol or illicit drugs; refusal to participate in the study; pregnant or nursing women.

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Expected outcome 1: reducing inflammation in patients treated with melatonin. Measure used: dosage of Interleukin-6 (IL-6), through the enzyme-linked immunosorbent assay (ELISA), to be performed on blood samples and exhaled air condensate, collected from patients on the first and the ninth day of the treatment.;Expected outcome 2: reduction of oxidative stress in patients treated with melatonin. Measurement used: 8-isoprostane labeling, through enzyme-linked immunosorbent assay (ELISA), to be performed on blood samples and exhaled air condensate collected from patients on the first and the ninety days of treatment.

Secondary Outcome Measures

Name	Time	Method
Expected outcome 1: improvement in sleep quality in patients treated with melatonin. Measure used: application of the Pittsburgh Sleep Quality Index (PSQI) questionnaire on the first and ninth day of treatment.;Expected outcome 2: improvement in sleepiness in patients treated with melatonin. Measure used: application of the Epworth Sleepiness Scale (ESS) questionnaire on the first and ninth day of treatment.;Expected outcome 3: improvement of fatigue in patients treated with melatonin. Measure used: application of the Fatigue Severity Scale questionnaire (EGF) on the first and ninth day of treatment.;Expected outcome 4: improvement of depressive symptoms in patients treated with melatonin. Measure used: application of the Beck depression Inventory (BDI-II) questionnaire on the first and ninety days of treatment.