Rheumatoid arthritis, unspecified
Conditions
Interventions
Test group: 26 patients, previously diagnosed with Rheumatoid Arthritis were randomized to receive melatonin (5mg) as fast-release capsules. They were instructed to take one capsule per day, two hours
Dietary supplement
SP6.051.227
Sponsors
Faculdade de Medicina da Universidade Federal do Ceará
Hospital Geral Dr. César Cals
Eligibility
Age
18 Years to 80 Years
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Brazil
Contacts
Public ContactFernando Henrique Lopes
Faculdade de Medicina da Universidade Federal do Ceará
Outcome results
None listed