The effects of melatonin supplementation in the treatment of rheumatoid arthritis

Study of the effects of melatonin supplementation on clinical status and metabolic profiles in patients with rheumatoid arthritis

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20170513033941N67

Enrollment

Registered

2019-11-30

Start date

2019-10-23

Completion date

Unknown

Last updated

2020-11-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid arthritis. Rheumatoid arthritis with rheumatoid factor

Interventions

Intervention 1: Intervention group: 6 mg/day Melatonin (RAZAK, Iran), one hour before bedtime for 12 weeks. Intervention 2: Control group: Placebo (Barij Essence, Iran), one hour before bedtime for 12

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: Patients diagnosed with rheumatoid arthritis Individuals aged 20-80 years old

Exclusion criteria

Exclusion criteria: Patients with infectious, malignant and other inflammatory diseases those taking melatonin supplements or antioxidant supplements within 3 months prior to enrollment in the study the night shift workers subjects taking antibiotics medications unwillingness to cooperate Patients with thyroid diseases Current smokers Rheumatoid arthritis patients who were diagnosed less than on 1 year before the start of the study

Design outcomes

Primary

Measure	Time frame
CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Qualitative (Negative, +1, +2 and +3).;ESR. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: mm/h.;Disease activity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: DAS28-ESR (using a questionnaire for VAS and a checklist to note physical examination results).	—

Measure

Time frame

CRP. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Qualitative (Negative, +1, +2 and +3).;ESR. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: mm/h.;Disease activity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: DAS28-ESR (using a questionnaire for VAS and a checklist to note physical examination results).

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Secondary

Measure	Time frame
Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione peroxidase. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.	—

Measure

Time frame

Malondialdehyde. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Glutathione peroxidase. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Total antioxidant capacity. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Spectrophotometry.;Triglycerides. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Total cholesterol. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;HDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;Insulin. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Elisa kit.;Fasting plasma glucose. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.;LDL. Timepoint: At the beginning of the study and after 12 weeks of intervention. Method of measurement: Enzymatic kit.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAmirhossein Loghman

Kashan University of Medical Sciences

amirhosseinloghman@gmail.com+98 31 5554 0021

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026