Efficacy of Melissa officinalis plus mediterranean diet in patients with moderate rheumatoid arthritis: A pilot clinical trial study protocol

Abstract

Introduction

Rheumatoid arthritis (RA) as an autoimmune disease is characterized by chronic inflammation, pain, and swelling of diarthrodial joints. Despite progress in RA diagnosis, existing medications have limited effectiveness and should be used cautiously due to their adverse and toxic effects. According to Persian medicine, Melissa officinalis is a good candidate for the treatment of inflammation diseases. This clinical trial will aim to assess the treatment efficacy of M. officinalis and serum concentration of inflammatory biomarkers (TNF-α, IL-17) and also determine the effects of the Mediterranean diet on patients with moderate rheumatoid arthritis.

Methods

This randomized, pilot double-blind placebo-controlled clinical trial study will be conducted on 20 eligible patients with moderate RA who will be randomly divided into intervention and placebo groups. The intervention group will use 500 mg of M. officinalis capsule twice a day, and the placebo group will receive 500 mg of bread powder capsule twice daily for 12 weeks. The Disease Activity Score 28-ESR, DAS 28-CRP, Clinical Disease Activity Index and Simplified Disease Activity Index, and also IL17, TNF-α will be assessed at the baseline and end of the trial as primary outcomes in both groups. As a secondary outcome, the World Health Organization Quality of Life-BREF, Depression Inventory–II questionnaire, and International Physical Activity Questionnaires will be used to assess the quality of life of patients and the antidepressant effect of M. officinalis, as well as the role of physical activity in reducing inflammation in RA patients. Kidney and liver parameters will be evaluated at pre- and post-treatment stages.

Discussion

Results of this trial are expected to confirm anti-analgesic effects of M. officinalis and its anti-inflammatory agent on serum concentration of inflammatory biomarkers (TNF-α, IL-17) in patients with moderate rheumatoid arthritis.