Pilot evaluation of the anti-inflamation and analgesics effect of oral administration of Melissa officinalis in patients with Rheumatoid arthritis: a double-blind randomized crossover trial

Evaluation of the anti-inflammation and analgesics effect of Melissa officinalis in patients with moderate Rheumatoid arthritis and evaluation of inflammatory factors and cytokines

Randomized Double-Blind, Placebo-Controlled Clinical Trial, parallel, Drug and Placebo, Phase 2 on 20 patients with moderate rheumatoid arthritis using computere randomization method.

This study was conducted on 20 خutpatients referring to Rheumatology Clinic, Imam Khomeini Hospital Complex. Patients are classified into intervention groups after being informed about the study and obtaining informed consent. Medicines have no name and only numbers and are given to the patient. Tests and examinations are performed and compared before and after the intervention. Researchers, rheumatologists, and patients are unaware of the allocation of study groups.

Inclusion criteria: Patient satisfaction and signing of the informed consent form, Confirmation of patients with moderate Rheumatoid Arthritis Using the Criteria of the American College of Rheumatology, Patients over 18 years, During the period of the disease up to 15 years, DAS Score between 3-5 Exclusion Criteria: Lack of cooperation of patientsو History of Heart, kidney, liver and ... diseasesو Pregnancyو Any kind of Immunodeficiency diseasesو No other autoimmune diseases

Drug Group: Capsule containing Melissa officinalis dry leaf, 500 mg Placebo: Capsule containing Bread powder, 500 mg

Level measurement of inflammatory factors ESR, CRP, RF, CBC, Evaluation of inflammatory cytokines TNF-α, IL-17 in serum, calculation of DAS28 and VAS Score in rheumatoid arthritis patients to assess pain and inflammation level, Evaluation of WHOQOL quality of life questionnaires and Beck Depression 2 before and after treatment, and Anti ccp test before treatment

In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and Placbo groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and they is placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed.

Bottles of drugs and placebo were coded by an expert one in the research center. Researchers, patients, data collectors, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered as random double-blind to the patient. Patients received the number to their referral and entered the study. The number of patients was randomly selected by computer and divided into two groups.

All impersonal data of the participants without any name; Information on the main implications and all the information obtained from the research were published in article.

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Article and Dr Azadeh Mizani as the main researcher azadeh.mizani@yahoo.com

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