Pilot evaluation of Marhame-Mafasel ointment in patients with knee osteoarthritis: a double-blind randomized trial

Evaluation of Marhame-Mafasel ointment and Diclofenac gel effect in patients with moderate knee osteoarthritis and evaluation of inflammatory factors and cytokines

Randomized Double-Blind, Controlled Clinical Trial, parallel, Phase 2-3 on 66 patients with moderate knee osteoarthritis (33 patients in each group) using computer randomization method.

This study was conducted on 66 outpatients referring to Rheumatology Clinic, Imam Khomeini Hospital Complex. Patients are classified into intervention groups after being informed about the study and obtaining informed consent. Ointments 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, Patients with moderate knee osteoarthritis ( according to Kellgren-Lawrence classification), individuals between 40-80 years Exclusion criteria: Lack of cooperation of patients, Patients with mild or severe knee osteoarthritis, Allergy to topical Nonsteroidal anti-inflammatory drugs (NSAIDs), History of steroid injection into the knee joint in the past three months, Consumption of oral NSAID drugs, Asthma, or any liver or kidney disorders

Intervention group: Marhame-Mafasel ointment, Use three times daily in the amount of 3 cm for 1 month for each knee Control group: Diclofenac gel, Use three times daily in the amount of 3 cm for 1 month for each knee

Level measurement of inflammatory factors ESR, CRP, RF, CBC, Evaluation of inflammatory cytokines TNF-α, IL-6 in serum, calculation VAS Score, Evaluation of WOMAC and WHOQOL quality of life questionnaire before and after treatment

In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and Control groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and 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.

Marhame-Mafasel ointment is a reddish-brown color with a predominant Turpentine odor. Diclofenac gel was simulated using food color and Turpentine oil In order to simulate Marhame-Mafasel ointment. The ointments were packaged in the same shape and coded by an expert one in the research center using Random Allocation Software. Researchers, patients, data collectors, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered to patients randomly using Allocation concealment.

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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