Evaluation of efficacy of Erqonasa ointment in osteoarthritis of the knee joint: a randomized, double-blind, placebo-controlled trial: A Pilot Study

To evaluate the efficacy of Erqonasa topical ointment in reducing knee osteoarthritis pain compared with 1% diclofenac gel and placebo gel in a randomized clinical trial.

This study is a randomized, double-blind, parallel-group clinical trial with random allocation into three groups, conducted on 75 patients.

Eligible participants will be recruited from patients attending Hazrat Rasoul Akram Hospital after obtaining informed consent and will be randomly assigned into three groups: intervention group 1 receiving Eroqonasa topical ointment, intervention group 2 receiving 1% diclofenac gel, and the control group receiving placebo gel; all groups will receive the usual treatment. The required sample size was estimated as 60; however, considering a 20% dropout rate, 75 participants will be enrolled. The study is designed as a double-blind trial, in which both patients and the investigator are unaware of group allocation.

Participants include patients with primary knee osteoarthritis aged above 40 years, with pain severity between 4 and 10 based on VAS score , a history of pain exacerbation after discontinuation of NSAIDs or acetaminophen, and written informed consent. Patients with secondary osteoarthritis, history of joint surgery or intra-articular injection in the past six months, severe systemic diseases, uncontrolled cardiovascular disease, liver or kidney disease, fibromyalgia or other disabling conditions, and pregnant or breastfeeding women are not included in the study.

Intervention group 1 receives Erqonasa ointment every 8 hours, intervention group 2 receives 1% diclofenac gel every 8 hours, and the control group receives placebo gel every 8 hours; all three groups also receive the usual treatment.

Pain severity, Joint stiffness, Daily Function

Randomization for 75 participants is performed using Random Allocation software with a stratified randomization method. Participants are first stratified into moderate and severe pain groups, and within each stratum, random allocation to three groups is performed using a block randomization method based on the software-generated list.

This study is conducted as a double-blind trial. Participants are randomly allocated into three groups using Random Allocation software. Allocation is based on coded groups (A, B, and C), and interventions are provided in identical labeled forms without revealing their content. Participants, treating physician, and outcome assessors are blinded to group allocation. Outcomes are recorded using participant codes, and blinding is maintained until completion of data collection.

All collected deidentified IPD

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Researchers in the field of medicine and pharmacy

Development of science and expand evidence related to treatment in further research

Parastoo Mirzabeygi pmirzabeygi@gmail.com

Using the journal email to communicate and register a request to use the study data