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IRCT20260425069160N1 IRCT 2026-05-02 Personal Efficacy of Erqonasa ointment in osteoarthritis of the knee Evaluation of efficacy of Erqonasa ointment in osteoarthritis of the knee joint: a randomized, double-blind, placebo-controlled trial: A Pilot Study 2026-05-02 anticipated 75 Recruiting https://irct.ir/trial/89664 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: 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, Blinding description: 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. 2 Osteoarthritis of knee. Intervention 1: Intervention group: The intervention group will receive Erqonasa topical ointment manufactured by Kurdistan Shafa Pharmaceutical Company (Zemade Mafasel) three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Intervention 2: Second Intervention group: The second Intervention group will receive Diclofenac 1% topical gel manufactured by Sobhan Pharmaceutical Company three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Intervention 3: Control group: The control group will receive topical Placebo gel three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: After publishing the related article in international journals To whom: Researchers in the field of medicine and pharmacy Conditions: Development of science and expand evidence related to treatment in further research Where to obtain: Parastoo Mirzabeygi pmirzabeygi@gmail.com How to obtain: Using the journal email to communicate and register a request to use the study data Comments:
public Mahyar Rezvani
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
Tehran Iran (Islamic Republic of) 1475886671 1475886671 mahyar.rzv@gmail.com Iran University of Medical Sciences scientific Parastoo Mirzabeygi
School of Pharmacy, Shahid basarati St, shahid kabiri tameh (Shahin Shomali) St ,Hemmat Highway ,Tehran ,Iran
Tehran Iran (Islamic Republic of) 1475886671 +98 21 6044 8161 mirzabeygi.p@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnose of primary osteoarthritis of knee Age above 40 years Pain exacerbation after discontinuation of NSAIDs or acetaminophen (at least two times) Written informed consent Pain severity based on VAS score between 4 and 10 40 years no limit Both Secondary Osteoarthritis Joint surgery or intra-articular injection in the past six months Joint replacement Severe systemic diseases (e.g., infection) Fibromyalgia or other disabling diseases Pregnancy and breastfeeding Uncontrolled cardiovascular disease Liver or kidney disease M17.1 Unilateral primary osteoarthritis of knee Treatment - Drugs Treatment - Drugs Placebo Intervention group: The intervention group will receive Erqonasa topical ointment manufactured by Kurdistan Shafa Pharmaceutical Company (Zemade Mafasel) three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Second Intervention group: The second Intervention group will receive Diclofenac 1% topical gel manufactured by Sobhan Pharmaceutical Company three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Control group: The control group will receive topical Placebo gel three times a day for 4 weeks, along with the usual treatment. If pain is intolerable despite interventions, oral acetaminophen up to 2 g per day is permitted, and its consumption is recorded. Pain severity measured by VAS scale. Timepoint: Before intervention and four weeks after the start of intervention. Method of measurement: Pain severity measured using the VAS scale by physician assessment. Joint stiffness by WOMAC. Timepoint: Before intervention, two weeks and four weeks after the start of intervention. Method of measurement: Joint stiffness measured using the WOMAC questionnaire by physician assessment. Physical function by WOMAC. Timepoint: Before intervention, two weeks and four weeks after the start of intervention. Method of measurement: Physical function measured using the WOMAC questionnaire by physician assessment. Pain severity by WOMAC. Timepoint: Before intervention, two weeks and four weeks after the start of intervention. Method of measurement: Pain severity measured using the WOMAC questionnaire by physician assessment. Comparison of oral acetaminophen consumption across three groups. Timepoint: The fourth weeks after the start of the study. Method of measurement: Oral acetaminophen consumption (mg/day) recorded based on patient self-report in data collection forms. Personal Approved 2025-09-16 Ethics Committee of Iran University of Medical Sciences Iran University of Medical Sciences, Shahid Hemmat Highway,Tehran,Iran Tehran Tehran Iran (Islamic Republic of)