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IRCT20250527065942N2 IRCT 2026-01-06 Iran University of Medical Sciences herbal topical gel in osteoarthritis Formulation of herbal topical gel based on Traditional Persian Medicine and comparison of its effects with diclofenac topical gel in osteoarthritis patients 2026-01-05 anticipated 86 Complete https://irct.ir/trial/88360 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This study is designed as a randomized, double-blind, parallel-group clinical trial. Participants will be allocated into two groups, each receiving one type of intervention (herbal or diclofenac). Allocation will be performed using a simple randomization method, and blinding will be implemented through coded drug packages and by keeping the outcome assessors unaware of the assignments, Randomization description: In this study, participants will be allocated to two groups: the intervention group (herbal product) and the control group (diclofenac gel). Allocation will be performed through simple randomization (using a random number table or random number generation software). Given that both the participants and the outcome assessors (those administering questionnaires and measurements) will be blinded to the allocated product type, the study is designed as double-blind. The drug packages and gels will be identical in appearance, coded, and dispensed to the patients, Blinding description: This study will be conducted as a double-blind trial. The detailed blinding procedure for each group is as follows: 1. Participants (Patients): - Patients will be unaware of the type of treatment they receive (herbal product or diclofenac gel). - Both products will be provided in identical packaging and appearance (colorless gel, odorless, and with similar texture). - Labels on the packages will contain only a unique patient code and administration instructions, with no indication of the drug contents. 2. Healthcare Personnel (Physicians, Nurses, Physiotherapists): - Physicians and nurses who prescribe the treatment and conduct patient visits will be blinded to the treatment assigned to each patient. - All products will be prepared and dispensed by the study pharmacy unit according to the randomization codes. 3. Outcome Assessors: - Individuals responsible for assessing primary and secondary outcomes (pain, function, quality of life) will be blinded to each patient's treatment assignment. - Assessments will be performed at specified time points (baseline, 4 weeks after treatment initiation, and 2 weeks after treatment completion) by personnel independent of the treatment team. **4. Data Collectors: - Individuals responsible for collecting and entering questionnaire data will remain unaware of patient group assignments. 5. Statisticians: - Data analysts will remain blinded to group codes until the completion of the primary analysis. 6. Data Safety and Monitoring Board (DSMB): - If convened, DSMB members may access group allocation information only in essential situations (e.g., occurrence of serious adverse events). 7. Research Team (Principal Investigator and Collaborators): - All members of the research team, except the personnel responsible for randomization and drug preparation, will remain blinded to group assignments. Patient Information: All patients will be fully informed about the study objectives, procedures, potential benefits, and risks, and written informed consent will be obtained from each participant. Failure to inform patients would constitute a violation of ethical and legal principles. Unblinding: In emergency situations (e.g., severe allergic reactions or serious adverse events), unblinding will be permitted for the treating physician and the patient. All such cases will be carefully documented and included in the final analysis. 3 Primary osteoarthritis of the knee. Intervention group: Topical application of a formulated herbal gel containing extracts of Lawsonia inermis (Henna), Ricinus communis (Castor), Nigella sativa (Black seed), and Biebersteinia multifida (Bieberstein's feather). The gel will be applied three times daily (approximately every 8 hours) on the affected knee(s) for a duration of 4 weeks.. Yes - There is a plan to make this available What will be shared: Deidentified individual participant dataset including baseline characteristics, pain intensity scores (NRS/WOMAC), functional disability scores (WOMAC/Lequesne), quality of life scores (SF-36), adverse events, and treatment adherence data collected during the study. When: Data will become available 12 months after publication of the primary results (expected by December 2026) and will remain accessible for at least 10 years. To whom: Available to researchers, academic institutions, and students for non-commercial scientific research purposes upon reasonable request. Conditions: Data may be used for meta-analyses, validation studies, methodological research, or educational purposes. Requests must include a clear research proposal, ethical approval from the applicant’s institution, and a signed data use agreement. Where to obtain: Requests should be submitted via email to: aliasgharhamidi47@gmail.com; hamidia@tbzmed.ac.ir Or via postal mail to: Department of Pharmaceutical Chemistry, Faculty of Pharmacy, Tabriz University of Medical Sciences, Golgasht Street, Tabriz, East Azerbaijan, Iran. How to obtain: 1. Submission of formal request with research proposal. 2. Review by the study steering committee (within 4–6 weeks). 3. Signing of data sharing agreement. 4. Data delivery in encrypted format via secure electronic transfer. Total process time: approximately 6–10 weeks. Comments: All shared data will be fully anonymized to protect participant confidentiality. The study team reserves the right to reject requests that do not meet scientific or ethical standards.
public Ali Asghar Hamidi
Tabriz City, Golgasht Street, Tabriz University of Medical Sciences, Faculty of Pharmacy, Department of Pharmaceutical Chemistry
Tabriz Iran (Islamic Republic of) 5165990001 +98 41 3334 2178 aria@tbzmed.ac.ir Iran University of Medical Sciences scientific Ali Asghar Hamidi
Tabriz City, Golgasht Street, Tabriz University of Medical Sciences, Faculty of Pharmacy, Department of Pharmaceutical Chemistry
Tabriz Iran (Islamic Republic of) 5165990001 +98 41 3334 2178 aria@tbzmed.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Primary osteoarthritis in at least one knee, confirmed by radiological criteria on a knee radiograph (Kellgren-Lawrence grades 1, 2, and 3). Presence of pain for a minimum of two weeks prior to the initiation of therapy. Age between 40 and 80 years. Performance of routine laboratory tests (CBC with differential, FBS, LFT, BUN, Cr, ESR, CPK, serum calcium and phosphorus) and, in suspected cases, thyroid and coagulation tests (INR, PTT, PT) to rule out secondary causes. 40 years 80 years Both Secondary osteoarthritis or suspicion thereof. Active hepatic or renal disease. Peptic ulcer disease (PUD). Diabetes mellitus (uncontrolled). Thyroid or parathyroid disease/disorder. Coagulopathies or use of anticoagulant medications. A history of ischemic or hemorrhagic stroke. A history of deep vein thrombosis (DVT). Hypersensitivity to any form of anti-inflammatory drugs. Acute trauma. A history of alcohol consumption or drug abuse. Presence of dermatological diseases, infection, or wounds at the intended site of topical drug application. Use of corticosteroids by any route/for any indication. Concurrent use of any other topical medication at the intended site of drug application. Oral use of any other analgesics or compounds effective in the treatment of osteoarthritis within 10 days prior to the study initiation. Pregnancy. Chronic therapy with immunosuppressive drugs/medications. Receipt of corticosteroids within the past 3 months. Administration of non-steroidal anti-inflammatory drugs (NSAIDs) within the preceding 15 days. Bilateral knee osteoarthritis requiring treatment in both knees. Poorly-controlled diabetes mellitus. Blood dyscrasia. Allergy to hyaluronan (HA) or avian proteins (should these be used in the intervention). M17.1 Unilateral primary osteoarthritis of knee Treatment - Drugs Intervention group: Topical application of a formulated herbal gel containing extracts of Lawsonia inermis (Henna), Ricinus communis (Castor), Nigella sativa (Black seed), and Biebersteinia multifida (Bieberstein's feather). The gel will be applied three times daily (approximately every 8 hours) on the affected knee(s) for a duration of 4 weeks. Mean change in knee pain intensity score based on the Numeric Rating Scale (NRS). Timepoint: Before intervention (baseline), 4 weeks after starting the intervention, and 2 weeks after the end of intervention (week 6). Method of measurement: Knee pain intensity will be measured using a 10 cm straight ruler (Numeric Rating Scale) where 0 indicates "no pain" and 10 indicates "unbearable pain". Patients will mark their pain level on the scale. Tabriz University of Medical Sciences (Research Vice-Chancellor) Approved 2025-11-17 Ethics Committee of Tabriz University of Medical Sciences Student Research and Technology Committee Tabriz University of Medical Sciences Pardis Street, Pishghadam Street, Tabriz, Iran tabriz East Azarbaijan Iran (Islamic Republic of)