Formulation and Evaluation of the Efficacy of Peppermint Gel in Reducing Pain and Improving Knee Joint Function in Patients with Osteoarthritis compared to diclofenac gel

Evaluating the effectiveness of a topical peppermint product in improving pain in early knee osteoarthritis compared to topical diclofenac

This study is a randomized, double-blind, controlled clinical trial with a parallel design.

Patients are enrolled in the study after an initial visit by an orthopedic specialist and a diagnosis of early osteoarthritis based on the clinical criteria of the American College of Rheumatology [1] including knee pain + osteophytes on radiographs + at least 1 of the following 3 criteria: age over 50 years, morning stiffness less than 30 minutes, and crepitus, and review of entry and exit criteria. Then, a demographic questionnaire is completed to record personal information, as well as an initial assessment to determine the level of pain based on VAS and pain, physical activity, and quality of life of patients based on the KOOS questionnaire.

Entry: 1 -Age between 50 and 80 years. 2 - Osteophyte severity grade 1 to 3 according to the Kolgren-Allernes classification 3- VAS score ≥ 4 < 8 Exclusion criteria: 1 - Attendance at another clinical study in the past 6 months 2- Cognitive or psychiatric disorder 3- Use of oral and intra-articular corticosteroids in the past two months 4- People with a history of allergy to herbal medicines

After entering the study, patients in the intervention group will be given a product containing peppermint and diclofenac gel to be applied topically around the knee three times a day for 4 weeks. Patients will be visited three times, at the beginning of treatment, after 4 weeks of treatment, and 4 weeks after stopping treatment. KOOS and VAS questionnaires will also be completed.

VAS; koos score

Randomization and Concealment of Treatment Allocation Process (Randomization and Concealment): Randomization will be performed using the permuted block randomization method. The block size is 4, and the ratio of the intervention group (peppermint gel) to the control (diclofenac gel) in each group is equal to (1:1). In each block, random sequences of four combinations (two allocations to the intervention group and two allocations to the control group) will be created in order to maintain balance in the allocation of groups. The generation of the random sequence will be performed by the project methodologist. In order to conceal the treatment process, the boxes containing the products (peppermint gel and diclofenac gel) will be labeled with random codes. After the product is allocated to each patient, the corresponding code will be recorded in the patient file. The codes will be opened after the study is completed and data collection is completed. In the event of serious adverse events, the patient's product code will be opened for review.

Blinding: Peppermint gel and diclofenac gel will be prepared in a single form, with the same label, and with the same smell and color (with the addition of color and essential oil) by a pharmaceutical specialist in the Medicinal Plants Laboratory of the Iranian Medicine Faculty of Babol. The only person who knows the nature of the drugs is the pharmacist who makes the drugs.

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