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IRCT20211215053418N1 IRCT 2025-12-16 Babol University of Medical Sciences Formulation and Evaluation of the Efficacy of Peppermint Gel in Reducing Pain and Improving Knee Joint Function 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 2026-01-10 anticipated 72 Recruiting https://irct.ir/trial/88046 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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 description: 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. 3 Early osteoarthritis of the knee. Intervention group: After entering the study, patients will be randomly assigned to one of the drug groups (intervention with peppermint gel) or control (diclofenac gel). The intervention group will be given a product containing peppermint 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 discontinuation of treatment, and a review of drug use as well as possible side effects such as skin burning and itching and allergic symptoms will be recorded in the drug side effects checklist at follow-up times. KOOS and VAS questionnaires will also be completed.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is -
public Maedeh Rezghi
Babol. Ganj Afroz Street, Babol University of Mdical Sciences, Faculty of Traditional Medicine
Babol Iran (Islamic Republic of) ۴۷۱۷۶۴۷۷۴۵ +98 11 3219 9592 m.rezghi@mubabol.ac.ir Babol University of Medical Sciences scientific Maedeh Rezghi
No.538, Hoseyni 1 Alley, Shahid Salehi Avenue
Babol Iran (Islamic Republic of) 4717699644 +98 11 3219 8275 m.rezghi@mubabol.ac.ir Babol University of Medical Sciences Iran (Islamic Republic of) 1 - Age between 50 and 80 years. 2 - Osteophyte severity grade 1 to 3 according to the Kellgren-Allerance classification 3 - VAS score ≥4 & <8 50 years 80 years Both 1 - Participation in 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 5 - Skin disease at the joint site 6 - Patients with acute arthritis, osteoarthritis secondary to rheumatological diseases such as rheumatoid arthritis and gout, arthritisInfection, metabolic arthritis, traumatic arthritis, uncontrolled diabetes, known heart, liver, cancer 7 - Joint replacement surgery 8 - Fibromyalgia, radiculopathy and neuropathy 9 - Those who are unable to tolerate the study and complete the treatment and follow-up period 10 - Patients who are taking glucosamine, chondroitin sulfate and muscle relaxants at the same time M17 Osteoarthritis of knee Treatment - Drugs Intervention group: After entering the study, patients will be randomly assigned to one of the drug groups (intervention with peppermint gel) or control (diclofenac gel). The intervention group will be given a product containing peppermint 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 discontinuation of treatment, and a review of drug use as well as possible side effects such as skin burning and itching and allergic symptoms will be recorded in the drug side effects checklist at follow-up times. KOOS and VAS questionnaires will also be completed. The primary outcome of pain will be assessed using the VAS and KOOS questionnaires, and the secondary outcomes of joint symptoms, physical activity, exercise, and quality of life in patients will be measured using the KOOS questionnaire. Timepoint: Patients will be visited three times, at the beginning of treatment, 4 weeks after the start of treatment, and 4 weeks after stopping treatment. Method of measurement: KOOS: A valid, reliable, and responsive self-report instrument used for short-term and long-term follow-up of various knee injuries, including osteoarthritis, and was developed to expand the WOMAC index.[30] This relatively new, well-designed, and simple self-report instrument has good reliability, validity, and responsiveness in various populations with various knee problems [31].It can be used to assess the patient's opinion about knee problems in short-term and long-term follow-up periods ranging from one week to one decade, as well as in young and middle-aged people with osteoarthritis following trauma.The original version of the questionnaire has remained unchanged, although some small improvements have been made. The content of this questionnaire consists of 42 items, which are classified into 5 subgroups or arms:1. Pain intensity and frequency during physical activities [1]2. Symptoms such as knee stiffness or swelling and limited range of motion, clicking sound [2]3. Difficulty experiencing daily activities [3]4. Difficulty performing sports and recreational activities [4]5. Lifestyle changes and knee-related quality of life [5]Each question is scored between 0 and 4. The criterion for answering the questions is the patient's condition in the past week. After summing the items in each subgroup, the resulting number is obtained based on a specific formula in the form of scores between 0 and 100. Where 0 indicates a severe knee problem and 100 indicates a problem-free condition. Obtaining an overall score from the KOOS questionnaire is of no value and is not recommended [32]. Normalization of the scores of each subscale is performed using the following formulas [33].VAS: Visual analogue scale (VAS) is used to measure pain in patients.It has high validity and reliability [34, 35].The visual analogue scale for measuring pain intensity is a 10 cm ruler with the word no pain written on the left end and the word most severe pain written on the right end.The pain intensity is reported by the patient using a visual analogue scale (VAS) that has been standardized for measuring pain and recorded by the researcher. The visual analogue scale is divided from zero to ten as follows:0-1: no pain2-3: little pain4-5: a lot of pain,6-7: very bad pain8-9: maximum pain10: pain. Babol University of Medical Sciences Approved 2025-10-15 Ethics committee of Babol University of Medical Sciences Babol University of Medical sciences, Sargord Ghasemi avenue, Babol Babol Mazandaran Iran (Islamic Republic of)