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IRCT20230314057713N2 IRCT 2025-10-23 Babol University of Medical Sciences Investigating the effect of cinnamon on knee osteoarthritis Investigating the effect of cinnamon extract on reducing pain and improving function in patients with knee osteoarthritis compared to diclofenac gel. 2025-11-22 anticipated 72 Complete https://irct.ir/trial/86947 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be performed using the randomized permutation block method. The block size is considered to be 4 and the ratio of drug to control in each group is equal to (1:1).The generation of random sequences will be performed by the methodologist. To conceal the treatment process, random codes are written on the boxes, Blinding description: The cinnamon and diclofenac gel product will be prepared in a single form, with the same label and similar odor and color by adding color and essential oil by a pharmaceutical specialist in the Medicinal Plants Laboratory of the Faculty of Iranian Medicine, Babol. To ensure proper blinding and equalization of sensory conditions of the two groups (cinnamon gel and diclofenac gel), a very small percentage of cinnamon essential oil will be used in the can containing diclofenac gel. This procedure is done to maintain the integrity of the blinding and prevent participants or assessors from identifying the intervention group. The only person who knows the nature of the drugs is the pharmacist who manufactured the drug. 3 Knee osteoarthritis. Intervention 1: Intervention group: Topical gel containing cinnamon bark essential oil. First, the pure essential oil of this plant is procured from Giah Kala Company. Subsequently, the gel base is prepared using Carbomer 940 and distilled water: Carbomer 940 is gradually added to distilled water under continuous magnetic stirring until a preliminary gel structure forms. Next, cinnamon bark essential oil is slowly incorporated into the gel base and thoroughly mixed to ensure uniform dispersion throughout the gel. To enhance the solubility of the essential oil and improve skin permeability, varying concentrations of propylene glycol are added as a co-solvent and absorption enhancer, and completely blended into the formulation. Methylparaben and propylparaben are included as preservatives to prevent microbial growth and enhance formulation stability. In the final step, triethanolamine is added dropwise to the mixture to neutralize the acidic groups of Carbomer, thereby yielding a gel with appropriate viscosity and pH. The final formulation is standardized based on the concentration of its active constituent, cinnamaldehyde. Quantification of cinnamaldehyde is performed using High-Performance Liquid Chromatography (HPLC), a method known for its high accuracy and precision in measuring this compound. Additionally, total phenolic content is determined using the Folin–Ciocalteu reagent. Furthermore, to ensure product safety, microbiological quality control tests—including total microbial count, absence of pathogenic microorganisms (such as *Pseudomonas aeruginosa*, *Escherichia coli*, and *Staphylococcus aureus*), and assessment for fungi and yeasts—are conducted in accordance with pharmacopoeial guidelines. One knuckle of the topical product every eight hours. Intervention 2: Control group: Control group: 60 grams of 1% diclofenac gel from Sobhan Pharmaceutical Company, one knuckle of the topical product every eight hours. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Mozafar Ekhlasi
Modares Blvd. Shahid Motahari St. Tarbiat St.
Bourojen Iran (Islamic Republic of) 8871833988 +98 38 3422 4372 mozafareghlasi@gmail.com Babol University of Medical Sciences scientific Seyed Ali Mozaffarpour
Babol University of Medical Sciences, Faculty of Traditional Iranian Medicine, Ganj Afroz Street
Babol Iran (Islamic Republic of) 4717647745 +98 11 3219 4730 Seyyedali1357@gmail.com Babol University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Age between 50 and 80 years Osteophyte severity grade 1 to 3 according to the Kellgren-Allrens classification Visual Analog Scale (VAS) score less than or equal to 4 to 8 in X.ray 50 years 80 years Both Participation in another clinical study in the past 6 months Cognitive or mental disorder Use of oral and intra-articular corticosteroids in the past two months People with a history of allergies to herbal medicines Skin disease at the joint site Patients with acute arthritis, osteoarthritis secondary to rheumatological diseases such as rheumatoid arthritis and gout, infectious arthritis, metabolic arthritis, traumatic arthritis, uncontrolled diabetes, known heart, liver, cancer cases Surgical joint replacement Fibromyalgia, radiculopathy, and neuropathy Those who are unable to tolerate the study and complete the treatment and follow-up period Patients who take glucosamine, chondroitin sulfate, and muscle relaxants at the same time M17.9 Osteoarthritis of knee, unspecified Treatment - Drugs Treatment - Drugs Intervention group: Topical gel containing cinnamon bark essential oil. First, the pure essential oil of this plant is procured from Giah Kala Company. Subsequently, the gel base is prepared using Carbomer 940 and distilled water: Carbomer 940 is gradually added to distilled water under continuous magnetic stirring until a preliminary gel structure forms. Next, cinnamon bark essential oil is slowly incorporated into the gel base and thoroughly mixed to ensure uniform dispersion throughout the gel. To enhance the solubility of the essential oil and improve skin permeability, varying concentrations of propylene glycol are added as a co-solvent and absorption enhancer, and completely blended into the formulation. Methylparaben and propylparaben are included as preservatives to prevent microbial growth and enhance formulation stability. In the final step, triethanolamine is added dropwise to the mixture to neutralize the acidic groups of Carbomer, thereby yielding a gel with appropriate viscosity and pH. The final formulation is standardized based on the concentration of its active constituent, cinnamaldehyde. Quantification of cinnamaldehyde is performed using High-Performance Liquid Chromatography (HPLC), a method known for its high accuracy and precision in measuring this compound. Additionally, total phenolic content is determined using the Folin–Ciocalteu reagent. Furthermore, to ensure product safety, microbiological quality control tests—including total microbial count, absence of pathogenic microorganisms (such as *Pseudomonas aeruginosa*, *Escherichia coli*, and *Staphylococcus aureus*), and assessment for fungi and yeasts—are conducted in accordance with pharmacopoeial guidelines. One knuckle of the topical product every eight hours. Control group: Control group: 60 grams of 1% diclofenac gel from Sobhan Pharmaceutical Company, one knuckle of the topical product every eight hours. Pain score on the VAS questionnaire. Timepoint: Five self-assessment sessions: before the start of the intervention and on days 7, 14, 21, and 28 after the intervention. Method of measurement: VAS questionnaire. Pain score and symptom improvement, physical activity, and quality of life in patients with osteoarthritis from the Knee injury and Osteoarthritis Outcome Score (KOOS) tool. Timepoint: Three evaluations by a doctor: at the beginning of treatment, after 4 weeks of starting treatment, and 4 weeks after stopping treatment. Method of measurement: KOOS tool. Pain score from VAS tool. Timepoint: Three evaluations by a doctor: at the beginning of treatment, after 4 weeks of starting treatment, and 4 weeks after stopping treatment. Method of measurement: VAS tool. Babol University of Medical Sciences Approved 2025-10-13 Research Ethics Committees of Babol University of Medical Sciences Deputy of research and technology, University of Medical Sciences, Ganjafrooz Street, Babol Babol Mazandaran Iran (Islamic Republic of)