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IRCT20201126049498N2 IRCT 2021-03-17 Shahed University The evaluation of Marhame-Mafasel oinment in the treatment of patients with knee osteoarthritis Pilot evaluation of Marhame-Mafasel ointment in patients with knee osteoarthritis: a double-blind randomized trial 2021-03-06 anticipated 66 Complete https://irct.ir/trial/54517 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, we used Random Allocation software for randomization. The random sequence of samples was performed equally as Intervention and Control groups using this software. For allocation concealment, sealed envelopes were used. In this method, each of the random sequences written on a card and is placed in the envelopes, respectively. Finally, the lid of the envelopes is glued and placed in a box, respectively. At the registration time, based on the order in which eligible participants enter the study, one of the envelopes of their choice will be opened and their assigned group will be revealed, Blinding description: Marhame-Mafasel ointment is a reddish-brown color with a predominant Turpentine odor. Diclofenac gel was simulated using food color and Turpentine oil In order to simulate Marhame-Mafasel ointment. The ointments were packaged in the same shape and coded by an expert one in the research center using Random Allocation Software. Researchers, patients, data collectors, and evaluators assess the outcome, are not aware of the contents of the package and grouping, and samples were delivered to patients randomly using Allocation concealment. 2-3 Knee osteoarthritis. Intervention 1: Intervention group: Marhame-Mafasel ointment contains Arnebia euchoma as the main plant, peppermint, and chamomile essential oil. Arnebia euchroma is a perennial herbaceous plant in the family Boraginaceae that has anti-inflammatory effects due to its alkannin and shikonin compounds. In this study, the amount of 3 centimeters of Marhame-Mafasel ointment for each knee, three times daily for 4 weeks was prescribed for the patient. Intervention 2: Control group: Diclofenac is classified in a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Topical diclofenac relieves osteoarthritis pain and stiffness and improves physical function. In this study, the amount of 3 centimeters of Diclofenac gel for each knee, three times daily for 4 weeks was prescribed for the patient. Yes - There is a plan to make this available What will be shared: All impersonal data of the participants without any name; Information on the main implications and all the information obtained from the research were published in article. When: In the relevant article after its publication To whom: Everyone who has access to the published article Conditions: After publication in the journal Where to obtain: Article and Dr Azadeh Mizani as the main researcher azadeh.mizani@yahoo.com How to obtain: An email to that person Comments:
public Azadeh Mizani
Floor 2, No. 1471, North Kargar Ave, Enghelab Sq, Traditional medicine clinical trial Research Center, Shahed University
Tehran Iran (Islamic Republic of) 1417953836 +98 21 6641 8331 azadeh.mizani@yahoo.com Shahed University scientific Abdolrahman Rostamian
Imam Khomeini Hospital Complex, Qarib Avenue, the end of Keshavarz Boulevard
Tehran Iran (Islamic Republic of) ۱۴۱۹۷۳۳۱۴۱ +98 21 6691 1294 ar.rostamian@yahoo.com Tehran University of Medical Sciences Iran (Islamic Republic of) Patient satisfaction and signing of informed consent form Patients with moderate knee osteoarthritis (individuals who classified in grade 3 or moderate included moderate joint space narrowing according to Kellgren-Lawrence classification ) individuals between 40-80 years 40 years 80 years Both Lack of cooperation of patients Patients with mild or severe knee osteoarthritis History of allergy to topical Nonsteroidal anti-inflammatory drugs (NSAIDs) Patients with a history of steroid injection into the knee joint in the past three months Consumption of oral Nonsteroidal anti-inflammatory drugs (NSAIDs) History of asthma or any liver or kidney disorders Treatment - Drugs Treatment - Drugs Intervention group: Marhame-Mafasel ointment contains Arnebia euchoma as the main plant, peppermint, and chamomile essential oil. Arnebia euchroma is a perennial herbaceous plant in the family Boraginaceae that has anti-inflammatory effects due to its alkannin and shikonin compounds. In this study, the amount of 3 centimeters of Marhame-Mafasel ointment for each knee, three times daily for 4 weeks was prescribed for the patient. Control group: Diclofenac is classified in a group of medications called nonsteroidal anti-inflammatory drugs (NSAIDs). Topical diclofenac relieves osteoarthritis pain and stiffness and improves physical function. In this study, the amount of 3 centimeters of Diclofenac gel for each knee, three times daily for 4 weeks was prescribed for the patient. Evaluation of ESR (Erythrocyte Sedimentation Rate). Timepoint: 1months after and before treatment. Method of measurement: Manual. Evaluation of CRP (C-Reactive Protein). Timepoint: 1 months after and before treatment. Method of measurement: Quantitative method with diagnostic kit. Evaluation of Rheumatoid Factor (RF). Timepoint: 1 months after and before treatment. Method of measurement: Quantitative method with diagnostic kit. Assay of TNF-α (Tumor necrosis factor α). Timepoint: 1 months after and before treatment. Method of measurement: ELISA method. Assay of Interleukin 6 (IL-6). Timepoint: 1 months after and before treatment. Method of measurement: ELISA method. Evaluation of WOMAC questionnaire or Western Ontario and McMaster Universities Osteoarthritis Index to measure and determine the severity of the disability. Timepoint: 1 months after and before treatment. Method of measurement: Questionnaire. Evaluation of visual analog scale (VAS). Timepoint: 1 months after and before treatment. Method of measurement: Questionnaire. Evaluation of World Health Organization Quality of Life-BREF (WHOQOL-BREF). Timepoint: 1 months after and before treatment. Method of measurement: Questionnaire. Shahed University Approved 2018-12-24 Shahed University Committee for Ethics in biomedical Research Opposite to Holy Shrine of Imam Khomeini, Tehran-Qom Freeway Tehran Tehran Iran (Islamic Republic of)