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IRCT20190125042486N1 IRCT 2019-02-22 Shahre-kord University of Medical Sciences Study the Effect of Topical Application of 1% Stachys lavandulifolia Extract Gel vs Diclofenac Gel in Knee Osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis Study the effect of topical application of 1% Stachys lavandulifolia extract gel and Declofenac gel in knee osteoarthritis on the pain and functional disability in patients with primary monoarticular knee osteoarthritis 2018-03-21 anticipated 150 Complete https://irct.ir/trial/37134 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Diagnostic, Randomization description: Simple randomization (using random numbers table and software), samples devoted to each of the three groups: A, B and C, each group consisting of 50 sample, Blinding description: All information of participants were recorded confidentially and secretly without name and with the code, and participants had not inform about the other participants other, clinical care provider also had not aware of the primary pain rate of participants. 2 primary monoarticular knee osteoarthritis. Intervention 1: Intervention group: Topical Gel Aqueous Hydrochloric Acid Extract with 200 mg of Celecoxib Capsule. Intervention 2: Control group: Topical Gel Placebo with 200 mg Celcioxide Capsules. No - There is not a plan to make this available Justification or reason for not sharing IPD is there is no any decision to share data
public Hsmidreza Asadian
Deputy for Research and Technology, Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8814646885 +98 38 3333 0061 m_asadian67@yahoo.com Shahre-kord University of Medical Sciences scientific Hamidreza Asadian
Deputy for Research and Technology,Kashani Blvd
Shahrekord Iran (Islamic Republic of) 8814646885 +98 38 3333 0061 m_asadian67@yahoo.com Shahre-kord University of Medical Sciences Iran (Islamic Republic of) A definite diagnosis of primary osteoarthritis in a knee based on the doctor's diagnostic criteria the existence of pain at least for two weeks before beginning treatment the age range between 45 years to 75 years old 45 years 75 years Both Primary osteoarthritis in both patient's knees Acute disease in liver or kidney Ulcer pepticemia Diabetes Thyroid or parathyroid disease Rheumatic arthritis coagulation disease or consumption of anticoagulant drugs History of ischemic stroke or hemorrhage History of deep vein thrombosis History of intra-articular injection during the last 6 weeks Sensitivity to each form of anti-inflammatory drugs Acute and pregnancy trauma History of alcohol use and drug abuse Skin diseases, infection or ulcers in the location of tropical use of medication Oral use of other anti-inflammatory drugs and other effective compounds in the treatment of osteoarthritis 10 days before the beginning of the study History of fracture or knee surgery M19.9 Osteoarthritis, unspecified site Diagnosis Diagnosis Intervention group: Topical Gel Aqueous Hydrochloric Acid Extract with 200 mg of Celecoxib Capsule Control group: Topical Gel Placebo with 200 mg Celcioxide Capsules Pain and functional disability. Timepoint: Six weeks. Method of measurement: Data were collected by interview, Western Ontario and McMaster Universities Arthritis Index Standard Questionnaire (WOMAC), and Vase Analog scale(VAS). Patient's function status. Timepoint: 4 times and days 0, 14,28, 42. Method of measurement: intensity of pain by Visual Analog Scale (VAS) scale and the rate of pain on the patient,s function by Western Ontario and McMaster Universities Arthritis Index(WOMAC) questionnaire were measured. No Approved 2018-03-04 Ethics committee of Shahrekord University of Medical Sciences Deputy for Research and Technology, Kashani Blvd Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)