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IRCT20161204031229N7 IRCT 2022-04-14 Iran University of Medical Sciences Doxepin cream in reducing knee pain due to Arthritis Treatment of osteoarthritis of the knee with a topical doxepin: A randomised controlled trial 2022-04-14 anticipated 60 Complete https://irct.ir/trial/62601 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the simple randomization method will be used. The randomization sequence will be determined by the researchers first and then we will proceed to sampling. In this way, we will have 2 pots, in pot number 1 will be numbers from 1 to 63, and in pot number 2, 63, the number of envelopes will be opaque, in which the desired type of treatment is listed. First we will randomly select a number from the first pot and from the second pot we will randomly select an envelope and place them in a designed box. The number from pot number 1 will receive the treatment that came out of pot number 2. We will do this for every 63 issues. In fact, the type of intervention inside each envelope is unclear, which is the randomization concealment method. In fact, the treatment assigned to the numbers is not known until the person comes and the envelope is opened for him, and secondly, the names of the treatments will not be known inside the envelopes, and the names of the treatments will be A, B and C, and only the designer The study will know the type of treatment A and B, C, Blinding description: In this study, the patient and the interventionist or physician are blind and the drug group and placebo are used for blinding. After selecting the samples, the patient and the intervener or physician will have no information about randomization and the allocation process. Physicians are pre-coded (A, B, C) and patients are admitted to the study, respectively. 2-3 Knee osteoarthritis. Intervention 1: 'Control group:" The first group received placebo cream Khoramabad University of Medical Sciences، topically 3 times a day with 250-500 mg naproxen capsules for oral use. Intervention 2: "Intervention group 1:" The Second group received Doxepin 5% Khoramabad University of Medical Sciences, topically 3 times a day with 250-500 mg naproxen capsules for oral use. Intervention 3: "Intervention group 2:" The Third group received diclofenac 1% gel Nazho topically 3 times a day with 250-500 mg naproxen capsules for oral use. 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 There is no more information
public Azadeh Eshraghi
Iran University of Medical Sciences, Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 2030 eshraghi.a@iums.ac.ir Iran University of Medical Sciences scientific Azadeh Eshraghi
Iran University of Medical Sciences, Hemmat Highway, Tehran
Tehran Iran (Islamic Republic of) ۱۴۴۹۶۱۴۵۳۵ +98 21 8670 2030 eshraghi.a@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) 45_75 years old A definitive diagnosis of osteoarthritis disease with specialist 45 years 75 years Both Severe diseases such as metabolic disorders and digestive at the same time Severe infection Sensitivity to Doxepin cream Pregnancy Lactation Impaired liver function tests History of fracture or knee surgery Rheumatoid arthritis M17 Osteoarthritis of knee Placebo Treatment - Drugs Treatment - Drugs 'Control group:" The first group received placebo cream Khoramabad University of Medical Sciences، topically 3 times a day with 250-500 mg naproxen capsules for oral use "Intervention group 1:" The Second group received Doxepin 5% Khoramabad University of Medical Sciences, topically 3 times a day with 250-500 mg naproxen capsules for oral use "Intervention group 2:" The Third group received diclofenac 1% gel Nazho topically 3 times a day with 250-500 mg naproxen capsules for oral use Improving physical Function. Timepoint: Baseline and Six Weeks later. Method of measurement: Western Ontario and McMaster (WOMAC) questionnaire. Pain relief. Timepoint: Baseline and Six Weeks later. Method of measurement: Visual Analogue Scale (VAS) questionnaire. Iran University of Medical Sciences Approved 2022-03-16 Ethics committee of Iran University of Medical Sciences Hemmat Highway Tehran Tehran Iran (Islamic Republic of)