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IRCT20220901055848N1 IRCT 2023-02-18 Shahid Beheshti University of Medical Sciences Comparison of the effectiveness of duloxetine and nortriptyline in the treatment of pain in rheumatoid arthritis patients Comparison of the effectiveness of duloxetine and nortriptyline in the treatment of pain in rheumatoid arthritis patients 2023-02-09 anticipated 54 Complete https://irct.ir/trial/67683 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Supportive, Randomization description: The 4 random blocks are used. Each label has a letter A or B and the random sequence method is created using the website www.sealedenvelope.com using the random block method of 4 based on treatment group A or B for 54 (two groups of 27) patients. Block randomization works by randomizing participants into blocks, so that equal numbers are assigned to each treatment. For example, given a block size of 4, there are 6 possible ways to equally assign participants to a block, Blinding description: Nortriptyline and Duloxetine drugs with similar packaging, with different codes from the combination of numbers and letters A and B are used. Each patient is assigned a code at the beginning of the study, which is known by that code until the end of the study. Both the patients and the prescribing doctor are unaware of the patient grouping. 3 pain. Intervention 1: Intervention group 1: will be treated with Nortriptyline 10 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 150 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits. Intervention 2: Intervention group 2: will be treated with Duloxetine 20 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 120 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-aidentifying individuals. When: The access period starts 6 months after the results are published To whom: All researchers working in academic and scientific institutions, doctors and pharmaceutical companies will be allowed to access the information. Conditions: The applicant can access the information after providing proof of identity Where to obtain: The applicant can contact Dr. Fateme Kazemi Khaledi via e-mail: fatemekazemikhaledi@gmail.com to receive the desired documents or data. How to obtain: The applicant can communicate with the researcher through e-mail and receive the basic data after presenting the identity documents. Comments:
public Roya Vaziri Harami
Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 roya832003@yahoo.com Shahid Beheshti University of Medical Sciences scientific Roya Vaziri Harami
Shahid Madani Street
Tehran Iran (Islamic Republic of) 1617763141 +98 21 7343 0000 roya832003@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Confirmation of the clinical diagnosis of mild to moderate Rheumatoid Arthritis by a rheumatologist Presence of RF or AntiCCP in the serum of patients Patients under treatment with methotrexate, prednisolone and hydroxychloroquine Articular involvement without extra-articular involvement Age range from 18 to 70 years Pain complaint Consent to participate in the study 18 years 70 years Both The presence of major psychiatric disorders, including depression, anxiety disorders, bipolar, schizophrenia, abuse of any substance and medication. History of allergy to Duloxetine or Nortriptyline Pregnancy, breastfeeding, or planning to become pregnant in the near future Refusing to consent to receive treatment according to the instructions of this protocol Treatment - Drugs Treatment - Drugs Intervention group 1: will be treated with Nortriptyline 10 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 150 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits. Intervention group 2: will be treated with Duloxetine 20 mg of Abidi company on a daily basis; which is based on the clinical response of pain reduction (which is based on previous clinical trials a reduction of more than 30% in the baseline VAS score) for patients who did not achieve a clinical response in subsequent visits up to the maximum daily dose of 120 mg will be considered. The treatment will be done for 3 months. In order to follow up, patients will be visited 1 month, 2 months and 3 months later. And pain intensity will be measured using VAS in each of these visits. Pain level. Timepoint: Pain measurement before, 1 month, 2 months and 3 months after the start of taking one of the two drugs Nortriptyline and Duloxetine. Method of measurement: Visual Analogue Scale. Shahid Beheshti University of Medical Sciences Approved 2022-12-24 Research Ethics Committee of Shahid Beheshti University of Medical Sciences (Faculty of Medicine) Shahid Madani Street Tehran Tehran Iran (Islamic Republic of)