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IRCT20221224056910N1 IRCT 2023-01-03 Rasht University of Medical Sciences The effect of clarithromycin and doxycycline treatment on chronic rhinosinusitis with polyps after functional endoscopic sinus surgery The effect of clarithromycin and doxycycline treatment on sinonasal outcome in patients with chronic rhinosinusitis with polyps after functional endoscopic sinus surgery, a clinical trial study 2023-02-20 anticipated 192 Complete https://irct.ir/trial/67706 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Patients would be divided into three groups by Block Randomization and using PASS 11.0 software. The execution and production of the randomization sequence will be done by a researcher who is not involved in the clinical stages of the project, and the assistants of the project will register the participants and assign them to different groups, Blinding description: In order to avoid bias and increase validity, the double-blind method will be used in this research: the patients (through placebo) and the researcher (blind to the sample allocation and prescription drugs) have been blinded; the patients have been divided into three groups of 64 by the sealed envelope software and each patient will receive his own three-digit code. N/A Chronic Rhinosinusitis - Nasal Polyps. Intervention 1: Doxycycline + placebo group: patients receiving Doxycycline as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Doxycycline 100 mg capsules and placebo tablets along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Doxycycline include increased blood pressure, diarrhea, abdominal pain, back pain, hyperpigmentation of the skin, and inflammation and ulceration of the esophagus. Intervention 2: Clarithromycin + placebo group: patients receiving Clarithromycin as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Clarithromycin 500 tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Clarithromycin include abdominal pain, diarrhea, nausea, vomiting, dyspepsia, anorexia, headache, Dysgeusia, allergic reactions and hearing loss. Intervention 3: Placebo + placebo group: patients receiving standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with placebo tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. 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 I haven't decided yet - the release schedule is still unknown
public Dr. Ali Faghih Habibi
17th Shahrivar St. Dr. Heshmat Sq.
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3323 8308 dr.faghih@gums.ac.ir Rasht University of Medical Sciences scientific Dr. Ali Faghih Habibi
17th Shahrivar St. Dr. Heshmat Sq.
Rasht Iran (Islamic Republic of) 4139637459 +98 13 3323 8308 dr.faghih@gums.ac.ir Rasht University of Medical Sciences Iran (Islamic Republic of) Consent to participate in the study Age 18 - 65 years Disease diagnosis based on clinical symptoms and computerized tomography scan (CT scan) by an Otorhinolaryngology surgeon Presence of sinus polyps with no clinical response to antibiotic treatments Patients with a Lund Mackay score of 20 or above Normal coagulation tests including prothrombin time (PT) , partial thromboplastin time (PTT), international normalized ratio (INR) History of endoscopic nasal surgery before the study 18 years 65 years Both History of systemic diseases involving the nose and sinuses such as Wegener's disease, sarcoidosis, cicatricial pemphigoid, acquired immunodeficiency syndrome (AIDS) , T-cell lymphoma, primary ciliary dyskinesia, cystic fibrosis, tumors of the nose and sinuses Fungal sinusitis History of allergy to macrolides or tetracyclines Pregnancy and breastfeeding in women History of coagulation disease (such as hemophilia) or the use of anticoagulants such as heparin Severe systemic diseases such as uncontrolled diabetes or severe congestive heart failure Mucocele Surgery complications Taking medications with drug interactions with the antibiotics using in this study J32-J33 Chronic Sinusitis – Nasal polyp Treatment - Drugs Treatment - Drugs Placebo Doxycycline + placebo group: patients receiving Doxycycline as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Doxycycline 100 mg capsules and placebo tablets along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Doxycycline include increased blood pressure, diarrhea, abdominal pain, back pain, hyperpigmentation of the skin, and inflammation and ulceration of the esophagus. Clarithromycin + placebo group: patients receiving Clarithromycin as add-on therapy to standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with Clarithromycin 500 tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Also, patients will be checked for drug side effects after starting the treatment. The evaluated side effects of Clarithromycin include abdominal pain, diarrhea, nausea, vomiting, dyspepsia, anorexia, headache, Dysgeusia, allergic reactions and hearing loss. Placebo + placebo group: patients receiving standard chronic rhinosinusitis (CRS) treatment : After endoscopic functional sinus surgery, 64 patients assigned to this group were treated for at least three weeks with placebo tablets and placebo capsules along with the standard chronic rhinosinusitis regimen (nasal irrigation with physiological serum, fluticasone steroid spray two puffs in the morning and night). The failure or success of treatment will be evaluated through clear reduction of signs and symptoms, improvement of quality of life and prevention of progression or recurrence of the disease based on endoscopic findings and by continuous follow-up. All patients refer to Amir al-Momenin Hospital on an outpatient basis at the same and specified time intervals for clinical re-evaluation and sinus endoscopy. In these consultations, which take place one month, three months and six months after surgery, all patients are evaluated with SNOT22 and Lund Kennedy questionnaires, and the patients' information is recorded. In other words, the follow-up period of patients will be 6 months. Recurrence of disease. Timepoint: First, third, and sixth months follow up. Method of measurement: Based on physical examination and endoscopic findings. Sinonasal outcome. Timepoint: First, third, and sixth months follow up. Method of measurement: Based on sino-nasal outcome test 22 score (SNOT-22 score). Endoscopic condition. Timepoint: First, third,and sixth months follow up. Method of measurement: Lund-Kennedy scale. Drugs adverse effects. Timepoint: First, third, sixth months follow up. Method of measurement: Clinical history and physical examination. Rasht University of Medical Sciences Approved 2022-08-31 Research Ethic Committees of Guilan University of Medical science Guilan university of medical science Rasht Guilan Iran (Islamic Republic of)