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IRCT20201112049371N1 IRCT 2020-12-21 Ahvaz University of Medical Sciences Comparison of cefixime and the combination of cefixime and clindamycin in the treatment of patients with acute and chronic sinusitis Comparison of Cefixime and Cefixime and Clindamycin Combination with Cefixime in the Treatment of Acute and Chronic Sinusitis patients in Imam Khomeini Hospital of Ahwaz 2020-06-21 anticipated 120 Complete https://irct.ir/trial/52304 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Random function of Excel software based on patient file number will be used for randomization. Patients with acute and chronic sinusitis were included in the Excel program based on the file number. Based on the random button, patients with acute sinusitis were divided into case and control groups, and patients with chronic sinusitis were divided into case and control groups. A total of four groups of 30 people were divided between 4 groups. By entering the file number in Excel program, then the random number is selected from the data analysis command. This study has 4 groups that can be numbered from 1 to 4, respectively. We also want 30 people in each group. As a result, sequences 1 to 4 should be repeated 10 times each time.It is clear that the repetition of each number occurs once in each group, so select 1 for repeating each number and 30 for repeating the sequence. In this way, 120 units will be produced. 3 Condition 1: Acute sinusitis. Condition 2: Chronic sinusitis. Intervention 1: Intervention group: includes patients with acute sinusitis who receive cefixime tablets (Kowsar company) 400 mg daily and clindamycin capsules (Saha Daroo company) 300 mg three times a day for 21 days. Intervention 2: Control group: includes patients with acute sinusitis who receive only 400 mg daily tablets of Cefexime (Kosar Company) for 21 days. Intervention 3: Intervention group: includes patients with chronic sinusitis who receive cefixime tablets (Kosar company) 400 mg daily and clindamycin capsules (Saha Daroo company) 300 mg three times a day for 21 days. Intervention 4: Control group: includes patients with chronic sinusitis who receive only 400 mg daily tablets of Cefexime (Kosar Company) for 21 days. 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 Dr. Azam Fazlipour
Ahvaz Jundishapur University of Medical Sciences, Esfand St., Shahr-e-Daneshgahi, Golestan Blvd.,
Ahvaz Iran (Islamic Republic of) 6193673111 +98 61 3311 0000 info@ajums.ac.ir Ahvaz University of Medical Sciences scientific Dr Azam Fazlipour
Ahvaz Jundishapur University of Medical SciencesEsfand St.,Shahr-e-Daneshgahi,Golestan Blvd.,
Ahvaz Iran (Islamic Republic of) 6193673111 009861133110000 info@ajums.ac.ir Ahvaz University of Medical Sciences Iran (Islamic Republic of) Initial positive opinion by the ENT specialist on CT scan of the patient's sinuses Patient consent to enter the study no limit no limit Both Hypersensitivity to the antibiotic Cefixime Hypersensitivity to the antibiotic clindamycin Recent use of other antibiotics Patients with cystic fibrosis Immune Deficiency Patients J01 J32 Acute sinusitis Chronic sinusitis Treatment - Drugs Treatment - Drugs Treatment - Drugs Treatment - Drugs Intervention group: includes patients with acute sinusitis who receive cefixime tablets (Kowsar company) 400 mg daily and clindamycin capsules (Saha Daroo company) 300 mg three times a day for 21 days. Control group: includes patients with acute sinusitis who receive only 400 mg daily tablets of Cefexime (Kosar Company) for 21 days. Intervention group: includes patients with chronic sinusitis who receive cefixime tablets (Kosar company) 400 mg daily and clindamycin capsules (Saha Daroo company) 300 mg three times a day for 21 days. Control group: includes patients with chronic sinusitis who receive only 400 mg daily tablets of Cefexime (Kosar Company) for 21 days. Headache. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Nasal discharge. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Cough. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Nasal obstruction. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Feeling full in the face. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Discharge from the back of the throat. Timepoint: At the beginning of the study and 21 days after the study. Method of measurement: No effect (1 point), partial effect (2 points), partial effect (3 points) or full effect (4 points). Ahvaz University of Medical Sciences Approved 2018-05-19 Ethics committee of Ahvaz University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Esfand St.,Shahr-e-Daneshgahi, Golestan Blvd., Ahvaz Khouzestan Iran (Islamic Republic of)