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IRCT20220413054528N1 IRCT 2022-06-22 Shahid Beheshti University of Medical Sciences Effect of diltiazem and fluoxetine on DES Comparison of distal esophageal spasm treatment with Diltiazem vs. Fluoxetine on clinical and monomeric findings 2022-06-22 anticipated 80 Complete https://irct.ir/trial/62969 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Based on sample size of study, 20 blocks with a size of 4 (such as AABB, ABAB, etc.) in a randomly varied order, will be used for random allocation. Random blocks will be provided by GraphPad software. The blocks will be placed one after the other in sequence, from the first to the 20th of them (equivalent to the first to the 80th patient). For example, if the blocks that will be provided by the software are AABB, BBAA, ABAB, respectively, the order of patients’ bowel preparation regimens will be AABBABABBBAA. The order of the blocks (20 provided blocks, it means arranging 80 drug regimens for 80 patients) will be reposed to the clinic secretary. Patients who will be diagnosed distal esophageal spasm based on manometry, and declare their informed consent to enter the study, will receive a drug regimen based on the provided blocks A or B, respectively, Blinding description: Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug. 3 Distal esophageal spasm. Intervention 1: The first group will be treated with fluoxetine 10 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug. Intervention 2: The second group will be treated with diltiazem 30 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Ahmad Ghorbanpour Rasekh
Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti University of Medical Scienc
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 9982 a_g_rassekh@yahoo.com Shahid Beheshti University of Medical Sciences scientific Ahmad Ghorbanpour Rasekh
Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran.
Tehran Iran (Islamic Republic of) 1985711151 +98 21 2243 9982 a_g_rassekh@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Age more than 18 years All patients diagnosed as distal esophageal manometry according to manometry 18 years no limit Both 1. Patients abusing drugs 2. Patients with systemic disorders including :Mastocytosis Systemic vasculitis, Sarcoidosis, Hypothyroidism, Diabetes mellitus, Fibromyalgia, Adrenal insufficiency, Coeliac disease, inflammatory bowel disease, Hypertension (high blood pressure), Metabolic syndrome, AIDS, Graves' disease, Systemic lupus erythematosus, Rheumatoid arthritis, Atherosclerosis, Sickle cell disease, Myasthenia gravis, Systemic Sclerosis, Sinusitis K22.4 Dyskinesia of esophagus Treatment - Drugs Treatment - Drugs The first group will be treated with fluoxetine 10 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug. The second group will be treated with diltiazem 30 mg daily and omeprazole 20 mg every 12 hours for 2 months. Completion of questionnaires and esophageal manometry will be done before and 2 months after the start of medication. Due to the apparent similarity of the drugs, the patient does not know the type of drug. The person who responsible for collection of patients' data and questionaries also does not know the type of drug. Improvement of clinical manifestations (chest pain, dysphagia). Timepoint: Before intervention and 2 months after intervention. Method of measurement: Questionnaire of patients symptoms, Questionnaire of quality of life, Eckardt score, Psychological questionnaire HADS and SF-36, esophageal manometry. Improvement of esophageal manometric parameters. Timepoint: Before intervention and 2 months after intervention. Method of measurement: Esophageal manometry. Shahid Beheshti University of Medical Sciences Approved 2021-07-19 Ethics committee of Gastroenterology and Liver Diseases Research Institute, Shahid Beheshti Universi Gastroenterology and Liver Diseases Research Institute, No 1, Ayatollah Taleghani Hospital, Shahid Arabi Ave., Yaman St., Shahid Chamran Highway, Tehran. Tehran Tehran Iran (Islamic Republic of)