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IRCT20210418051005N1 IRCT 2021-05-29 Tehran University of Medical Sciences Evaluation of the therapeutic effect of buspirone in improving the dysphagia of patients with ineffective esophageal motility. Evaluation of the therapeutic effect of buspirone in improving the dysphagia of patients with ineffective esophageal motility 2021-06-05 anticipated 50 Complete https://irct.ir/trial/55750 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 4 person blocks Patients are divided into two groups based on a table of random numbers if they go to the endoscopy department to receive medicine; Accordingly, each patient is randomly assigned a number (individual or even). Pantoprazole or a combination of pantoprazole plus buspirone is packaged in similar white bags by the research guide and will be provided to administrators for prescription. The group with odd numbers received the drug combination of pantoprazole plus buspirone, and the other group (even numbers) received the drug pantoprazole. The only person who knows the contents of the envelope is the research guide, and patients, administrators, and outcome assessors are unaware, Blinding description: Medications are given to patients by a trained nurse who is not informed about details of the study. Interpretation of the manometer is done by a specialist who is not informed about details of the study. 3 Condition 1: Ineffective esophageal motility. Condition 2: Dysphagia. Intervention 1: Intervention group: Group 1: Patients are prescribed 40 mg of pantoprazole daily for 30 days. Intervention 2: Intervention group: Group 2: Patients are prescribed 40 mg of pantoprazole daily, along with 20 mg of buspirone daily for 30 days. Yes - There is a plan to make this available What will be shared: Therapeutic effect of buspirone in improving dysphagia in patients with ineffective esophageal motility When: "Access period starts 5 months after the results are published" To whom: Academic and scientific persons Conditions: There is no limit to the use of data or documentation due to unidentifiable patient information. Where to obtain: Dr Elham Baghereslami How to obtain: After receiving an application via email, it will be answered for one week. Comments:
public Foroogh Alborzi Avanaki
Imam khomeini Hospital Complex, Keshavarz Blvd, Tehran, Iran.
Tehran Iran (Islamic Republic of) 0000000000 +98 21 6119 0000 falborzi@sina.ac.ir Tehran University of Medical Sciences scientific Foroogh Alborzi Avanaki
Imam khomeini Hospital Complex, Keshavarz Blvd, Tehran, Iran.
Tehran Iran (Islamic Republic of) 1419733141 091200000000 falborzi@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Ineffective esophageal motility Age between 18 and 70 Consent Patient with symptom 18 years 70 years Both Cancer Mechanical obstruction Eosinophilic esophagitis Diabetes Opium addiction Collagen vascular disease Muscle disorders DA21 R13.1 Motility disorders of oesophagus Dysphagia Treatment - Drugs Treatment - Drugs Intervention group: Group 1: Patients are prescribed 40 mg of pantoprazole daily for 30 days. Intervention group: Group 2: Patients are prescribed 40 mg of pantoprazole daily, along with 20 mg of buspirone daily for 30 days. Mayo Score. Timepoint: Before intervention and then after 30 days. Method of measurement: Mayo Score. Esophageal sphincter (LES) resting pressure. Timepoint: Before intervention and then after 30 days. Method of measurement: Manometer. Distal contractile integral pressure. Timepoint: Before intervention and then after 30 days. Method of measurement: Manometer. Integrated Relaxation Pressure (IRP). Timepoint: Before intervention and then after 30 days. Method of measurement: Manometer. Tehran University of Medical Sciences Approved 2020-09-02 Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (Research Ethics Committee Imam khomeini Hospital Complex, Keshavarz Blvd, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)