Determining the effect of buspirone in the treatment of dysphagia in patients with ineffective esophageal motility.
Design
Clinical trial, without control group, with parallel groups, double-blind, randomized, phase 3 on 50 patients.
Settings and conduct
Endoscopy section
Participants/Inclusion and exclusion criteria
Inclusion criteria include willingness to participate in the study, age over 18 years and no underlying diseases, and exclusion criteria in patients include cancer, mechanical obstruction, eosinophilic esophagitis, diabetes, opium addiction, collagen vascular disease, muscle disorders and inability to follow up patients.
Intervention groups
Intervention group: Group 1: Patients are prescribed 40 mg of pantoprazole daily for 30 days. Group 2: Patients are prescribed 40 mg of pantoprazole daily, along with 20 mg of buspirone daily for 30 days.
Main outcome variables
Mayo Score
Esophageal sphincter (LES) resting pressure
Distal contractile integral pressure
Integrated Relaxation Pressure (IRP)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210418051005N1
Registration date:2021-05-29, 1400/03/08
Registration timing:prospective
Last update:2021-05-29, 1400/03/08
Update count:0
Registration date
2021-05-29, 1400/03/08
Registrant information
Name
Foroogh Alborzi Avanaki
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6119 2642
Email address
falborzi@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-05, 1400/03/15
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the therapeutic effect of buspirone in improving the dysphagia of patients with ineffective esophageal motility
Public title
Evaluation of the therapeutic effect of buspirone in improving the dysphagia of patients with ineffective esophageal motility.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ineffective esophageal motility
Age between 18 and 70
Consent
Patient with symptom
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 (investigator's opinion)
Double blinded
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.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (Research Ethics Committee