An interventional study of pH metry and Filling out the questionnaire in Laryngopharyngeal Reflux, Laryngopharyngitis Chronic and Gastro Esophageal Reflux, sponsored by Kazakh Medical University of Continuing Education. Completed at 2 sites in Kazakhstan. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-01-10.
Sponsored by Kazakh Medical University of Continuing Education · Not applicable, Interventional, and Diagnostic
The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.
Clinical survey, medical history. 2. Objective methods for assessing the patient's condition:
4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data
The investigator will issue a Patient Information Consent for the participant in the study. 1.Patients will be asked to complete the Reflux Symptom Index questionnaire.
Clinical survey, medical history 2. Objective methods for assessing the patient's condition:
56 studies on the registry are indexed under Laryngopharyngeal Reflux; 8 are open to participants now.
This study's enrollment of 385 is above the median of 72 across 41 interventional studies indexed under Laryngopharyngeal Reflux.
Browse Laryngopharyngeal Reflux studies →Kazakh Medical University of Continuing Education is the lead sponsor of 4 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching.
Diagnostic Test: pH metry · Diagnostic Test: Filling out the questionnaire · Device: Endoscopic laryngoscopy · Device: Acoustic voice analysis
Patients with an early diagnosis of Gastroesophageal reflux disease
Diagnostic Test: pH metry · Diagnostic Test: Filling out the questionnaire · Device: Endoscopic laryngoscopy
Patients without complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching.
Diagnostic Test: pH metry · Diagnostic Test: Filling out the questionnaire · Device: Endoscopic laryngoscopy
The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.
Completion of the questionnaire index of reflux symptoms. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. Evaluation results range from 0 to 5, where 0 is an indicator of no problem, and 5 is an indicator of a serious problem
Video laryngoscopy and assessment of the presence / severity of the symptoms. Evaluation results range from 0 to 4, where 0 is an indicator of no problem, and 4 is an indicator of a serious problem
acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves
Acidity level of the main group, Week 0
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity.
Time frame: at the inclusion to the study
Acidity level of the control group 1, Week 0
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity.
Time frame: at the inclusion to the study
Acidity level of the control group 2, Week 0
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where below 6.5 indicates the acidity of the environment, above 7.5 - alkalinity.
Time frame: at the inclusion to the study
"Index of reflux symptoms" of the main group, Week 0
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at the inclusion to the study
"Index of reflux symptoms" of the control group 1, Week 0
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at the inclusion to the study
"Index of reflux symptoms" of the control group 2, Week 0
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at the inclusion to the study
Endoscopic laryngoscopy of the main group, Week 0
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at the inclusion to the study
Endoscopic laryngoscopy of the control group 1, Week 0
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at the inclusion to the study
Endoscopic laryngoscopy of the control group 2, Week 0
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at the inclusion to the study
Acoustic voice analysis of the main group, Week 0
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
Time frame: at the inclusion to the study
Acidity level of the main group, Week 4
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic.
Time frame: at 4 weeks after initial treatment
Acidity level of the control group 1, Week 4
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic.
Time frame: at 4 weeks after initial treatment
Acidity level of the control group 2, Week 4
The acidity level of the larynx is assessed using litmus paper. The range of acidity levels is from 4.5 to 9.0, where above 7.5 indicates the alkalinity of the medium, below 6.5 - acidic.
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the main group, Week 4
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the control group 1, Week 4
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the control group 2, Week 4
Patients will be asked to complete the Reflux Symptom Index questionnaire. An analysis of the results of the effectiveness of this method in patients with complaints of sore throat, coughing, burning sensation in the throat, cough, frequent sore throat, difficulty swallowing, lump in the throat, feeling of a foreign body in the throat, voice change, heartburn, belching will be carried out. The severity of the problem is calculated as the summation of all points. The problem is absent if the summation of points is 0. The problem is serious if the summation of points is 5.
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the main group, Week 4
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the control group 1, Week 4
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the control group 2, Week 4
Assessment of the state of the larynx on the scale of reflux symptoms. Where the presence and severity of the sign is assessed in points from 0 to 4. Where 0 is an indicator of no problem, and 4 is an indicator of a serious problem.
Time frame: at 4 weeks after initial treatment
Acoustic voice analysis of the main group, Week 4
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves
Time frame: at 4 weeks after initial treatment
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2021 to primary completion in Feb 2022, 13 months.
Of 14 interventional studies with no phase under Laryngopharyngeal Reflux, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 41. This study's 13 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Kazakh Medical University of Continuing Education