Laryngopharyngeal RefluxLPRNCT04771221
Method of Early Diagnosis of Laryngopharyngeal Reflux
A study testing pH metry, Filling out the questionnaire and Endoscopic laryngoscopy in people with Laryngopharyngeal Reflux and Laryngopharyngitis Chronic, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
Trial summary
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: examination of ENT organs. 3. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux
- What is being tested?
- pH metry, Filling out the questionnaire and Endoscopic laryngoscopy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 385 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 10 Jan 2021to 15 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patient's informed consent
- Age: 18-75 years old
- No serious somatic diseases.
- Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching.
- Diagnosis: Chronic pharyngitis
- Chronic laryngitis
Who cannot join
- Disagreement to participate in scientific research
- Age: under 18 and over 76
- Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs
- Patients with pulmonary pathologies
- Patients with allergic manifestations (seasonal hay fever, asthma, etc.)
- With diagnoses: Acute respiratory diseases
- Patients with general neuralgic disorders
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
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:
- examination of ENT organs. 3. Laboratory and instrumental research methods: Endoscopic laryngoscopy and video laryngoscopy, pH-metry, acoustic voice analysis.
4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data
Read the detailed description
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:
- examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values. Acoustic voice analysis: objective assessment of the voice condition 4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits.
- Subjective methods for assessing the condition of the larynx - Questionnaires.
- Аnalysis of the received data
- Conditions
- Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis
- Being tested
- pH metry, Filling out the questionnaire, Endoscopic laryngoscopy, Acoustic voice analysis
- Keywords
- Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis, pH monitoring, pH metric, acoustic voice analysis
- Medical subject headings
- Laryngopharyngeal Reflux, Gastroesophageal Reflux, Laryngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pH metryDiagnostic test
The collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry.
Filling out the questionnaireDiagnostic test
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
Endoscopic laryngoscopyDevice
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 voice analysisDevice
acoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves
| Study group | Role | What they receive |
|---|---|---|
| Main group | Experimental | 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. Receives: Diagnostic Test: pH metry; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy; Device: Acoustic voice analysis |
| Control group 1 | Experimental | Patients with an early diagnosis of Gastroesophageal reflux disease Receives: Diagnostic Test: pH metry; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy |
| Control group 2 | Experimental | 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. Receives: Diagnostic Test: pH metry; Diagnostic Test: Filling out the questionnaire; Device: Endoscopic laryngoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: at the inclusion to the study
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: at 4 weeks after initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2021
- Study start10 Jan 2021
- Primary completion15 Feb 2022
- Study completion15 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laryngopharyngeal RefluxStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 385 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Medical University of Continuing Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nukusbekova, Principal investigator, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04771221
- Sponsor's protocol ID
- 14-2020
- Other IDs
- 14-2020
- Acronym
- LPR
- Status last verified
- Apr 2022
- First submitted
- 23 Feb 2021
- Last updated
- 10 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Method of Early Diagnosis of Laryngopharyngeal Reflux in an Outpatient Appointment of an Otorhinolaryngologist
- ClinicalTrials.gov ID
- NCT04771221
- Acronym / sponsor ID
- LPR / 14-2020
- Conditions
- Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis
- Keywords
- Laryngopharyngeal Reflux, Laryngopharyngitis Chronic, Gastro Esophageal Reflux, Laryngitis, pH monitoring, pH metric, acoustic voice analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 385 participants (actual)
- Lead sponsor
- Kazakh Medical University of Continuing EducationUniversity, hospital or other
- Study start
- 10 Jan 2021 (actual)
- Primary completion
- 15 Feb 2022 (actual)
- Study completion
- 15 Feb 2022 (actual)
- First posted
- 25 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- examination of ENT organs. 3. Laboratory and instrumental research methods: Endoscopic laryngoscopy and video laryngoscopy, pH-metry, acoustic voice analysis.
4.Sociological method. 5. Subjective methods for assessing the condition of the larynx. 6. Аnalysis of the received data
Detailed description
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:
- examination of ENT organs: rhinoscopy, otoscopy, pharyngoscopy and laryngoscopy 3. Laboratory and instrumental research methods - Endoscopic laryngoscopy and video laryngoscopy. pH-metry: The collection of mucus from the laryngopharynx for the determination of acid-base values. Acoustic voice analysis: objective assessment of the voice condition 4.Sociological method: determination of lifestyle, nutrition, the presence or absence of bad habits.
- Subjective methods for assessing the condition of the larynx - Questionnaires.
- Аnalysis of the received data
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Main group | Experimental | Diagnostic Test: pH metry, Diagnostic Test: Filling out the questionnaire, Device: Endoscopic laryngoscopy, Device: Acoustic voice analysisPatients 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. |
| Control group 1 | Experimental | Diagnostic Test: pH metry, Diagnostic Test: Filling out the questionnaire, Device: Endoscopic laryngoscopyPatients with an early diagnosis of Gastroesophageal reflux disease |
| Control group 2 | Experimental | Diagnostic Test: pH metry, Diagnostic Test: Filling out the questionnaire, Device: Endoscopic laryngoscopyPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient's informed consent
- Age: 18-75 years old
- No serious somatic diseases.
- Patients with complaints of sore throat, coughing, burning sensation in the throat, coughing, frequent sore throat, difficulty swallowing, lump in the throat, foreign body feeling in the throat, voice changes, heartburn and belching.
- Diagnosis: Chronic pharyngitis
Key exclusion criteria (7 listed)
- Disagreement to participate in scientific research
- Age: under 18 and over 76
- Severe somatic diseases, organic lesions of the gastrointestinal tract and ENT organs
- Patients with pulmonary pathologies
- Patients with allergic manifestations (seasonal hay fever, asthma, etc.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pH metryThe collection of mucus from the laryngopharynx to determine the acid-base values through pH-metry. | Diagnostic test | Control group 1, Control group 2, Main group |
| Filling out the questionnaireCompletion 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 | Diagnostic test | Control group 1, Control group 2, Main group |
| Endoscopic laryngoscopyVideo 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 | Device | Control group 1, Control group 2, Main group |
| Acoustic voice analysisacoustic analysis of the voice was performed in singers with voice disorders before and after treatment using program of the Lingwaves | Device | Main group |
Primary outcome
Acidity level of the main group, Week 0
Time frame: at the inclusion to the study
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.
Acidity level of the control group 1, Week 0
Time frame: at the inclusion to the study
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.
Acidity level of the control group 2, Week 0
Time frame: at the inclusion to the study
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.
"Index of reflux symptoms" of the main group, Week 0
Time frame: at the inclusion to the study
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.
"Index of reflux symptoms" of the control group 1, Week 0
Time frame: at the inclusion to the study
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.
"Index of reflux symptoms" of the control group 2, Week 0
Time frame: at the inclusion to the study
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.
Endoscopic laryngoscopy of the main group, Week 0
Time frame: at the inclusion to the study
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.
Endoscopic laryngoscopy of the control group 1, Week 0
Time frame: at the inclusion to the study
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.
Endoscopic laryngoscopy of the control group 2, Week 0
Time frame: at the inclusion to the study
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.
Acoustic voice analysis of the main group, Week 0
Time frame: at the inclusion to the study
Acoustic analysis of the voice was performed in patients with a voice profession who had a voice disorder using computer program of the Lingwaves.
10 secondary outcomes
Acidity level of the main group, Week 4
Time frame: at 4 weeks after initial treatment
Acidity level of the control group 1, Week 4
Time frame: at 4 weeks after initial treatment
Acidity level of the control group 2, Week 4
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the main group, Week 4
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the control group 1, Week 4
Time frame: at 4 weeks after initial treatment
"Index of reflux symptoms" of the control group 2, Week 4
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the main group, Week 4
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the control group 1, Week 4
Time frame: at 4 weeks after initial treatment
Endoscopic laryngoscopy of the control group 2, Week 4
Time frame: at 4 weeks after initial treatment
Acoustic voice analysis of the main group, Week 4
Time frame: at 4 weeks after initial treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jan 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nukusbekova principal investigator
Doctor
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pH metry, Filling out the questionnaire and Endoscopic laryngoscopy in people with Laryngopharyngeal Reflux and Laryngopharyngitis Chronic, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acidity level of the main group, Week 0 (time frame: at the inclusion to the study). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jan 2023.