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Efficacy of Voice Therapy Combined with Proton Pump Inhibitors in Patients with Single Positive Laryngopharyngeal Reflux Scores: A Randomized Controlled Trial

Efficacy of Voice Therapy Combined with Proton Pump Inhibitors in Patients with Single Positive Laryngopharyngeal Reflux Scores: A Randomized Controlled Trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101291
Enrollment
Unknown
Registered
2025-04-23
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laryngopharyngeal reflux (LPR), Voice disorder

Interventions

Voice Therapy Only Group:Voice Therapy
Combined Treatment Group:Proton Pump Inhibitor Combined with Voice Therapy

Sponsors

The First Affiliated Hospital,Sun Yat-sen University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 60 Years

Inclusion criteria

Inclusion criteria: 1.Age 18 to 60 years, no gender restriction. 2.Single positive RFS or RSI score (RFS > 7 and RSI = 13, or RFS = 7 and RSI > 13). 3.Complaints of voice disorders with symptoms persisting for at least 4 weeks, including hoarseness, difficulty in phonation, or changes in voice quality. 4.Willing to comply with treatment and follow-up, and able to complete questionnaire assessments and voice analysis as required. 5.Signed informed consent.

Exclusion criteria

Exclusion criteria: 1.Presence of other diseases that may cause voice disorders, such as vocal cord paralysis, laryngeal cancer, or laryngeal papilloma. 2.Acute respiratory infection or acute laryngitis within the past 4 weeks. 3.Diagnosed allergic diseases (e.g., allergic rhinitis, chronic sinusitis). 4.Treatment with PPI or other acid-suppressing medications within the past 6 months, or a known history of allergy to PPI. 5.Smoking or alcohol consumption more than 3 days per week. 6.Pregnant or lactating women. 7.Patients with mental disorders or those unable to cooperate with the study. 8.Inability to complete follow-up or a clear statement of intention to withdraw from the study. 9.Other diseases or special conditions that, in the investigator’s judgment, may affect the study results.

Design outcomes

Primary

MeasureTime frame
Effective Rate of Voice Disorder Improvement;Reflux Symptom Index (RSI);

Secondary

MeasureTime frame
voice analysis(Jitter?Shimmer and MPT);Grade, Roughness, Breathiness, Asthenia, Strain Scale (GRBAS);

Countries

China

Contacts

Public ContactDengjie

The First Affiliated Hospital,Sun Yat-sen University

dengjie6@mail.sysu.edu.cn+86 13660218195

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026