The comparative study of voice quality improvement according to ilaprazole administration on laryngopharyngeal reflux disease patients with voice change

The Comparative study of Voice quality improvement according to Ilaprazole administration on Laryngopharyngeal reflux disease patients with Voice change

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004179

Enrollment

140

Registered

2019-08-09

Start date

2019-09-01

Completion date

Unknown

Last updated

2019-08-26

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

Conditions

None listed

Interventions

Drug : Patients with voice disorder caused by Laryngopharyngeal reflux disease and belong to Experimental group will be orally administered Ilaprazole 10mg twice a day for 12 weeks and go through Life

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Those who don't lack decision-making capacity, with the age of between 19 and 75 (2) Those suffering from voice disorder with the score of Reflux Symptom index (RSI) and Reflux Finding score (RFS) higher than 13 and 7 point. (3) Those who agree to participate in this clinical trial voluntarily.

Exclusion criteria

Exclusion criteria: (1) Those sensitive to class of Ilaprazole (Proton pump inhibitor) (2) Those with history of malignant tumor (3) Those with need to take Warfarin, Coumarin, Aspirin(higher then 325mg/d) or steroid consistently. (4) Those with history of surgery or treatment due to Gastroesophageal reflux disease (GERD) (5) Those with history of Gastric acid suppression (6) Those with history of significant surgery which has impact on Gastric acid secretion (7) Those taking Gastric acid suppression medicine (8) Mental illiness patient, alcohol addictor or those with history of drug abuse (9) Pregnant and lactating women (10) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women.) (11) Those who participated in other clinical trial within 30 days before screening (12) Those who specialize in voice (13) Those with other observed laryngopharynx disease except laryngopharyngeal reflux disease (14) Those who are judged to be improper for this clinical trial

Design outcomes

Primary

Measure	Time frame
Voice handicap index;Multi-dimensional voice program, MDVP	—

Secondary

Measure	Time frame
Reflux Finding Score;Reflux Symptom Score	—

Countries

Korea, Republic of

Contacts

Public ContactJaegoo Cho

Koera University Guro Hospital

ki201906@gmail.com+82-2-2626-1280

Outcome results