Efficacy study of additional administration of ilaprazole on patients with burning mouth syndrome caused by laryngopharyngeal reflux disease

A comparative study of efficacy of artificial saliva and artificial saliva and ilaprazole combination therapy for the treatment of Burning mouth syndrome caused by Laryngopharyngeal reflux disease

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CRIS

Registry ID

KCT0004329

Enrollment

Registered

2019-10-16

Start date

2019-11-04

Completion date

Unknown

Last updated

2019-11-05

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

Conditions

None listed

Interventions

Drug : The effect of two therapies on the burning mouth syndrome would be evaluated after administration of xerova soln alone or xerova soln and ilaprazole 10mg twice daily together for 12 weeks in pa

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients over 18 year (2) Laryngopharyngeal reflux disease patients who have RSI more than 13 and RFS more than 7 (3) Patients with suspected burning mouth syndrome caused by laryngopharyngeal reflux disease

Exclusion criteria

Exclusion criteria: (1) The highly sensitive person to proton pump inhibitor including ilaprazole (2) Those with the history of malignant tumor of the larynx (3) Those with need to take steroids or non-steroidal anti-inflammatory drugs including aspirin (more than 325mg/d), warfarin, coumarin during this clinical trial constantly (4) Those with observed a symptoms of vitamin B12 deficiency (5) Those who has undergone clonazepam therapy, hormone therapy, topical capsaicin treatment, topical lidocaine treatment, antidepressant, a-lipoic acid therapy (6) Those who has undergone surgery or treatment for gastroesophageal reflux disease (7) Those who has undergone gastric acid suppression surgery or gastro-duodenal surgery (8) Those who has undergone major surgery affecting gastric acid secretion except surgery such as appendectomy, cholecystectomy, hysterectomy (9) Psychiatric patient, alcohol addictor or those with the history of drug abuse (10) Pregnant and lactating women (11) Childbearing women (Menopausal women who are amenorrheic for at least 12 months are considered to be non-childbearing women.) (12) Those who participated in other clinical trial within 30 days before screening (13) Those who use another inhaler (14) Those with observed preneoplastic lesions or neoplastic lesions in pharynx or larynx (15) Those who are judged to be improper for this clinical trial

Design outcomes

Primary

Measure	Time frame
Visual analogue scale;Reflux symptom index (RSI)	—

Secondary

Measure	Time frame
Reflux finding score (RFS)	—

Countries

Korea, Republic of

Contacts

Public ContactJinhwan Kim

Hallym University Medical Center-Kangnam

rlawg3595@gmail.com+82-2-829-5217

Outcome results