None listed
Conditions
Interventions
Drug : For 4 weeks, the test group received a combination of oral administration of pilocarpine 5mg BID and ilaprazole 10mg BID, and the control group was treated with pilocarpine 5mg BID alone.
Sponsors
National Health Insurance Service Ilsan Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Adults between the ages of 19 and 80 (2) Patients diagnosed with Sjogren's syndrome (3) Patients with symptoms of dry mouth and pharyngeal reflux on laryngoscopy (4) A person who has listened to the explanation of this clinical study, voluntarily decided to participate and signed the consent form
Exclusion criteria
Exclusion criteria: (1) Persons with hypersensitivity to PPI drugs (2) Patients with asthma, hypersensitivity to pilocarpine, acute iritis or narrow-angle glaucoma (right-angle glaucoma) (3) Those with a history of malignant tumors of the larynx in the past (4) Those who need to continuously take non-steroidal anti-inflammatory drugs (NSAIDs) or steroids including Warfarin, Coumarin, and Aspirin (more than 325 mg/d) during the test period (5) Those who took gastric motility stimulants, antacids, steroids, or NSAIDs 7 days before the measurement of salivation (6) Those who smoke or drink alcohol or use chemical inhalants on the day of admission (7) Those who have undergone surgery or treatment for gastroesophageal reflux disease (GERD) (8) Those who have undergone gastric acid secretion suppression surgery or gastric or duodenal surgery (9) Those who have undergone major surgery that may affect gastric acid secretion, except for surgeries such as appendectomy, cholecystectomy, and hysterectomy (10) Current patients with Zollinger-Ellison Syndrome and those who are alcoholics or have a history of substance abuse (11) Pregnant women, pregnant women, and lactating women (12) Those who have participated in other clinical trials within 3 months before screening (13) Patients who were judged unsuitable for participation in the study by other researchers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in dry mouth questionnaire scores and salivary flow test score after treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in reflux symptom index and reflux finding score after treatment | — |
Countries
Korea, Republic of
Contacts
Public ContactJi-Hoon Kim
National Health Insurance Service Ilsan Hospital
Outcome results
None listed