Oral Candidiasis
Conditions
Interventions
miconazole nitrate group:miconazole nitrate sustained release oral paste for topical use once a day
Itroconazole group:Itroconazole capsule 100mg QD P.O.
Sponsors
Peking University School and Hospital of Stomatology
Eligibility
Sex/Gender
All
Age
19 Years to 70 Years
Inclusion criteria
Inclusion criteria: The inclusion criteria were: 1. age range of 18-70 years; 2. diagnosis of oral candidiasis was established based on clinical manifestation and laboratory testing (smear test and fungi culture); 3. patients with positive smear test are eligible for instant enrollment; 4. positive rate of fungi culture>80%; 5. negative reaction to pregnancy test in women and willing to take effective method of birth control in the period of trial; 6. voluntarily participating and Informed Consent Form being signed.
Exclusion criteria
Exclusion criteria: 1. diagnosis of cryptococcosis or other systemic fungal infections; 2. a history of a known allergy or intolerance to miconazole nitrate and/or itroconazole; 3. use of rifampicin, rifabutin, isoniazid, phenobarbital, phenytoin, methylprednisolone, carbamazepine, terfenadine, astemizole or cisapride; 4. history of pregnancy or breast-feeding; 5. history of psychological disorder that enable to cooperate; 6. hepaticinsufficiency with serum aminotransferase and total bilirubin levels at 1.5 times the upper limit of normal, or active clinical signs 2 months prior to the trial; 7. serum creatinine levels at 1.5 times the upper limit of normal; 8. history of cardiac insufficiency such as ischemic heart failure; 9. history of hematological diseases; 10. use of systemic or topical antifungal therapy within 2 weeks before study entry (patients received topical treatment with miconazole nitrate or nystatin cream or suppositor remain eligible for enrollment in the study); 11. diagnosis of chronic mucocutaneous candidiasis; 12. hyposalivation related disease or drug-taking; 13. HIV positive; 14. history of participating other clinical trials within 4 weeks before study entry.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical symptoms rating (Pain and burning sensation level) Pain and burning sensation;Clinical sign rating(pseudomenbran and erythema);candida elimination rate;ECG;CBC;Biochemical Examination; | — |
Countries
China
Contacts
Public ContactHong Hua
Peking University School and Hospital of Stomatology
Outcome results
None listed