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Efficacy and safety of berberine hydrochloride gargle in the treatment of oral candidiasis: a randomized controlled trial

A randomized controlled study of berberine hydrochloride gargle in the treatment of oral candidiasis: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053862
Enrollment
Unknown
Registered
2021-12-01
Start date
2021-12-01
Completion date
Unknown
Last updated
2022-10-31

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

Conditions

Oral candidiasis

Interventions

Berberine hydrochloride group:0.02% berberine hydrochloride gargle
Control group:3% sodium bicarbonate mouthwash

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: 1. No gender restrictions, aged > 18 years; 2. Clinically diagnosed with erythematous oral candidiasis; 3. Positive fungal microscopic examination or positive fungal culture; 4. Female subjects of childbearing age are screened with a negative pregnancy test and voluntarily take contraceptive measures throughout the trial; 5. The subjects participated voluntarily and signed the written informed consent.

Exclusion criteria

Exclusion criteria: 1. Clinically proven to suffer from other systemic mycosis; 2. Those who are known to have a history of allergy to the test drug, cannot tolerate it, or have an allergic constitution; 3. Lactating patients; 4. Those with mental disorders who cannot cooperate well and cannot evaluate changes regularly; 5. Patients with hepatic insufficiency (ALT, AST or TBIL>1.5 times the upper limit of the normal reference value), or patients with clinical manifestations of liver disease within two months before the implementation; 6. Patients with renal insufficiency (CR>1.5 times the upper limit of the normal reference value); 7. Patients with cardiac insufficiency (such as those with ischemic heart failure or a history of congestive heart failure); 8. Those with hematopoietic system diseases; 9. Those who have received other systemic antifungal drugs within 30 days before treatment or received local antifungal drug treatment within 2 weeks; 10. Patients with chronic mucocutaneous candidiasis (CMCC); 11. HIV positive patients; 12. Patients who are clinically proven to have related diseases that affect oral saliva secretion or are taking drugs that affect saliva secretion; 13. Those who have participated in other clinical trials within the past month.

Design outcomes

Primary

MeasureTime frame
Classification of oral pain/burning sensation;Atrophic erythema classification of oral mucosa;Candida salivarius bacteria count;

Countries

China

Contacts

Public ContactZhou Peiru

Peking University School and Hospital of Stomatology

zhoupeiru1989@163.com+86 10 82195806

Outcome results

None listed

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