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Efficacy and Safety of SOWATER Antibacterial Solution Mouth Wash and SOWATER Mucosa Oral Disinfectant for the Treatment of Oral Candidiasis

Efficacy and Safety of SOWATER Antibacterial Solution Mouth Wash and SOWATER Mucosa Oral Disinfectant for the Treatment of Oral Candidiasis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087579
Enrollment
Unknown
Registered
2024-07-30
Start date
2023-08-14
Completion date
Unknown
Last updated
2024-08-05

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

Conditions

Oral Candidiasis

Interventions

SOWATER Antibacterial Solution Mouth Wash:Gargle SOWATER Antibacterial Solution Mouth Wash five times a day for one minute each time
SOWATER Mucosa Oral Disinfectant:Gargle SOWATER Mucosa Oral Disinfectant five times a day for one minute each time
Nystatin combination with SOWATER Antibacterial Solution Mouth Wash:Gargle SOWATER Antibacterial Solution Mouth Wash five times a day for one minute each time, and nystatin for one tablet three times
Nystatin combination with sodium bicarbonate mouthwash:Nystatin combination and sodium bicarbonate mouthwash Gargle sodium bicarbonate mouthwash three times a day for one minute each time, and nystati

Sponsors

Peking University School and Hospital of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

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;The quantity of salivary Candida;

Secondary

MeasureTime frame
taste assessment;

Countries

China

Contacts

Public ContactPeiru Zhou

Peking University School and Hospital of Stomatology

zhoupeiru1989@163.com+86 188 1179 6523

Outcome results

None listed

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