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A Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Qinshen Mouthwash in Alleviating Pain Associated with Recurrent Aphthous Ulcers

A Randomized, Double-blind, Placebo-controlled Trial on the Efficacy and Safety of Qinshen Mouthwash in Alleviating Pain Associated with Recurrent Aphthous Ulcers

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500105149
Enrollment
Unknown
Registered
2025-06-30
Start date
2025-07-01
Completion date
Unknown
Last updated
2025-07-07

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

Conditions

Recurrent Aphthous Ulcers (RAU)

Interventions

Intervention Group:Gargling with Qinshen mouthwash
Control Group:Gargling with placebo mouthwash

Sponsors

West China Hospital of Stomatology, Sichuan University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Age 18~70 years old, gender is not limited; 2. Confirmed diagnosis of recurrent aphthous ulcer with ulcer-related pain (VAS>=4) by medical history combined with intraoral examination; 3. The ulcer occurs within 48 hours, the length and diameter of the ulcer is less than or equal to 10mm, and the ulcer is greater than 3mm, and no relevant treatment has been carried out for the ulcer; 4. Voluntarily participate in the trial and sign the informed consent form, and be able to cooperate with the completion of the trial.

Exclusion criteria

Exclusion criteria: 1. Those who have a history of allergy to any of the ingredients used in this test; 2. Diagnosed with severe recurrent aphthous ulcer, or ulcer caused by trauma, cancer, drugs and other factors; or other oral mucosal diseases; 3. The location of the ulcer is not conducive to observation and measurement; 4. There are circumstances that may affect the determination of efficacy, such as pericoronitis, acute pulpitis, acute apical periodontitis; 5. Other immune diseases that may be characterized by recurrent ulcer lesions, such as ulcerative colitis, Crohn's disease, Behcet's disease, acquired immunodeficiency syndrome, etc.; 6. Those with other serious systemic diseases; 7. Those who have used drugs that may affect the efficacy evaluation within 2 weeks before the trial, including various immune preparations; 8. Those who have used painkillers or drugs that may affect the effect of pain observation within 24 hours, such as sedatives and anti-allergic drugs; 9. Those with serious systemic diseases or organ damage; 10. Pregnant or lactating; 11. Those who are unable to complete or cooperate with the test process; 12. Those who are judged by the investigator to be unsuitable for inclusion in this project.

Design outcomes

Primary

MeasureTime frame
Visual Analogue Scale for Pain;

Secondary

MeasureTime frame
Percentage Reduction in Target Ulcer Area;Time to Pain Relief in Target Ulcer;Time to Complete Healing of Target Ulcer;

Countries

China

Contacts

Public ContactXian Liu

West China Hospital of Stomatology, Sichuan University

jssyliuxian@163.com+86 138 8076 0220

Outcome results

None listed

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