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A randomized controlled double-blind double-dummy clinical study on the efficacy and safety of herbal mouthwash for recurrent oral ulcers

A randomized controlled double-blind double-dummy clinical study on the efficacy and safety of herbal mouthwash for recurrent oral ulcers

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000738
Enrollment
Unknown
Registered
2025-04-14
Start date
2025-04-16
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

recurrent oral ulcers

Interventions

experimental group:Herbal gargle+Placebo granule
control group:Placebo gargle compound+pearl aphthous ulcer granules

Sponsors

The First Affiliated Hospital of Zhejiang Chinese Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1. Voluntarily sign informed consent before trial-related activities, be able to understand the procedure and method of the trial, and be willing to strictly follow the clinical trial protocol to complete the trial. 2. Age 18-75 years old, male or female. 3. It meets the classification and diagnosis criteria of recurrent oral ulcer, and the TCM syndrome type is aphthus-dampness-intrinsic syndrome. 4. No cancer or mental illness. 5. Antibiotics, painkillers, healing drugs, and other related therapeutic drugs have not been used in the past week, or the last medication has exceeded 7 half-lives subject to the elderly.

Exclusion criteria

Exclusion criteria: 1) Diagnosed as hand-foot-mouth disease, herpetic stomatitis, oral candidiasis, and other infectious diseases with similar clinical manifestations. 2) Oral ulcers caused by allergies and chemotherapy drugs. 3) Combined with other active oral periodontal and gingival diseases. 4) Patients with severe renal failure (creatinine exceeding 3 times the upper limit of normal) and liver function impairment (transaminase exceeding 5 times the upper limit of normal). 5) Fasting blood glucose =11.1mmol/L. 6) Allergic to various drugs in the program. 7) Pregnant and lactating women. 8) Researchers believe that poor adherence affects the evaluation of drug safety and efficacy as well as drug abusers.

Design outcomes

Primary

MeasureTime frame
clinical efficacy;

Secondary

MeasureTime frame
Canker ulcer pain index(painP);Mean ulcer healing time(timeT);the prolonged recurrence interval of ulcers(Recurrence timeRt);Ulcer lesion index(acreageA);

Countries

China

Contacts

Public ContactLiping XU

The First Affiliated Hospital of Zhejiang Chinese Medical University

yuqian920920@126.com13819116384

Outcome results

None listed

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