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A Randomized controlled trial on the therapeutic effect of "Yuchuang powder" on flaming of heart and spleen heat pattern type recurrent oral ulcer and the effect of inflammatory factor

A Randomized controlled trial on the therapeutic effect of "Yuchuang powder" on flaming of heart and spleen heat pattern type recurrent oral ulcer and the effect of inflammatory factor

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400086094
Enrollment
Unknown
Registered
2024-06-25
Start date
2024-08-01
Completion date
Unknown
Last updated
2024-07-08

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

Conditions

Recurrent oral ulcers

Interventions

Control group:Chitosan oral gel

Sponsors

Beijing Shijitan Hospital Affiliated to Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Meets diagnostic criteria; Western medical diagnostic criteria: having a history of recurrent ROU; Ulcers mainly occur in the buccal or labial mucosa, with varying numbers and sizes; The ulcer surface is circular or elliptical, with a concave center and a pseudomembrane covering the surface. Congestion can be seen around the ulcer surface, and there is a noticeable burning or stinging sensation in the ulcer. Traditional Chinese Medicine diagnostic criteria: local burning and pain of ulcers, dry and thirsty mouth, restlessness and insomnia, anxiety and unease, dry stool and red urine, red tongue coating, yellow coating, and pulse count. (2) The patient's age is between 18 and 75 years old; (3) ROU is characterized by local symptoms and only requires local treatment; (4) The course of ROU exceeds 1 year, and the ulcer onset time before enrollment is within 48 hours.

Exclusion criteria

Exclusion criteria: (1) Severe ROU patients who require systemic treatment; (2) Oral mucosal ulcers caused by malignant tumors, Behcet's disease, acute infections, or hand, foot, and mouth disease; (3) Those who are unable to complete medication in combination with severe mental illness or cardiovascular and cerebrovascular diseases; (4) Individuals who have received treatment with other specialized drugs for ROU within 2 months of the onset of this ulcer.

Design outcomes

Primary

MeasureTime frame
Ulcer pain VAS score;

Secondary

MeasureTime frame
Ulcer duration;Duration of ulcer pain;Level of inflammatory factors in oral saliva;

Countries

China

Contacts

Public ContactYangzhi Guo

Beijing Shijitan Hospital Affiliated to Capital Medical University

guoyangzhi@outlook.com+86 183 0106 8896

Outcome results

None listed

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