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Efficacy and safety of mussel adhesive protein wound dressing in patients with recurrent aphthous ulcer: a randomized double-blind clinical study.

Efficacy and safety of mussel adhesive protein wound dressing in patients with recurrent aphthous ulcer: a randomized double-blind clinical study.

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-14005148
Enrollment
Unknown
Registered
2014-08-26
Start date
2014-08-28
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

recurrent aphthous ulcer

Interventions

treatment group:mussel adhesive protein wound dressing
control group:The sample carrier solution without mussel adhesive protein: the physiological saline solution containing 0.005% acetic acid

Sponsors

Department of Oral Medicine, Peking University School Of Stomatology
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects volunteered for the trial and signed the informed consent; 2. 18-65 years old and sex not limited; 3. According to the clinical symptoms and signs, subjects was diagnosed with light recurrent aphthous ulcer; 4. Ulcer occurred within 48h without treatment and generally healing time was more than five days; 5. The subjects have pain discriminating ability.

Exclusion criteria

Exclusion criteria: 1. Severe systemic infection, or systemic disease; 2. There is a history of allergies or recent allergic diseases of multiple drugs; 3. Having taken antibiotics, vitamins, sedatives or other drugs in 24h; 4. Subjects have used glucocorticoid or other drugs which affect the immune function in the last three months; 5. Female in pregnancy or suckling period; 6. Subjects with a history of diseases of the immune system; 7. Subjects have used non steroidal anti-inflammatory drugs (NSAIDS) or antihistamines in one month; 8. Tumor patients; 9. Subjects have participated in the other similar products the clinical trials in one month; 10. Researchers think that subject is not suitable for the clinical trial for other reasons.

Design outcomes

Primary

MeasureTime frame
Ulcer pain remission rate in the day 0, day 3, day 5;The area of ulce;

Secondary

MeasureTime frame
The earliest onset time of ulcer pain remission;Pain relief time;Seepage and the degree of congestion in ulce;

Countries

China

Contacts

Public ContactHua Hong
honghua1968@yahoo.com.cn+86 010-82195226

Outcome results

None listed

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