NCT01652625

Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 227 (actual)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Recurrent aphthous stomatitis (RAS) is a common recurrent oral disorder with no curative treatment available to date. The challenge remains in patients that do develop drug resistance and/or secondary infection, although topical corticosteroids and antimicrobials are the first therapeutic choice. The aim of the study was to evaluate the efficacy and safety of an herbal extract of Yunnan Baiyao formulated in toothpaste as an alternative therapy for minor RAS. Yunnan Baiyao is a well-known traditional Chinese medicine, formulated in a powder or capsule form. It was initially and widely used in wounds for its anti-hemorrhagic hemostatic function, and further in gastrointestinal bleeding. Yunnan Baiyao powder has been generally applied on RAS among Chinese population. In this study, a randomized, double-blind, placebo-controlled clinical trial (from March 2010 to March 2011) was conducted on a cohort of 227 minor RAS patients. The toothpaste containing Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. An assessment of ulcerative size and pain was recorded on Day 0 (baseline), Day 3 and Day 5. Any noted adverse reactions were recorded.

Conditions

• Recurrent Aphthous Stomatitis

Interventions

Type	Name	Description
DRUG	Yunnan Baiyao toothpaste	The patients were instructed to brush the teeth twice daily for 5 days, using 1 gram of Yunnan Baiyao toothpaste (equivocal to approximately 6-7 lines on a standard toothbrush) for 3 minutes. 6.5 milligrams of Yunnan Baiyao active extract were contained in 1 gram of the toothpaste.
DRUG	Placebo toothpaste	One gram of the placebo toothpaste was used twice daily by the control group patients. Except for the active Yunnan Baiyao extract, all ingredients contained in the placebo-toothpaste were the same as that in the experimental toothpaste.

Timeline

• Start date: 2010-03-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2012-07-30
• Last updated: 2012-07-30