Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis
Status:
Completed
Trial end date:
2011-03-01
Target enrollment:
Participant gender:
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.