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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title:

Brief 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.


Detailed Summary:
Sponsor: Peking University

Current Primary Outcome: Ulcer size [ Time Frame: one year ]

The assessment of the surface area of the ulcer was measured in millimeters by a dental probe. Ulcer size was assessed as the product of maximum diameter and its vertical diameter.


Original Primary Outcome:

Current Secondary Outcome:

  • Pain Scores with Visual Analog Scale [ Time Frame: one year ]
    Pain intensity was measured using a VAS, where the amount of pain recorded ranged from 0 (no pain) to 10 (unbearable pain). Pain was assessed by irritating the ulcer with the periodontal probe. The values were collected by the assigned investigators.
  • Number of the participants with adverse events [ Time Frame: one year ]
    Any noted adverse reactions were recorded.


Original Secondary Outcome:

Information By: Peking University

Dates:
Date Received:
Date Started:
Date Completion:
Last Updated: July 25, 2012
Last Verified: July 2012