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

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.

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Key information

Conditions

Recurrent Aphthous Stomatitis Mouth Diseases Stomatitis Stomatitis, Aphthous Stomatognathic Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Both male and female aged 18 to 65 years old;
Patients diagnosed as minor recurrent aphthous stomatitis with the duration of each ulcer in excess of 5 days;
Fresh ulcers available with less than 72 hours eruption.

Exclusion criteria

Hypersensitive to various medical agents;
Concurrent acute infectious disease;
Pregnancy or lactation;
Concurrent other immunology disorders;
Accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months;
Aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia;
Aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (NSAIDs) and anti-histamines;
Accepting anaesthetic therapy within 24 hours, or systemic antibiotics within 2 weeks, or other management for oral ulcers within 72 hours prior to the study;
Neoplasm patients;
Volunteers of other clinical trials on medical agents or toothpaste within one month.

Treatment and study plan

Yunnan Baiyao toothpaste

Drug

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.

Placebo toothpaste

Drug

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.

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jul 30, 2012
Registry last updated: Jul 30, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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