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

Peking University

Status and phase: Completed; Phase 2

Conditions: Recurrent Aphthous Stomatitis

Treatments: Drug: Placebo toothpaste; Drug: Yunnan Baiyao toothpaste

Study type: Interventional

Funder types: Other

Identifiers

NCT01652625

Peking University

Details and patient eligibility

About

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.

Enrollment: 227 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

1. Hypersensitive to various medical agents;
2. Concurrent acute infectious disease;
3. Pregnancy or lactation;
4. Concurrent other immunology disorders;
5. Accepting systemic administration of corticosteroids or immunosuppressive agents within 3 months;
6. Aphthous-like ulcers related to certain systemic disorders such as ulcerative colitis, Crohn's disease, Behcet's syndrome, serious anemia;
7. Aphthous-like ulcers related to drug such as non-steroidal anti-inflammatory drugs (NSAIDs) and anti-histamines;
8. 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;
9. Neoplasm patients;
10. Volunteers of other clinical trials on medical agents or toothpaste within one month.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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227 participants in 2 patient groups

Yunnan Baiyao toothpaste

Experimental group

Description:

The toothpaste containing 6.5 milligrams of Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days.

Treatment:

Drug: Yunnan Baiyao toothpaste

placebo toothpaste

Active Comparator group

Description:

One gram of 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.

Treatment:

Drug: Placebo toothpaste