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

Brief Title

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

Official Title

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

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.
    

Study Phase

Phase 2

Study Type

Interventional

Primary Outcome

Ulcer size

Secondary Outcome

 Pain Scores with Visual Analog Scale

Condition

Recurrent Aphthous Stomatitis

Intervention

Yunnan Baiyao toothpaste

Study Arms / Comparison Groups

 Yunnan Baiyao toothpaste

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.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Drug

Estimated Enrollment

227

Start Date

March 2010

Completion Date

March 2011

Primary Completion Date

March 2011

Eligibility Criteria

        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.
      

Gender

All

Ages

18 Years - 65 Years

Accepts Healthy Volunteers

No

Contacts

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NCT ID

NCT01652625

Organization ID

Peking University

Responsible Party

Principal Investigator

Study Sponsor

Peking University

Study Sponsor

, , 

Verification Date

July 2012