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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xiaosong Liu, Peking University
ClinicalTrials.gov Identifier:
NCT01652625
First received: July 23, 2012
Last updated: July 25, 2012
Last verified: July 2012
  Purpose

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.


Condition Intervention Phase
Recurrent Aphthous Stomatitis
Drug: Yunnan Baiyao toothpaste
Drug: Placebo toothpaste
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • Ulcer size [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Pain Scores with Visual Analog Scale [ Time Frame: one year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: Yes ]
    Any noted adverse reactions were recorded.


Enrollment: 227
Study Start Date: March 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Yunnan Baiyao toothpaste
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.
Drug: Yunnan Baiyao toothpaste
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.
Active Comparator: placebo toothpaste
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.
Drug: Placebo toothpaste
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Xiaosong Liu, associate professor, Peking University
ClinicalTrials.gov Identifier: NCT01652625     History of Changes
Other Study ID Numbers: Peking University
Study First Received: July 23, 2012
Last Updated: July 25, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Peking University:
Yunnan Baiyao
recurrent aphthous stomatitis
clinical trial

Additional relevant MeSH terms:
Stomatitis
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 30, 2014