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

NCT01652625 | Completed Phase 2 DMC

• 1 other identifier: Peking University
• Study Type: interventional
• Target: 227
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Recurrent Aphthous Stomatitis

Keywords

Yunnan Baiyao; recurrent aphthous stomatitis; clinical trial

Outcome Measures

Primary Outcomes (1)

• Ulcer size

  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.

  one year

Secondary Outcomes (2)

• Pain Scores with Visual Analog Scale

  one year

• Number of the participants with adverse events

  one year

Study Arms (2)

Yunnan Baiyao toothpaste

EXPERIMENTAL

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

placebo toothpaste

ACTIVE COMPARATOR

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

Interventions

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.

Yunnan Baiyao 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.

placebo toothpaste

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking University: lead

MeSH Terms

Conditions

Stomatitis, Aphthous

Condition Hierarchy (Ancestors)

Stomatitis; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate professor

Study Record Dates

• First Submitted: July 23, 2012
• First Posted: July 30, 2012
• Study Start: March 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: July 30, 2012

Record last verified: 2012-07