Recurrent Aphthous StomatitisPhase 2NCT01652625
Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis
A Phase 2 study testing Yunnan Baiyao toothpaste in people with Recurrent Aphthous Stomatitis, run by Peking University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- Yunnan Baiyao toothpaste
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 227 participants
- Where
- No sites listed yet
- Study dates
- Mar 2010to Mar 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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.
About this study
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
- Being tested
- Yunnan Baiyao toothpaste, Placebo toothpaste
- Keywords
- Yunnan Baiyao, recurrent aphthous stomatitis, clinical trial
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yunnan Baiyao toothpasteDrug
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 toothpasteDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one year
Secondary outcomes (2)
Pain Scores with Visual Analog Scale
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.
Measured: one year
Number of the participants with adverse events
Any noted adverse reactions were recorded.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2012 (estimated)
- Study startMar 2010
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent Aphthous StomatitisStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 227 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaosong Liu, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01652625
- Sponsor's protocol ID
- Peking University
- Status last verified
- Jul 2012
- First submitted
- 23 Jul 2012
- Last updated
- 30 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Study of Yunnan Baiyao on Minor Recurrent Aphthous Stomatitis
- ClinicalTrials.gov ID
- NCT01652625
- Acronym / sponsor ID
- Peking University
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Yunnan Baiyao, recurrent aphthous stomatitis, clinical trial
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 227 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jul 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yunnan Baiyao toothpaste | Experimental | Drug: Yunnan Baiyao toothpasteThe toothpaste containing 6.5 milligrams of Yunnan Baiyao was used twice daily as part of the patient's routine oral hygiene for 5 days. |
| placebo toothpaste | Active comparator | Drug: Placebo toothpasteOne 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yunnan Baiyao toothpasteThe 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. | Drug | Yunnan Baiyao toothpaste |
| Placebo toothpasteOne 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. | Drug | placebo toothpaste |
Primary outcome
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.
2 secondary outcomes
Pain Scores with Visual Analog Scale
Time frame: one year
Number of the participants with adverse events
Time frame: one year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Yunnan Baiyao toothpaste in people with Recurrent Aphthous Stomatitis, run by Peking University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jul 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ulcer size (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2012.