Recurrent Aphthous StomatitisPhase 1NCT01122147
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
A Phase 1 study testing chamomilla tincture mouthwash in people with Recurrent Aphthous Stomatitis, run by Mashhad University of Medical Sciences at 1 site in Iran.
Trial summary
Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis . Read more about this study
- Who is it for?
- Ages 12 to 60 years
- Conditions the study is for
- Recurrent Aphthous Stomatitis
- What is being tested?
- chamomilla tincture mouthwash
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- Apr 2010to Feb 2011
- Phase
- Phase 1
- 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 12 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
None listed.
Who cannot join
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
Trial locations and contacts
1 site in 1 country.
Iran1 site
Mashhad University of Madical Science,Research Center of Mashhad Dental School
Mashhad, Razavi Khorasan Province, 91735
About this study
Official title: Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
Recurrent aphthous stomatitis is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .
- Conditions
- Recurrent Aphthous Stomatitis
- Being tested
- chamomilla tincture mouthwash, placebo mouthwash
- Keywords
- Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
- Medical subject headings
- Stomatitis, Aphthous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chamomilla tincture mouthwashDrug
The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal
placebo mouthwashDrug
The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal
| Study group | Role | What they receive |
|---|---|---|
| chamomilla tincture mouthwash | Active comparator | Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action Receives: Drug: chamomilla tincture mouthwash |
| placebo mouth wash | Placebo comparator | placebo mouthwash is produced with the same taste and smell for using in placebo/ control group. Receives: Drug: placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size
Measured: 3 months
Secondary outcomes (1)
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2010 (estimated)
- Study startApr 2010
- Primary completionFeb 2011
- Study completionFeb 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Investigators
- seyyed amir seyyedi, DDS-MSc, Principal investigator, mashhad UMS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01122147
- Sponsor's protocol ID
- 87034
- Status last verified
- Mar 2010
- First submitted
- 7 May 2010
- Last updated
- 2 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
- ClinicalTrials.gov ID
- NCT01122147
- Acronym / sponsor ID
- 87034
- Conditions
- Recurrent Aphthous Stomatitis
- Keywords
- Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 13 May 2010 (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 is a difficult to treat and quite common chronic inflammatory disease of the oral mucosa. This study evaluates the fluid extract from Chamomilla recutita's safety and effectiveness in treatment of aphthous stomatitis .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| chamomilla tincture mouthwash | Active comparator | Drug: chamomilla tincture mouthwashChamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action |
| placebo mouth wash | Placebo comparator | Drug: placebo mouthwashplacebo mouthwash is produced with the same taste and smell for using in placebo/ control group. |
Who may qualify
- Ages
- 12 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
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 |
|---|---|---|
| chamomilla tincture mouthwashThe patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal | Drug | chamomilla tincture mouthwash |
| placebo mouthwashThe patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal | Drug | placebo mouth wash |
Primary outcome
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
Time frame: 3 months
This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size
1 secondary outcome
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer
Time frame: 3 months
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 2 Aug 2011.
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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.
seyyed amir seyyedi, DDS-MSc principal investigator
mashhad UMS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing chamomilla tincture mouthwash in people with Recurrent Aphthous Stomatitis, run by Mashhad University of Medical Sciences at 1 site in Iran.
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 0 inclusion and 4 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 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis (time frame: 3 months). 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 2 Aug 2011.