Brief Title
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
Official Title
Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
Brief 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 .
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
Secondary Outcome
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer
Condition
Recurrent Aphthous Stomatitis
Intervention
chamomilla tincture mouthwash
Study Arms / Comparison Groups
chamomilla tincture mouthwash
Description: Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Drug
Estimated Enrollment
30
Start Date
April 2010
Completion Date
February 2011
Primary Completion Date
February 2011
Eligibility Criteria
Inclusion Criteria:• Confirmation of clinical diagnosis of aphthae
- Having the experience of oral aphthae at least once in a month
- Two weeks wash out periods after the last treatment
Exclusion Criteria:
- History of any systemic disease
- Using drugs which affect immune system
- Pregnancy and breast feeding
- Aphthous related syndromes
Gender
All
Ages
12 Years - 60 Years
Accepts Healthy Volunteers
No
Contacts
seyyed amir seyyedi, DDS-MSc, ,
Location Countries
Iran, Islamic Republic of
Location Countries
Iran, Islamic Republic of
Administrative Informations
NCT ID
NCT01122147
Organization ID
87034
Study Sponsor
Mashhad University of Medical Sciences
Study Sponsor
seyyed amir seyyedi, DDS-MSc, Principal Investigator, mashhad UMS
Verification Date
March 2010