Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

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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