Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

Learn more about:

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


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


Recurrent Aphthous Stomatitis


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


* 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


Estimated Enrollment


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




12 Years - 60 Years

Accepts Healthy Volunteers



seyyed amir seyyedi, DDS-MSc, , 

Location Countries

Iran, Islamic Republic of

Location Countries

Iran, Islamic Republic of

Administrative Informations



Organization ID


Study Sponsor

Mashhad University of Medical Sciences

Study Sponsor

seyyed amir seyyedi, DDS-MSc, Principal Investigator, mashhad UMS

Verification Date

March 2010