Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01122147
Recruitment Status : Completed
First Posted : May 13, 2010
Last Update Posted : August 2, 2011
Information provided by:
Mashhad University of Medical Sciences

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 .

Condition or disease Intervention/treatment Phase
Recurrent Aphthous Stomatitis Drug: chamomilla tincture mouthwash Drug: placebo mouthwash Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Phase 1 Evaluation of Therapeutic Effect of Chamomilla Tincture Mouthwash on Oral Aphthae
Study Start Date : April 2010
Actual Primary Completion Date : February 2011
Actual Study Completion Date : February 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Canker Sores
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: chamomilla tincture mouthwash
Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
Drug: chamomilla tincture mouthwash
The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal
Placebo Comparator: placebo mouth wash
placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.
Drug: placebo mouthwash
The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer [ Time Frame: 3 months ]
    In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly

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Ages Eligible for Study:   12 Years to 60 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01122147

Iran, Islamic Republic of
Mashhad University of Madical Science,Research Center of Mashhad Dental School
Mashhad, Khorasan Razavi, Iran, Islamic Republic of, 91735
Sponsors and Collaborators
Mashhad University of Medical Sciences
Principal Investigator: seyyed amir seyyedi, DDS-MSc mashhad UMS

Responsible Party: Dental Research center of Mashhad Dental School, Mashhad University of Medical Science Identifier: NCT01122147     History of Changes
Other Study ID Numbers: 87034
First Posted: May 13, 2010    Key Record Dates
Last Update Posted: August 2, 2011
Last Verified: March 2010

Keywords provided by Mashhad University of Medical Sciences:
Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla

Additional relevant MeSH terms:
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases