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Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

This study has been completed.
Information provided by:
Mashhad University of Medical Sciences Identifier:
First received: May 7, 2010
Last updated: August 1, 2011
Last verified: March 2010
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 Intervention Phase
Recurrent Aphthous Stomatitis Drug: chamomilla tincture mouthwash Drug: placebo mouthwash Phase 1

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • 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:
  • 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

Enrollment: 30
Study Start Date: April 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
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Please refer to this study by its identifier: 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
  More Information

Responsible Party: Dental Research center of Mashhad Dental School, Mashhad University of Medical Science Identifier: NCT01122147     History of Changes
Other Study ID Numbers: 87034
Study First Received: May 7, 2010
Last Updated: August 1, 2011

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

Additional relevant MeSH terms:
Stomatitis, Aphthous
Mouth Diseases
Stomatognathic Diseases processed this record on September 21, 2017