Trial record 6 of 18 for:    "Aphthous stomatitis"

Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae

This study has been completed.
Sponsor:
Information provided by:
Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01122147
First received: May 7, 2010
Last updated: August 1, 2011
Last verified: March 2010
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: Yes ]
    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

  Eligibility

Ages Eligible for Study:   12 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01122147

Locations
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
Investigators
Principal Investigator: seyyed amir seyyedi, DDS-MSc mashhad UMS
  More Information

No publications provided

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

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

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

ClinicalTrials.gov processed this record on August 28, 2014