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

History of Changes

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:

MedlinePlus related topics: Canker Sores

U.S. FDA Resources

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

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 May 16, 2013

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