Back to resultsClinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
Primary Purpose
Recurrent Aphthous Stomatitis
Status
Completed
Phase
Phase 1
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
chamomilla tincture mouthwash
placebo mouthwash
Sponsored by
About this trial
This is an interventional treatment trial for Recurrent Aphthous Stomatitis focused on measuring Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
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
Sites / Locations
- Mashhad University of Madical Science,Research Center of Mashhad Dental School
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
chamomilla tincture mouthwash
placebo mouth wash
Arm Description
Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.
Outcomes
Primary Outcome Measures
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
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
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly
Full Information
NCT ID
NCT01122147
First Posted
May 7, 2010
Last Updated
August 1, 2011
Sponsor
Mashhad University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01122147
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2010
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Mashhad University of Medical Sciences
4. Oversight
5. Study Description
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 .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Recurrent Aphthous Stomatitis
Keywords
Aphthous stomatitis; Herbal medicines; Matricaria Chamomilla
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
chamomilla tincture mouthwash
Arm Type
Active Comparator
Arm Description
Chamomile comprises bisaboloids, matricine and chamazulene, flavonoids, and cumarins having therapeutical anti-inflammatory, analgesic, musculotropic, and spasmolytic action
Arm Title
placebo mouth wash
Arm Type
Placebo Comparator
Arm Description
placebo mouthwash is produced with the same taste and smell for using in placebo/ control group.
Intervention Type
Drug
Intervention Name(s)
chamomilla tincture mouthwash
Intervention Description
The patient is directed to mouth wash chamomilla tincture lightly three times a day,ten drops for each time,until ulcers completely heal
Intervention Type
Drug
Intervention Name(s)
placebo mouthwash
Intervention Description
The patient is directed to use placebo mouthwash three times a day, ten drops for each time,until the ulcers completely heal
Primary Outcome Measure Information:
Title
protocol designed to evaluate the effect of fluid extract from Chamomilla recutita's on treatment of aphthous stomatitis
Description
This study evaluates the fluid extract from Chamomilla recutita's effectiveness on healing rate of aphthous stomatitis, and reducing ulcer size
Time Frame
3 months
Secondary Outcome Measure Information:
Title
This study aimed to evaluate the efficacy of chamomile mouthwash of decreasing the pain and frequency of oral aphthous ulcer
Description
In the present work the Analogical Visual Scale is used TO evaluate pain,and we also record the frequency of ulcers monthly
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
seyyed amir seyyedi, DDS-MSc
Organizational Affiliation
mashhad UMS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mashhad University of Madical Science,Research Center of Mashhad Dental School
City
Mashhad
State/Province
Khorasan Razavi
ZIP/Postal Code
91735
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Clinical Evaluation of Fluid Extract of Chamomilla Tincture for Oral Aphthae
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