Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
1 other identifier
interventional
37
1 country
2
Brief Summary
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of recurrent aphthous stomatitis (RAS)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Nov 2010
Shorter than P25 for phase_2
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
February 10, 2011
CompletedFirst Posted
Study publicly available on registry
February 11, 2011
CompletedResults Posted
Study results publicly available
June 20, 2012
CompletedJune 20, 2012
May 1, 2012
2 months
February 10, 2011
May 5, 2011
May 16, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
pain sensation was measured by VAS (Visual Analogue Scale, a scaled ruler which the zero point displays the zone of lack of pain and the 10th point was considered as the zone of maximum pain)) 4 days after the consumption of the solution
four days after the start of the study
Secondary Outcomes (1)
The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
4 days after the solution consumption
Study Arms (2)
5cc Ibuprofen100mg,10 cc Diphenhydramine25mg,10 cc AlMgS550mg
EXPERIMENTAL100 cc Diphenhydramine, 25 mg and 100 cc AlMgS 550 mg
ACTIVE COMPARATORInterventions
3 times daily for 3 days
3 times daily for 3 days
Eligibility Criteria
You may qualify if:
- possessing at least one painful aphthous ulcer in the last 3 days
- older than 10 years of age
You may not qualify if:
- systemic disease or specific syndrome (such as Behcet's)
- pregnancy
- breastfeeding
- allergy to NSAIDs
- history of asthma, peptic ulcers, hepatic and renal failures and hemorrhagic disorders
- consumption of anti-inflammatory medications in the last 24 hours
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Dental faculty of Qazvin University of Medical Sciences
Qazvin, Qazvin Province, Iran
Qazvin University of Medical sciences
Qazvin, Qazvin Province, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.
Results Point of Contact
- Title
- Dr.Katayun Borhanmojabi
- Organization
- Qazvin University of Medical Sciences
Study Officials
- STUDY CHAIR
Katayun Borhanmojabi, D.D.S,M.S
QUMS
- STUDY DIRECTOR
Katayun Borhanmojabi, D.D.S,M.S
QUMS
- STUDY DIRECTOR
Marjan Nasiri asl, PhD
QUMS
- PRINCIPAL INVESTIGATOR
Faeze Mirmiran, D.D.S
QUMS
- PRINCIPAL INVESTIGATOR
Pantea Nazeman, student
QUMS
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Miss
Study Record Dates
First Submitted
February 10, 2011
First Posted
February 11, 2011
Study Start
November 1, 2010
Primary Completion
January 1, 2011
Study Completion
February 1, 2011
Last Updated
June 20, 2012
Results First Posted
June 20, 2012
Record last verified: 2012-05