Phase 2
N=37
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Aphthous Stomatitis
Bottom Line
View on ClinicalTrials.gov: NCT01293968 ↗Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcome: Primary: Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation — 3.176; 3.821 scores in Visual Analogue Scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Ibuprofen, Diphenhydramine and Aluminium MgS (Drug); Diphenhydramine and Aluminium MgS (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Qazvin University Of Medical Sciences
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation |
3.176; 3.821 | — |
| SECONDARY The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation |
— | — |
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)
Eligibility Criteria
Inclusion Criteria
- possessing at least one painful aphthous ulcer in the last 3 days
- older than 10 years of age
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT01293968). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.