Phase 2
Completed N=37
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
Aphthous Stomatitis
Source: ClinicalTrials.gov NCT01293968 ↗
Enrolled (actual)
37
Serious AEs
0.0%
Results posted
Jun 2012
Primary outcomePrimary: 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
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)
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 |
— | — |
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. Informational only — not medical advice.