Trial · NCT01293968
Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
NCT01293968, Phase 2, Completed, Qazvin University Of Medical Sciences; results first posted 2012-06-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis. Trials, record NCT01293968. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01293968
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis
- NCT number
- NCT01293968
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 37 participants, actual
- Lead sponsor
- Qazvin University Of Medical Sciences
- Conditions
- Aphthous Stomatitis
- Interventions
- Ibuprofen, Diphenhydramine and Aluminium MgS, Diphenhydramine and Aluminium MgS
- First posted
- 2011-02-11
- Last updated
- 2012-06-20
- Results first posted
- 2012-06-20
- Limitations and caveats
- Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | four days after the start of the study | 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 |
| Secondary | 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 | pain sensation was measured by VAS (Visual Analogue Scale) 4 days after the consumption of the solutions and the results of both drugs was analyzed |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | four days after the start of the study | The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS | scores in Visual Analogue Scale | MEAN |
| SECONDARY | 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 | scales in Visual Analogue Scale |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | Ibuprofen, Diphenhydramine and Aluminium MgS | 3.176 | 95% Confidence Interval 1.169 to 5.183 | scores in Visual Analogue Scale | |
| Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation | Diphenhydramine and Aluminium MgS | 3.821 | 95% Confidence Interval 2.028 to 5.614 | scores in Visual Analogue Scale |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ibuprofen, Diphenhydramine and Aluminium MgS | 20 | |
| Overall Study | STARTED | Diphenhydramine and Aluminium MgS | 17 | |
| Overall Study | COMPLETED | Ibuprofen, Diphenhydramine and Aluminium MgS | 17 | |
| Overall Study | COMPLETED | Diphenhydramine and Aluminium MgS | 14 | |
| Overall Study | NOT COMPLETED | Ibuprofen, Diphenhydramine and Aluminium MgS | 3 | |
| Overall Study | NOT COMPLETED | Diphenhydramine and Aluminium MgS | 3 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ibuprofen, Diphenhydramine and Aluminium MgS | ||
| Total, all-cause mortality | Diphenhydramine and Aluminium MgS | ||
| Total, other adverse events | Ibuprofen, Diphenhydramine and Aluminium MgS | 0 | 17 |
| Total, other adverse events | Diphenhydramine and Aluminium MgS | 0 | 14 |
| Total, serious adverse events | Ibuprofen, Diphenhydramine and Aluminium MgS | 0 | 17 |
| Total, serious adverse events | Diphenhydramine and Aluminium MgS | 0 | 14 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ibuprofen, Diphenhydramine and Aluminium MgS vs Diphenhydramine and Aluminium MgS: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01293968
GET https://conductscience.org/api/trials/v1/NCT01293968/registered