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Trial record 3 of 30 for:    "Aphthous stomatitis"

Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis

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ClinicalTrials.gov Identifier: NCT01293968
Recruitment Status : Completed
First Posted : February 11, 2011
Results First Posted : June 20, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Pantea Nazeman, Qazvin University Of Medical Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Supportive Care
Condition Aphthous Stomatitis
Interventions Drug: Ibuprofen, Diphenhydramine and Aluminium MgS
Drug: Diphenhydramine and Aluminium MgS
Enrollment 37

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Hide Arm/Group Description [Not Specified] [Not Specified]
Period Title: Overall Study
Started 20 17
Completed 17 14
Not Completed 3 3
Reason Not Completed
non-cooperation             3             3
Arm/Group Title Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS Total
Hide Arm/Group Description [Not Specified] [Not Specified] Total of all reporting groups
Overall Number of Baseline Participants 17 14 31
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
<=18 years
1
   5.9%
1
   7.1%
2
   6.5%
Between 18 and 65 years
16
  94.1%
13
  92.9%
29
  93.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 17 participants 14 participants 31 participants
32.4  (10.04) 32.0  (10.0) 32.2  (10.02)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 17 participants 14 participants 31 participants
Female
11
  64.7%
7
  50.0%
18
  58.1%
Male
6
  35.3%
7
  50.0%
13
  41.9%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Iran, Islamic Republic of Number Analyzed 17 participants 14 participants 31 participants
17 14 31
1.Primary Outcome
Title Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation
Hide Description 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
Time Frame four days after the start of the study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS
Arm/Group Title Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Hide Arm/Group Description:
the group received the study solution containing 5cc ibuprofen 100mg, 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
the group received the placebo solution containing 10 cc Diphenhydramine 25 mg and 10 cc AlMgS which was applied on the ulcers 30-60 minutes before meals, 3 times daily for 3 days
Overall Number of Participants Analyzed 17 14
Mean (95% Confidence Interval)
Unit of Measure: scores in Visual Analogue Scale
3.176
(1.169 to 5.183)
3.821
(2.028 to 5.614)
2.Secondary Outcome
Title The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation
Hide Description 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
Time Frame 4 days after the solution consumption
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Hide Arm/Group Description [Not Specified] [Not Specified]
All-Cause Mortality
Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/14 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Ibuprofen, Diphenhydramine and Aluminium MgS Diphenhydramine and Aluminium MgS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/17 (0.00%)   0/14 (0.00%) 
Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr.Katayun Borhanmojabi
Organization: Qazvin University of Medical Sciences
Phone: 09127841440
Responsible Party: Pantea Nazeman, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01293968     History of Changes
Other Study ID Numbers: qums353
First Submitted: February 10, 2011
First Posted: February 11, 2011
Results First Submitted: May 5, 2011
Results First Posted: June 20, 2012
Last Update Posted: June 20, 2012