ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 28 for:    "Aphthous stomatitis"

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Ibuprofen, Diphenhydramine and Aluminium MgS No text entered.
Diphenhydramine and Aluminium MgS No text entered.

Participant Flow:   Overall Study
    Ibuprofen, Diphenhydramine and Aluminium MgS   Diphenhydramine and Aluminium MgS
STARTED   20   17 
COMPLETED   17   14 
NOT COMPLETED   3   3 
non-cooperation                3                3 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Ibuprofen, Diphenhydramine and Aluminium MgS No text entered.
Diphenhydramine and Aluminium MgS No text entered.
Total Total of all reporting groups

Baseline Measures
   Ibuprofen, Diphenhydramine and Aluminium MgS   Diphenhydramine and Aluminium MgS   Total 
Overall Participants Analyzed 
[Units: Participants]
 17   14   31 
Age 
[Units: Participants]
     
<=18 years   1   1   2 
Between 18 and 65 years   16   13   29 
>=65 years   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation)
 32.4  (10.04)   32.0  (10.0)   32.2  (10.02) 
Gender 
[Units: Participants]
     
Female   11   7   18 
Male   6   7   13 
Region of Enrollment 
[Units: Participants]
     
Iran, Islamic Republic of   17   14   31 


  Outcome Measures

1.  Primary:   Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation   [ Time Frame: four days after the start of the study ]

2.  Secondary:   The Effect of Ibuprofen, Diphenhydramine, Aluminium MgS and Diphenhydramine and Aluminium MgS in Decreasing the Pain Level and Burning Sensation   [ Time Frame: 4 days after the solution consumption ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Small number of population. Studying just one concentration of Ibuprofen. Lack of a placebo.


  More Information

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
e-mail: ka.mojabi@yahoo.com



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