Trial Outcomes & Findings for Therapeutic Effects of "Ibuprofen, Diphenhydramine and Aluminium MgS" on Recurrent Aphthous Stomatitis (NCT NCT01293968)

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

37 participants

Primary outcome timeframe

four days after the start of the study

Results posted on

2012-06-20

Participant Flow

Participant milestones

Participant milestones
Measure	Ibuprofen, Diphenhydramine and Aluminium MgS	Diphenhydramine and Aluminium MgS
Overall Study STARTED	20	17
Overall Study COMPLETED	17	14
Overall Study NOT COMPLETED	3	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Ibuprofen, Diphenhydramine and Aluminium MgS	Diphenhydramine and Aluminium MgS
Overall Study non-cooperation	3	3

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ibuprofen, Diphenhydramine and Aluminium MgS n=17 Participants	Diphenhydramine and Aluminium MgS n=14 Participants	Total n=31 Participants Total of all reporting groups
Age, Categorical <=18 years	1 Participants n=93 Participants	1 Participants n=4 Participants	2 Participants n=27 Participants
Age, Categorical Between 18 and 65 years	16 Participants n=93 Participants	13 Participants n=4 Participants	29 Participants n=27 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants
Age Continuous	32.4 years STANDARD_DEVIATION 10.04 • n=93 Participants	32.0 years STANDARD_DEVIATION 10.0 • n=4 Participants	32.2 years STANDARD_DEVIATION 10.02 • n=27 Participants
Sex: Female, Male Female	11 Participants n=93 Participants	7 Participants n=4 Participants	18 Participants n=27 Participants
Sex: Female, Male Male	6 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants
Region of Enrollment Iran, Islamic Republic of	17 participants n=93 Participants	14 participants n=4 Participants	31 participants n=27 Participants

PRIMARY outcome

Timeframe: four days after the start of the study

Population: The intention of the study is to study the effects of Ibuprofen, Diphenhydramine and Aluminium MgS in decreasing the signs of RAS

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

Outcome measures

Outcome measures
Measure	Ibuprofen, Diphenhydramine and Aluminium MgS n=17 Participants 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	Diphenhydramine and Aluminium MgS n=14 Participants 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
Effect of Ibuprofen, Diphenhydramine and Aluminium MgS Measured on Decrease in Pain Level and Burning Sensation	3.176 scores in Visual Analogue Scale Interval 1.169 to 5.183	3.821 scores in Visual Analogue Scale Interval 2.028 to 5.614

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome data not reported

Adverse Events

Ibuprofen, Diphenhydramine and Aluminium MgS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Diphenhydramine and Aluminium MgS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr.Katayun Borhanmojabi

Qazvin University of Medical Sciences

Phone: 09127841440

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place