Evaluation of the clinical effectiveness of frankincense extract in the treatment of oral aphthous ulcers
Design
Two arm parallel group randomized placebo-controlled clinical trial, phase 3 on 50 patients. Block randomization method with blocks of 4 was used for randomization.
Settings and conduct
The study was performed at the dental clinic of Isfahan University of Medical Sciences.The subjects in experimental and control groups were instructed to use Boswellia and placebo orally disintegration tablets (ODTs), respectively, 4 times daily for 3 days. The severity of pain and size of the ulcer before the intervention (day 0) and at the beginning of the second and fourth days (end of treatment) were recorded for each patient.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1. Age of 18 years or more
2. Having 1 to 5 oral aphthous ulcers
3. No more than 48 hours of aphthous occurrence
Exclusion criteria:
1. Underlying aphthous ulcer-inducing disease
2. Pregnancy
3. Lactation
4. Receiving any anti-inflammatory or immunosuppressive drug within the last 2 weeks
5. Rreceiving any systemic antibiotic within the last 2 weeks
6. Treatment of aphthous ulcer with any other drug within recent 3 days
Intervention groups
Experimental group: orally disintegrating tablets of frankincense extract (manufactured by the faculty of Pharmacy) standardized based on 5.90% w/w of 11-keto-beta-boswellic acid, 4 times daily
Control group: orally disintegrating tablets of placebo (manufactured by the faculty of Pharmacy), 4 times daily
Main outcome variables
Ulcer size; Pain severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150721023282N10
Registration date:2020-04-25, 1399/02/06
Registration timing:retrospective
Last update:2020-04-25, 1399/02/06
Update count:0
Registration date
2020-04-25, 1399/02/06
Registrant information
Name
Rasool Soltani
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3792 7067
Email address
soltani@pharm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-11-20, 1395/08/30
Actual recruitment start date
2017-12-22, 1396/10/01
Actual recruitment end date
2018-08-21, 1397/05/30
Trial completion date
2018-08-21, 1397/05/30
Scientific title
Evaluation of the effectiveness of Boswellia serrata extract (frankincense) in the treatment of oral aphthous ulcers compared to placebo
Public title
The effectiveness of frankincense in the treatment of oral aphthae
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age of 18 years or more
Having 1 to 5 oral aphthous ulcers
No more than 48 hours of aphthous occurrence;
Not receiving any systemic antibiotic within the last 2 weeks
Block randomization method was used in which blocks of 4 were used.
Blinding (investigator's opinion)
Double blinded
Blinding description
Drug (frankincense) and placebo tablets will be fully similar and packaged in similar containers. The patient, the prescriber (physician), data analyst, and the laboratory personnel will be blind to the content of containers and intervention type.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Vice-chancellery for research, Isfahan University of Medical Sciences, Hezar-Jerib Ave., Isfahan
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2017-11-26, 1396/09/05
Ethics committee reference number
IR.MUI.REC.1396.3.572
Health conditions studied
1
Description of health condition studied
Oral aphthous ulcer
ICD-10 code
K12.0
ICD-10 code description
Recurrent oral aphthae
Primary outcomes
1
Description
Oral aphthous ulcer size
Timepoint
Before the intervention, 2 and 4 days after the start of intervention
Method of measurement
Dental caliper
2
Description
Ulcer pain severity
Timepoint
Before the intervention, 2 and 4 days after the start of intervention
Method of measurement
Visual analogue scale (VAS)
Secondary outcomes
1
Description
The number of cases with complete ulcer healing
Timepoint
End of ontervention (4th day)
Method of measurement
Observation
Intervention groups
1
Description
Intervention group: orally disintegrating tablets of frankincense extract (manufactured by the faculty of Pharmacy) standardized based on 5.90% w/w of 11-keto-beta-boswellic acid, 4 times daily
Category
Treatment - Drugs
2
Description
Control group: orally disintegrating tablets of placebo (manufactured by the faculty of Pharmacy), 4 times daily
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dental Clinic of Isfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Street address
Faculty of Dentistry, Isfahan University of Medical Sciences, Soffeh Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3303 3950
Email
soltani@pharm.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjooy Javanmard
Street address
Isfahan University of Medical Sciencesو Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3668 8138
Email
sh_haghjoo@med.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Assiciate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Faculty of Pharmacy, Isfahan University of Medical Sciences, Hezar-Jerib Avenue
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
+98 31 3668 0011
Email
soltani@pharm.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
Email
soltani@pharm.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Rasool Soltani
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Department of Clinical Pharmacy, Faculty of Pharmacy, Isfahan University of Medical Sciences
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3792 7067
Fax
Email
soltani@pharm.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD