Protocol summary

Summary
Recurrent aphthous stomatitis, or RAS, is a common oral disorder of uncertain etiopathogenesis for which symptomatic therapy only is available. There are several proposed medication for treatment but thier efficacy are not ideal. The aim of this study is to evaluate the clinical efficacy of turmeric in the treatment of recurrent aphthous stomatitis in a double blind, placebo controlled and randomized trial. Methods: Setting A two week, double blind, placebo controlled and randomized trial in the ward of oral medicine at Tehran University of Medical Sciences. Study population Patients between 20 and 45 years old will be included if they present with 1–5 aphthous ulcers of less than 24 h duration. The ulcers diameter will not be greater than 6 mm and they do not suffer from acute or chronic diseases of the oral mucosa Patients will be excluded from the study if they have concurrent clinical conditions including serious liver, kidney, and heart dysfunctions or if they have ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohn’s disease, Behcet’s syndrome, or serious anaemia. To minimize the effect of confounding variables in the psycho- physiological component of the study, the patients should not have a history of alcohol or drug abuse and should not take any narcotic analgesics. Patients will be excluded if they have a history of systemic immunosuppressive therapy. Patients will be assigned randomly (by computer-generated random number list), to receive turmeric or placebo (25 in each group) Measurements After enrolment, the size of ulcers will be measured by the investigator, and pain was evaluated by the subjects based on visual. analogue scale (VAS) before drug application (day 0) and at days 2, 6, 10 and 14.

General information

Acronym
Turmeric trial
IRCT registration information
IRCT registration number: IRCT201107311556N28
Registration date: 2011-07-31, 1390/05/09
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2011-07-31, 1390/05/09
Registrant information
Name
Shahin Akhondzadeh
Name of organization / entity
Roozbeh Psychiatric Hospital, Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 2222
Email address
s.akhond@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
By a grant from Erphan Teb
Expected recruitment start date
2011-07-31, 1390/05/09
Expected recruitment end date
2011-09-30, 1390/07/08
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Turmeric in the treatment of recurrent aphthous stomatitis: a double blind and placebo controlled trial
Public title
Turmeric in the treatment of recurrent aphthous stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
50 Patients between 20 and 45 years old will be included if they present with 1–5 aphthous ulcers of less than 24 h duration. The ulcers diameter will not be greater than 6 mm and they do not suffer from acute or chronic diseases of the oral mucosa Patients will be excluded from the study if they have concurrent clinical conditions including serious liver, kidney, and heart dysfunctions or if they have ulcers as a manifestation of a systemic disease process such as ulcerative colitis, Crohn’s disease, Behcet’s syndrome, or serious anaemia. To minimize the effect of confounding variables in the psycho- physiological component of the study, the patients should not have a history of alcohol or drug abuse and should not take any narcotic analgesics. Patients will be excluded if they have a history of systemic immunosuppressive therapy.
Age
From 20 years old to 45 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz Blvd
City
Tehran
Postal code
Approval date
2011-04-21, 1390/02/01
Ethics committee reference number
13676

Health conditions studied

1

Description of health condition studied
Recurrent aphthous stomatitis
ICD-10 code
K 12.0
ICD-10 code description
Recurrent oral aphthae

Primary outcomes

1

Description
Decrease of pain
Timepoint
Before treatment and days 2, 4, 6, 10 and 14 after treatment
Method of measurement
VAS rating scale

Secondary outcomes

1

Description
Size of ulcers
Timepoint
Before drug application (day 0) and at days 2, 6, 10 and 14
Method of measurement
Diameters

Intervention groups

1

Description
Intervention group: Turmeric Jel (topical) three time a day by a swap
Category
Treatment - Drugs

2

Description
Control group: Placebo gel, three time a day (topical) by a swap
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral Medicine Ward, Imam Khomeni Complex Hospital
Full name of responsible person
Dr. Soheila Mani far
Street address
Imam Khomeni Complex Hospital
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Erphan Teb
Full name of responsible person
Dr. Hamid Shirazi
Street address
No. 4, Barmak Valley, Alvan Street, Arjantine Sq.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Erphan Teb
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehtan University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Psychiatric Research Center, Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
S.akhond@sina.tums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Shahin Akhondzadeh
Position
Prof. of Clinical Psychopharmacology
Other areas of specialty/work
Street address
Psychiatric Research Center, Roozbeh Hospital
City
Tehran
Postal code
Phone
+98 21 6641 8466
Fax
Email
s.akhond@sina.tums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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