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Evaluation of the Effectiveness of Crocin of Saffron in treatment of Burning Mouth Syndrome

Protocol summary

Study aim
Determination of the Effectiveness of Crocinic Saffron in Treatment of Burning Mouth Syndrome
Design
A double-blind, parallel randomized clinical trial (phase III) for 50 patients has been designed.
Settings and conduct
This double-blind randomized clinical trial is conducted at Mashhad Dental School, Iran. Participants and care providers and assessing outcomes and the statistician are blinded to the type of drug because drugs are placed in similar seal envelope packs.
Participants/Inclusion and exclusion criteria
The criteria for inclusion of patients in the study included: Daily bilateral burning sensation of oral mucosa for at least 4 to 6 months, persistent or increased burning intensity throughout the day, natural oral mucosa in clinical examination and the absence of any local or systemic causes to legitimize the irritation of the mouth, minimum burning intensity of 5 on the VAS scale for patients with BMS, not receiving any antidepressant treatment during the last 4 weeks . The criteria for excluding patients from the study were: the history of systemic disease characterized by burning mouth including diabetes, severe anemia, hypothyroidism, repetitious reflux or a history of micronutrient deficiency , severe psychological disorders such as severe depression, suicide thoughts and the history of hospitalization in psychiatric hospitals, pregnant patients or ones suspected to be pregnant, reports of any susceptibility to drugs or adverse effects, the use of monoamine oxidase inhibitors, tramadol, beta-blockers, benzodiazepines, tricyclic antidepressants at present or the recent month .
Intervention groups
control group:Citalopram (Sobhan Darou, Iran) once Daily.The initial dose is 10 mg and increased to 20 mg after a week. intervention group: 15 mg Crocin tablet (prepared by a pharmacologist colleague) twice daily.
Main outcome variables
pain and burning

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180416039318N1
Registration date: 2018-05-20, 1397/02/30
Registration timing: registered_while_recruiting

Last update: 2018-05-20, 1397/02/30
Update count: 0
Registration date
2018-05-20, 1397/02/30
Registrant information
Name
Ala Ghazi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9501
Email address
ghazial@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-25, 1397/02/05
Expected recruitment end date
2018-06-23, 1397/04/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the Effectiveness of Crocin of Saffron in treatment of Burning Mouth Syndrome
Public title
Effect of Saffron in treatment of Burning Mouth Syndrome
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Daily bilateral burning sensation of oral mucosa for at least 4 to 6 months, persistent or increased burning intensity throughout the day, natural oral mucosa in clinical examination and the absence of any local or systemic causes to legitimize the irritation of the mouth, minimum burning intensity of 5 on the VAS scale for patients with BMS, not receiving any antidepressant treatment during the last 4 weeks
Exclusion criteria:
the history of systemic disease characterized by burning mouth including diabetes, severe anemia, hypothyroidism, repetitious reflux or a history of micronutrient deficiency , severe psychological disorders such as severe depression, suicide thoughts and the history of hospitalization in psychiatric hospitals, pregnant patients or ones suspected to be pregnant, reports of any susceptibility to drugs or adverse effects, the use of monoamine oxidase inhibitors, tramadol, beta-blockers, benzodiazepines, tricyclic antidepressants at present or the recent month
Age
From 15 years old to 65 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
seal envelope
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the prepared medicine packs are the same for the two groups. Packages are coded from 1 to 40 by an individual outside the study and the mode and duration of consumption are given in the package. Packages are randomly delivered to patients. It should be noted that the psychiatrist, the participants and care providers and assessing outcomes and statistician are unaware of the type of prescribed medicine.
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences- Research Ethics Committee
Street address
Mashhad Dental School, Azadi Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
911735984
Approval date
2015-05-09, 1394/02/19
Ethics committee reference number
IR.mums.REC.1394.66

Health conditions studied

1

Description of health condition studied
Burning Mouth Syndrome
ICD-10 code
F59
ICD-10 code description
Unspecified behavioural syndromes associated with physiological disturbances and physical factors

Primary outcomes

1

Description
Burning and pain
Timepoint
at baseline and during treatment procedure (intervals of third, seventh and eleventh week after the beginning)
Method of measurement
visual analogue scale

Secondary outcomes

1

Description
Depression and anxiety
Timepoint
1. at baseline and during treatment procedure (intervals of the third, seventh and eleventh week after the beginning)
Method of measurement
Hamilton questionnaire

Intervention groups

1

Description
Intervention group: tablet of Saffron Crocin 15 mg (prepared by a pharmacologist colleague) is prescribed twice daily. Consumption duration is determined to be 11 weeks.The severity of burning, depression, and anxiety of patients are measured and recorded at baseline and intervals of the third, seventh and eleventh week after the beginning.
Category
Treatment - Drugs

2

Description
Control group: Citalopram (Sobhan Darou, Iran) is prescribed once daily. The initial dose is 10 mg and increased to 20 mg after a week. Consumption duration is determined to be 11 weeks. The severity of burning, depression, and anxiety of patients are measured and recorded at intervals of the third, seventh and eleventh week after the beginning.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral and maxillofacial Diseases Department of Mashhad Dental School
Full name of responsible person
Dr. Atessa Pakfetrat
Street address
Mashhad Dental School, Azadi Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Fax
+98 51 3882 9500
Email
pakfetrata@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr Mohsen Tafaghodi
Street address
Mashhad University of Medical Sciences, Daneshgah St.
City
Mashhad
Province
Razavi Khorasan
Postal code
91388-13944
Phone
+98 51 3882 3255
Email
tafaghodiM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Roya zamani
Position
Associate
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Azadi Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
ZamaniR921@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Atessa Pakfetrat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Azadi Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
pakfetrata@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ala Ghazi
Position
assistant
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Mashhad Dental School, Azadi Square, Vakilabad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948959
Phone
+98 51 3882 9501
Email
ghazial@mums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Some data including demographic properties, signs and symptoms
When the data will become available and for how long
two months after article publication.
To whom data/document is available
academic researchers
Under which criteria data/document could be used
It is permitted to use the data in other studies with reference.
From where data/document is obtainable
Dr Roya Zamani , ZamaniR921@mums.ac.ir
What processes are involved for a request to access data/document
sending email to authors. the authors will send data via email during 4 weeks.
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