The determination of therapeutic effect of bee propolis on the oral Lichen Planus treatment.
Design
Clinical trial with control group, with parallel group, double-blind, randomized, phase 3 on 40 patients. The random numbers table was used to randomize.
Settings and conduct
Patients who referred to the dental academic clinic or private centers in Bojnourd with OLP diagnosed by oral specialists, submit their initial information first and then in order to randomize the process, person "A" uses a computer and a table of random numbers to create a random sequence and people are divided into two "A" and "B" groups. Then, in the next step, person "B" prescribes medicine for one group and placebo for the other group. Group "A" consumes Propolis in the form of mouthwash with the dose of 500 mg according to the manufacturer's instructions and group "B", a placebo with the same form as the main drug is prescribed. The operator (the person prescribing the medicine) and the patient are not aware of any medicine or placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Patients who are diagnosed with OLP by an oral specialist.
People who have been willing to participate in the study and sign the informed consent form.
Exclusion criteria:
Patients with any past or present immunological disease or disorder.
Patients with any past or present allergic disease or disorder.
Pregnant and lactating women.
Intervention groups
The Intervention Group consumes propolis in the form of mouthwash with the dose of 500 mg according to the manufacturer's instructions.
The Control Group is given a placebo with a very similar form to the main drug and in the same way.
Main outcome variables
Extent of Atrophic areas;
Extent of Ulcerative areas;
Extent of Keratotic areas;
Intensity of pain and irritation;
Type of intervention;
Patient's Gender;
Patient's age.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210112050013N2
Registration date:2021-06-30, 1400/04/09
Registration timing:prospective
Last update:2021-06-30, 1400/04/09
Update count:0
Registration date
2021-06-30, 1400/04/09
Registrant information
Name
Javid Rasekhi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 58 3251 3000
Email address
j.rasekhi@nkums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-11, 1400/04/20
Expected recruitment end date
2021-08-01, 1400/05/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The assessment of the therapeutic effect of bee propolis on oral Lichen Planus treatment.
Public title
The assessment of the therapeutic effect of bee propolis on oral Lichen Planus treatment.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients who are diagnosed with OLP by an oral specialist.
People who have been willing to participate in the study and sign the informed consent form.
Exclusion criteria:
Patients with any past or present immunological disease or disorder.
Patients with any past or present allergic disease or disorder.
Pregnant and lactating women.
Susceptible Patients to bee sting and products.
Patients who have used systemic or topical Glucocorticosteroids at least over the past one month.
Patients with Lichen Planus extra-oral manifestations.
Patients with any continuous medication history.
Patients with oral Lichen Planus with evidence of dysplastic changes in the oral mucosa or a history of such changes in the past.
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Random numbers table
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: Uninformed about being in the Intervention or Control Group.
Researcher: Uninformed about the patients in Intervention or Control Group and prescribing drugs or placebo.
Outcome Evaluator: Uninformed about the patients in the Intervention or Control Group and prescribing drugs or placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of North Khorasan University of Medical Sciences
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
bojnourd
Province
North Khorasan
Postal code
9418654360
Approval date
2021-03-14, 1399/12/24
Ethics committee reference number
IR.NKUMS.REC.1399.144
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Extent of Atrophic areas: The area of Atrophic areas measured by caliper in square millimeters.Extent of Ulcerative areas: The area of the wound area measured by the caliper. Area of Keratotic areas: Area of Keratotic areas measured by caliper. Intensity of pain and irritation: The scale of pain and oral mucosa irritation that the patient reports according to VAS.
Timepoint
At the beginning of study and a month after the start of the study
Method of measurement
To measure the area of the affected areas, the largest lesion diameters are measured by a caliper and their product is considered as the area of the target area. If the patient has similar lesions in several areas, the area of all these areas will be added together and this amount will be reported. The scale of pain and irritation is measured by the Visual Analogue Scale. This method of measurement asks the patient to rate their pain and irritation from 0 (with no pain and irritation) to 10 (the most severe pain and irritation).
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group A consumes Propolis in the form of mouthwash with a dose of 500 mg, according to the manufacturer's instructions once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash.
Category
Treatment - Drugs
2
Description
Control group: Group B consumes placebo which is prescribed in the same form as the main drug and in the same way. Use mouthwash once or twice a day after brushing; First rinse the mouth with water or serum (normal saline) and then immediately use mouthwash with a plastic cup on the glass. Each mouthwash should last at least 2-3 minutes. Avoid eating and drinking for 30 minutes after using the mouthwash.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Bojnourd Dental School Clinic
Full name of responsible person
Dr. Javid Rasekhi
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
Bojnourd
Province
North Khorasan
Postal code
9418654360
Phone
+98 58 3272 9338
Email
forooghsajedii12@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Javid Rasekhi
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
bojnourd
Province
North Khorasan
Postal code
9418654360
Phone
+98 58 3272 9338
Email
forooghsajedii12@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Bojnourd 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
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Javid Rasekhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
Bojnourd
Province
North Khorasan
Postal code
9418654360
Phone
+98 58 3272 9338
Email
forooghsajedii12@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Javid Rasekhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
bojnourd
Province
North Khorasan
Postal code
9418654360
Phone
+98 58 3272 9338
Email
forooghsajedii12@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bojnourd University of Medical Sciences
Full name of responsible person
Dr. Javid Rasekhi
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
No. 12, Ferdowsi 19, South Ferdowsi St.
City
bojnourd
Province
North Khorasan
Postal code
9418654360
Phone
+98 58 3272 9338
Email
forooghsajedii12@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available