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A comparison of the effect of oral Curcumin and Prednizolon on pain relief and size of the lesions in patients with Oral Lichen Planus lesions who refer to OMF center of Dental University of Gilan and private office in Rasht 1396-97

Protocol summary

Study aim
The purpose of this study is to compare of the effect of 80 mg oral Curcumin capsule, made by Eksir Nano Sina Company and 10mg Prednizolon, on pain & size of lesions of Oral lichen planus.
Design
Phase 3 clinical trial having 2 groups of 28 members, double blinded and randomized with block identifier, block size, sequence within block, treatment, code.
Settings and conduct
56 Patients in divides into 2 groups of 28,that one of them will recieve nano corcumin cap or 10mg prednizolone for 1 month. examination and evaluation in initial of study then in 1,2,4 week intervals will be record. Information of randomizing will just give to the secretory & drugs will be count and put into an envelope for each person. information for correct use of drugs will be give to patients separately in another room.
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with Oral lichen planus clinicaly and histologically. Exclusion criteria: pregnancy,breastfeeding,patients who take Corticosteroid.patients with increased hepatic enzyme and patients who take anti coagulation and anti platelet drug, like Warfarin.orthodontic appliences.patients with peptic ulcer, gall-bladder stone.existance of neoplasms or viral infections.receiving topical treatment for OLP during last 2 weeks or systemic treatment of OLP during last 4 weeks.consumption of Azathioprine, Cyclosporine, UVA,PUVA or UVB during last month.the presence of allergies to Corticosteroids or herbal drugs like Curcumin.
Intervention groups
Group 1: Consumption of 80mg Curcumin capsules in nano form once a day after breakfast for 1 month Group 2: Consumption of two 5mg Prednizolone tablet after breakfast for 1 month, and for tapering 5mg daily Prednizolone for 10 days.
Main outcome variables
Pain levels will be evaluate with VAS scale. Size of lesions will be evaluate with Thongprasom scale.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20100101002950N5
Registration date: 2019-02-09, 1397/11/20
Registration timing: prospective

Last update: 2019-02-09, 1397/11/20
Update count: 0
Registration date
2019-02-09, 1397/11/20
Registrant information
Name
Sayed Javad Kia
Name of organization / entity
Guilan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1323 0775
Email address
djavadkia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2019-05-21, 1398/02/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparison of the effect of oral Curcumin and Prednizolon on pain relief and size of the lesions in patients with Oral Lichen Planus lesions who refer to OMF center of Dental University of Gilan and private office in Rasht 1396-97
Public title
A comparison of the effect of oral Curcumin and Prednizolon on pain relief and size of the lesions in patients with Oral Lichen Planus lesions who refer to OMF center of Dental University of Gilan and private office in Rasht 1396-97
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with Oral lichen planus(confirmed by clinical examination, biopsy and histopathological evaluation)
Exclusion criteria:
Pregnancy Breastfeeding Patients who take corticosteroid Patients with increased hepatic enzyme and patients who take anti coagulation and anti platelet drug, like Warfarin. Orthodontic appliences Patients with Peptic ulcer, Gall-bladder stone Existance of any neoplasms or viral infections Receiving topical treatment for OLP during last 2 weeks or systemic treatment of OLP during last 4 weeks Consumption of Azathioprine, Cyclosporine, UVA,PUVA or UVB during last month The presence of allergies to Corticosteroids or herbal drugs like Curcumin
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
  • Data analyser
  • Data and Safety Monitoring Board
Sample size
Target sample size: 56
Randomization (investigator's opinion)
Randomized
Randomization description
For divition of participants into 2 random groups of 28 members, first give each participant number 1 to 56. then we will devide them randomly(complete randomization excel file is available) : block identifier, block size, sequence within block, treatment, code • 1, 4, 1, Group B, OK1 • 1, 4, 2, Group A, NY0 • 1, 4, 3, Group A, CA8 • 1, 4, 4, Group B, UP6 • 2, 4, 1, Group B, LA0 • 2, 4, 2, Group A, VK2 • 2, 4, 3, Group B, AY0 • 2, 4, 4, Group A, LW6 • 3, 4, 1, Group A, CM7 • 3, 4, 2, Group B, BX0
Blinding (investigator's opinion)
Double blinded
Blinding description
The study will be double-blinde. the information of randomization just will be give to the secretory and drugs for 2 groups will be count and put into an envelope for each person. information for correct use of drugs will be give to patients separately in another room.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Sciences
Street address
Opposite of Sepah bank, Western Shahid Beheshti Blv
City
Rasht
Province
Guilan
Postal code
41941-73774
Approval date
2018-11-02, 1397/08/11
Ethics committee reference number
IR.Gums.Rec.1397.295

Health conditions studied

1

Description of health condition studied
Oral Lichen Planus
ICD-10 code
L43
ICD-10 code description
Lichen planus

Primary outcomes

1

Description
Severity of pain
Timepoint
Before treatment and 1,2,4 week after treatment
Method of measurement
Use of Visual Analogue Scale(VAS)

Secondary outcomes

1

Description
Size of the Lichen planus lesions
Timepoint
Before treatment and 1,2,4 week after treatment
Method of measurement
Tongprasom scale(0-5)

Intervention groups

1

Description
Intervention group: Consumption of 80 mg oral Curcumin capsule once a day for 1 month
Category
Treatment - Drugs

2

Description
Control group: Consumption of 2 capsules of Prednizolone 5mg once a day for 1 month and after that for 10 days 5mg Prednizolone per day for tapering
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Dental school, Guilan University of Medical Sciences
Full name of responsible person
Dr Seyad Javad Kia
Street address
Imam Khomeyni Street
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3332 0060
Fax
+98 13 3348 6423
Email
dental@gums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Rasool Tabari
Street address
Opposite of Sepah bank, Western Shahid Beheshti Blv, Rasht
City
Rasht
Province
Guilan
Postal code
41941-73774
Phone
+98 13 3333 5820
Email
research@gums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rasht 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
Rasht University of Medical Sciences
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pardis, Emam Ave
City
Rasht
Province
Guilan
Postal code
41941-73773
Phone
+98 13 3323 7877
Email
djavadkia@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pardis, Emam Ave
City
Rasht
Province
Guilan
Postal code
41941-73773
Phone
+98 13 3323 7877
Email
djavadkia@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Dr Seyed Javd Kia
Position
Assistant proffessor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Pardis, Emam Ave
City
Rasht
Province
Guilan
Postal code
41941-73773
Phone
+98 13 3323 7877
Email
djavadkia@yahoo.com

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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
data are shareable after making them unidentifiable.
When the data will become available and for how long
accessibility starts from 6 month after publish
To whom data/document is available
data will be accessible for researchers of universal and scientific institution.
Under which criteria data/document could be used
they can use them with reference
From where data/document is obtainable
dr seyed javad kia djavadkia@yahoo.com
What processes are involved for a request to access data/document
after receiving the request, data will be send to applier during 1 month
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