Protocol summary

Summary
The aim of this study was to determine the effect of 80 mg oral curcumin capsule, made by Eksir Nano Sina Company, on treatment of oral lichen planus of patients referred to center of oral and maxillofacial disease of guilan dentistry faculty. this study is accomplished, single blind, uni center, without any randomization and in 3th phase of clinical trial.13 patients with oral lichen planus without any systemic disease will be enrolled in this study. Patients didn’t use local corticosteroid from 2 weeks ago and systemic corticosteroid from 1 last month they take a drug and then use oral curcumin for 1 month, once a day after breakfast. Pain, burning sensation and size of the lesions assess before taking drug, and at the end of 1,2,4,8 weeks after treatment. Inclusion criteria are patients with oral lichen planus, who are volunteer and confirmed by histopathological evaluation. exclusion criteria is pregnant women, breast feeding women, patients who take corticosteroid, patients with peptic ulcer, gall-bladder stone, increased hepatic enzyme, and patients who take anti coagulation drugs, like warfarin. Treatment intervention is Consumption 80 mg oral curcumin capsule once a day for 1month. Primary outcome measure is pain and burning sensation of lesions, and secondary outcome measure is size of the lichen planus lesions.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201607032950N4
Registration date: 2016-10-29, 1395/08/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-10-29, 1395/08/08
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
research vice chancellorship of guilan univesity of medical science
Expected recruitment start date
2016-07-10, 1395/04/20
Expected recruitment end date
2016-09-10, 1395/06/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of oral curcumin on the size, pain and burning sensation of oral lichen planus lesions
Public title
Effect of oral curcumin on the size, pain and burning sensation of oral lichen planus lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients with oral lichen planus(confirmed by clinical examination, biopsy and histopathological evaluation) exclusion criteria: pregnant woman, breast feeding woman, patients who take corticosteroid, patients with peptic ulcer, gall-bladder stone, increased hepatic enzyme, and patients who take anti coagulation drug, like warfarin.
Age
From 20 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 13
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
single blind

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
ethics committee of guilan university of medical science
Street address
opposite of sepah bank, western shahid beheshti blv, rasht
City
rasht
Postal code
Approval date
2016-06-14, 1395/03/25
Ethics committee reference number
IR.GUMS.REC.1395.90

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
pain and burning sensation
Timepoint
before using drug and 1,2,4,8 after using drug
Method of measurement
use of visual analogue scale(VAS)

Secondary outcomes

1

Description
Size of the lichen planus lesions
Timepoint
Before treatment and 1,2,4,8 week after treatment
Method of measurement
tongprasom scale(0-5)

Intervention groups

1

Description
Consumption 80 mg oral curcumin capsule once a day for 1 month
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
dental school, guilan university of medical science
Full name of responsible person
Dr Seyad Javad Kia
Street address
pardis, imam str, rasht
City
rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
vice chancellor for research, guilan university of medical science
Full name of responsible person
Dr Rasool Tabari
Street address
opposite of sepah bank, western shahid beheshti blv, rasht
City
rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research, guilan university of medical science
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
Name of organization / entity
Dental school of guilan university of medical science
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant professor
Other areas of specialty/work
Street address
Pardis, emam ave
City
rasht
Postal code
Phone
+98 13 3323 7877
Fax
Email
djavadkia@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Dental school of guilan university of medical science
Full name of responsible person
Dr Seyed Javad Kia
Position
Assistant professor
Other areas of specialty/work
Street address
Pardis, emam ave
City
rasht
Postal code
Phone
+98 13 3323 7877
Fax
Email
djavadkia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Dental school of guilan university of medical science
Full name of responsible person
Dr Seyed Javd Kia
Position
Assistant proffessor
Other areas of specialty/work
Street address
Pardis, emam ave
City
rasht
Postal code
Phone
+98 13 3323 7877
Fax
Email
djavadkia@yahoo.com
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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