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IRCT20100101002950N5 IRCT 2019-02-09 Rasht University of Medical Sciences 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 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 2019-02-19 anticipated 56 Complete https://irct.ir/trial/36704 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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 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. 3 Oral Lichen Planus. Intervention 1: Intervention group: Consumption of 80 mg oral Curcumin capsule once a day for 1 month. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: data are shareable after making them unidentifiable. When: accessibility starts from 6 month after publish To whom: data will be accessible for researchers of universal and scientific institution. Conditions: they can use them with reference Where to obtain: dr seyed javad kia djavadkia@yahoo.com How to obtain: after receiving the request, data will be send to applier during 1 month Comments:
public Dr Seyed Javad Kia
Pardis, Emam Ave
Rasht Iran (Islamic Republic of) 41941-73773 +98 13 3323 7877 djavadkia@yahoo.com Rasht University of Medical Sciences scientific Dr Seyed Javad Kia
Pardis, Emam Ave
Rasht Iran (Islamic Republic of) 41941-73773 +98 13 3323 7877 djavadkia@yahoo.com Rasht University of Medical Sciences Iran (Islamic Republic of) Patients with Oral lichen planus(confirmed by clinical examination, biopsy and histopathological evaluation) no limit no limit Both 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 L43 Lichen planus Treatment - Drugs Treatment - Drugs Intervention group: Consumption of 80 mg oral Curcumin capsule once a day for 1 month 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 Severity of pain. Timepoint: Before treatment and 1,2,4 week after treatment. Method of measurement: Use of Visual Analogue Scale(VAS). Size of the Lichen planus lesions. Timepoint: Before treatment and 1,2,4 week after treatment. Method of measurement: Tongprasom scale(0-5). Rasht University of Medical Sciences Approved 2018-11-02 Ethics committee of Guilan University of Medical Sciences Opposite of Sepah bank, Western Shahid Beheshti Blv Rasht Guilan Iran (Islamic Republic of)