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IRCT20160420027501N2 IRCT 2019-11-23 Islamic Azad University Effect of curcumin on oral lichen planus Clinical trial of the effect of curcumin on treatment of oral lichen planus 2019-12-22 anticipated 28 Complete https://irct.ir/trial/41468 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly assigned to two groups of intervention and control using block randomization with block sizes of 4. Randomization will be done using the software randomization option in Excel. The randomization process is performed by the study methodology consultant and clinical researchers are not aware of the randomization process. In order to be able to divide the samples into 4 blocks, the sample size of each group is 14 persons. 3 Oral Lichen Planus. Intervention 1: Control group: Receives corticosteroid mouthwash (triamcinolone acetone 40mg in 1 ml with 19 cc distilled water, 5 cc each time) 3 times daily with antifungal mouthwash (20 drops of 100,000 IU oral suspension nystatin, 3 times/day) in addition to placebo capsules, once a day, after breakfast, for 4 weeks. Intervention 2: Intervention group: In the intervention group, in addition to the standard treatment similar to the control group, curcumin capsules manufactured by Sina Co. with brand name of "Sina curcumin" containing 80 mg nanocrystalline curcumin are used once a day after breakfast for 4 weeks. In both groups, the patient uses the mouthwash for 2 minutes and then spits out and avoids eating and drinking for up to 30 minutes thereafter. Yes - There is a plan to make this available What will be shared: IPD collected for the primary outcome measure only When: starting 6 months after publication To whom: Everybody Conditions: Everybody Where to obtain: Call Dr. Mandana Khatibi How to obtain: Send an email to m_khatibi@dentaliau.ac.ir and wait for response Comments:
public Nazanin Ghobadi
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 nazaninghobadi7@gmail.com Islamic Azad University scientific Dr. Mandana Khatibi
Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran
Tehran Iran (Islamic Republic of) 1946853314 +98 21 2256 4571 m_khatibi@dentaliau.ac.ir Islamic Azad University Iran (Islamic Republic of) Age 30-70 years Diagnosis of oral lichen planus with biopsy 30 years 70 years Both Corticosteroid therapy within two months before the study Pregnancy or lactation Hypertension, diabetes, hemorrhagic disorders Taking medications that cause lichenoid reactions Dysplasia lesions Skin lesions L43 Lichen plaus Placebo Treatment - Drugs Control group: Receives corticosteroid mouthwash (triamcinolone acetone 40mg in 1 ml with 19 cc distilled water, 5 cc each time) 3 times daily with antifungal mouthwash (20 drops of 100,000 IU oral suspension nystatin, 3 times/day) in addition to placebo capsules, once a day, after breakfast, for 4 weeks. Intervention group: In the intervention group, in addition to the standard treatment similar to the control group, curcumin capsules manufactured by Sina Co. with brand name of "Sina curcumin" containing 80 mg nanocrystalline curcumin are used once a day after breakfast for 4 weeks. In both groups, the patient uses the mouthwash for 2 minutes and then spits out and avoids eating and drinking for up to 30 minutes thereafter. Pain and Soreness. Timepoint: Before treatment and 2 , 4 weeks after treatment. Method of measurement: Asking from patients, based on visual analogue scale (VAS) and between 0-10. Size of the lesion. Timepoint: Before treatment and 2 , 4 weeks after treatment. Method of measurement: by the Michigan 'O' Probe in mm. Scoring and appearance of oral lichen planus lesions. Timepoint: Before treatment and 2 , 4 weeks after treatment. Method of measurement: Observation. Islamic Azad University Approved 2019-05-11 Ethics committee of Islamic Azad University of Medical Sciences, Tehran Tehran Azad University faculty of Dentistry, 10th Neyestan St, Pasdaran Ave, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)