The Effect of Topical Curcumin Versus Topical Corticosteroid on Management of Oral Lichen Planus Patients
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|ClinicalTrials.gov Identifier: NCT03877679|
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Introduce a new anti-inflammatory and antioxidant paste preparation (curcumin paste) in the management of Oral lichen planus.
- Assess the efficacy of this preparation on pain, clinical parameter and the level of IL-33 in saliva.
- Compare the outcome of new preparation with the gold standard treatment (corticosteroids).
|Condition or disease||Intervention/treatment||Phase|
|Oral Lichen Planus||Drug: Triamcinolone Drug: Turmeric paste||Phase 1|
Two groups will be prepared then decision of which one take curcumin paste will be selected according to randomized numbers in a sequentially numbered, opaque, sealed envelope
1 group will take topical corticosteroid and 1 will take curcumin paste then IL-33 level in saliva will be measured at the base line and at the end of 4th week pain and clinical parameters will be measured at 2nd and 4th week
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Outcome assessor (CS) and statistician|
|Official Title:||The Effect of Topical Curcumin Versus Topical Corticosteroid on Pain, Clinical Parameters and Salivary Level of IL-33 in Oral Lichen Planus Patients: A Randomized Controlled Clinical Trial|
|Estimated Study Start Date :||May 1, 2019|
|Estimated Primary Completion Date :||May 1, 2020|
|Estimated Study Completion Date :||June 1, 2020|
Experimental: turmeric paste
Topical curcumin gel (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University traumeric extracted from Curcuma plant, it has anti-inflammatory, antioxidative and antineoplastic properties ((Nosratzehi et al., 2018), The curcumin is safe even in high doses, Since oxidative stress may play a role in pathophysiology of OLP, and by noting that OLP is a chronic inflammatory disease, the herbs which have both anti-inflammatory and antioxidant properties may efficiently control OLP (Kia et al., 2015).
Drug: Turmeric paste
Topical turmeric paste (a mixture of curcumin powder and vegetable glycerin base in a ratio of 1:8 by weight) Mix with 85ml carbapol gel (125ml H2O + 0.5g carbapol + triethanolamine 3 drops) prepared in the Faculty of pharmacy-Cairo University
Other Name: Curcumin
Active Comparator: Triamcenolone in orabase
Triamcenolone + na ploycarboxylate
Other Name: Triamcenolone in orabase
- Pain intensity [ Time Frame: 4 weeks ]measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
- clinical sign score [ Time Frame: Baseline , 2nd week and 4th week ]measured by Thongprasom from score 0 to 5 0= only white lesion 5=area of erosion more than 2 cm
- IL-33 level in saliva [ Time Frame: base line and 4th week ]by ELISA