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
试验速览
- 阶段
- 1 期
- 入组人数
- 40
- 主要终点
- Pain intensity
研究概览
简要总结
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).
详细描述
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Outcome assessor (CS) and statistician
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients who will be clinically diagnosed as having atrophic &/or erosive oral lichen planus.
- •Patients with controlled diabetes and/or controlled hypertension will be included in the study.
- •Patients with no history of taking corticosteroids for the last 6 months
- •Patients who agrees to take medication.
排除标准
- •Pregnant and lactating ladies.
- •Patients with history of topical steroids during last 2 months & systemic steroids during last 6 months.
- •Patients with recent dental filling associated with the lesion or associated with recent drug administration.
- •Patient with uncontrolled diabetes, uncontrolled hypertension, or those with positive HCV ab or HBs Ag.
研究组 & 干预措施
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).
干预措施: Turmeric paste (Drug)
Triamcenolone in orabase
Triamcenolone + na ploycarboxylate
干预措施: Triamcinolone (Drug)
结局指标
主要结局
Pain intensity
时间窗: 4 weeks
measured by Visual Analog Scale (VAS) 0 = no pain 10= severe pain 0= no pain 10= pain severe pain
次要结局
- clinical sign score(Baseline , 2nd week and 4th week)
- IL-33 level in saliva(base line and 4th week)
研究者
Mohamed salah abd-elhameed
principal investigator
Cairo University