Comparative Study of the Efficacy of Lycopene Versus Prednisolone in the Management of Oral Lichen Planus: A Randomized, Double Blind Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 28
- 主要终点
- Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
研究概览
简要总结
Oral lichen planus (OLP) is a common sub-acute, chronic inflammatory mucocutaneous disease.This study was evaluated the comparative efficacy of lycopene and prednisolone for the treatment of oral lichen planus. Half of participants (total number of participants was twenty eight) were received lycopene and the other half were received prednisolone.
详细描述
Prednisolone and lycopene were produced remission of lesions in oral lichen planus patients, but they do so by different mechanisms.
The main cause of oral lichen planus is still unknown. Some authors advocate the disease appears to be a result of T-cell-mediated autoimmune responses in oral epithelial tissues. But, recent study suggests that increased reactive oxygen species (ROS) and lipid peroxidation together with an imbalance in the antioxidant defense system may play a part in the generation of disease.
Lycopene exerts its antioxidant activity by physical and chemical quenching of free radicals and decreases free radicals-initiated oxidative reactions, particularly lipid peroxidation and DNA oxidative damage, thereby preventing tissue damage.
Prednisone have both anti-inflammatory and immunosuppressant effects.It suppresses the inflammatory response by limiting the recruitment of inflammatory cells and inhibiting synthesis of pro-inflammatory products such as prostaglandins (PGs), leukotrienes (LTs) and platelet activating factors (PAF) by indirectly inhibiting phospholipase A2 and negative regulating cyclooxygenase (COX-2).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject had symptomatic i.e. burning sensation and/or pain secondary to oral lichen planus.
- •Subject had clinically & histo-pathologically diagnosed as oral lichen planus.
- •Subject had not on any treatment for the same or treatment likely to modify their oral lichen planus (e.g. systemic steroids, antifungals, immunosuppressant's, anti-oxidant).
排除标准
- •Suffering from any systemic disease/s such as diabetes, hypertension, cardiovascular, respiratory system disease, renal dysfunction, liver disorders, malignancy, active peptic ulcer diseases, acute gastrointestinal diseases, anemia and glaucoma, etc.
- •Suffering from serious or recurrent infection, immunodeficiency or HIV.
- •Pregnant or breast feeding (including women who wish to be pregnant during the study period).
- •Any other mucosal diseases or any other skin diseases which might be associated with oral lesions.
- •On any drug therapy which might be causes lichen planus like lesions.
- •Known allergy or contraindication to study medications.
研究组 & 干预措施
lycopene group
Lycopene- 4 mg capsule by mouth single dose per day for 2 months
干预措施: lycopene (Drug)
Prednisolone group
Prednisolone- 40 mg capsule by mouth single dose per day for 2 months
干预措施: Prednisolone (Drug)
结局指标
主要结局
Change in Severity of Lesions(Degree of Reticular, Erythematous and Ulceration) by Using Piboonniyom REU Severity Score
时间窗: 8 weeks minus baseline
Reticular: score 0= no white striations; score 1= white striations. Erythematous: score 0= no lesion; score 1= lesion \<1 cm2; score 2: lesion 1-3 cm2; score 3= lesion \>3 cm2. Ulceration: score 0= no lesion; score 1= lesion \<1 cm2; score 2= lesion 1-3 cm2; score 3= lesion \>3 cm2. Total weighted score was derived by sum total scores of each lesion and multiplication with weighted score 1.5 \& 2.0 in total erythematous and total ulceration scores as ΣR + ΣE × 1.5 + ΣU × 2.0.Total weighted score was dependent on the number of lesions of each participant which was not the same across participants. Higher value of the total score represent worse outcome \& zero value represent no lesion.
次要结局
- Burning Sensation or Pain by Using NRS (Numerical Rating Scale)(8 weeks minus baseline)
研究者
Dr. Ramayan Prasad Kushwaha
assistant professor
B.P. Koirala Institute of Health Sciences