Efficacy of 200mg and 300mg Concentrates of Green Tea Polyphenols Using Buccal Tablets Versus Topical Application of Corticosteroids in Treatment of Patients With Symptomic Oral Lichen Planus Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- size of the lesion
研究概览
简要总结
Is topical application of green tea polyphenols buccal tablet more effective in treatment of patients with symptomatic oral lichen planus in comparison with topical application of corticosteroids and what is the most effective concentration of polyphenols
详细描述
- Each patient was informed about the detailed procedure, and educated about benefits of the treatment, the known side effects and follow-up appointments needed. After that, each subject participating in the study signed an informed written consent form.
- Subjects were given freedom to leave the study at any time when they need to. Group A (Experimental group) 200 mg green tea
Where patients in this group will receive a buccal tablet containing 200 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
Preparation of buccal tablets : Mucoahesive buccal tablets is prepared by a direct compression procedure. Various batches are prepared by varying the chitosan:drug ratio to identify the most effective formulation. The mucoadhesive drug/polymer mixture is prepared by homogeneous mixing of the drug with chitosan , secondary polymer, and D-mannitol, in a glass mortar for 15 min. Then, Mg stearate will be added and mixed for 5 min .The mixture is compressed using a tablet machine (Type EK: O.Erweka apparatus, Frankfurt, Germany) using flat-tip punches and dies with 8-mm-diameter. Each tablet weighed 212 mg with a thickness of 3.1 mm.( Darwish and Elmeshad,2009)
Group B (Experimental group) 300 mg green tea
Where patients in this group will receive a buccal tablet containing 300 mg of green tea extract which adheres to the buccal mucosa slowly releasing the polyphenoles along around 8 hours 2 times aday for four weeks.
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)
入排标准
- 年龄范围
- 17 Years 至 80 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic lesions.
- •OLP lesions with the diagnosis confirmed both clinically and histopathologically.
- •Clinical score higher than
- •Disease duration of more than 2 months.
- •Absence of dysplasia in histological section
排除标准
- •Presence of any visible oral lesion other than OLP.
- •Pregnant or breast-feeding women,
- •Immuno-deficiency diseases.
- •Current malignancy or malignancy in history.
- •Concomitant treatment potentially effective on OLP within the previous 2 months such as antimalarial agents, retinoids, corticosteroids or immunosuppressive drugs.
- •Severe or recurrent infections.
- •Lichenoid reaction.
- •Patients presents with skin lesions which may require systemic corticosteroid therapy.
研究组 & 干预措施
green tea buccal tablet
buccal tablet 3 times aday
干预措施: green tea buccal tablet (Drug)
corticosteroids topical
topical steroids 3 times aday
干预措施: Corticosteroids Topical (Drug)
结局指标
主要结局
size of the lesion
时间窗: 12 weeks
the shape and the measurement of its size
次要结局
- visual analogue score(12 weeks)
研究者
Esraa Magdy
princible investigator EMagdy
Cairo University