Innovative Formulations of Curcumin & Its Comparative Efficacy in Management of Oral Submucous Fibrosis.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Burning sensation and pain
研究概览
简要总结
The purpose of the study is to determine whether the formulations of curcumin will effect the clinical signs and symptoms and histopathological features in patients with clinical stage 2 oral submucous fibrosis (OSMF).
详细描述
200 clinical stage 2 OSMF patients selected randomly by simple random technique with clinically & histopathologically confirmed diagnosis are divided into 4 groups with 50 patients each.
In Group 1 patients are given 10% of curcumin mucoadhesive gel and are instructed to use it topically twice daily making it a daily dose of 1gm.
In Group 2 patients are given 500mg of curcumin capsules and are instructed to take 2 capsules twice daily making a daily dose of 1gm.
In Group 3 patients will be given 5% of curcumin mucoadhesive gel and will be instructed to use it topically twice daily & 250mg of curcumin capsules to be taken twice daily making it a daily dose of 1gm.
Group 4 is considered as control group and provided with formulations without the active drug.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
single blinded
入排标准
- 年龄范围
- 14 Years 至 45 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •200 clinical stage 2 OSMF patients
排除标准
- •Clinical stage 1 & 3 OSMF patients, oromucosal disorders with clinical features same as OSMF, patients who are under treatment, clinically diagnosed cases not ready for incisional biopsy, patients suffering from medically compromised conditions.
研究组 & 干预措施
10%Curcumin mucoadhesive gel
Drug: Curcumin arm Curcumin10% mucoadhesive gel
Group 1 patients:
Drug : 10% curcumin mucoadhesive gel usage : Topical application Frequency : Twice daily Duration : 6 months
干预措施: 10% Curcumin mucoadhesive gel (Drug)
Curcumin capsules 500mg
Group 2 patients:
Drug : curcumin 500 mg capsules usage : oral intake Frequency : Twice daily Duration : 6 months
干预措施: Curcumin capsules 500mg (Drug)
5% Curcumin gel+Curcumin capsules 250mg
Group 3 patients:
Drug: 5% Curcumin mucoadhesive gel & Curcumin capsules 250mg usage : Topical application and oral intake Frequency : Twice daily Duration : 6 months
干预措施: 5% curcumin mucoadhesive gel + Curcumin capsules 250 mg (Drug)
Placebo capsules
Group 4 patients Drug: Placebo capsules usage : oral intake Frequency : Twice daily Duration : 6 months
干预措施: Placebo capsule (Drug)
结局指标
主要结局
Burning sensation and pain
时间窗: 6 months for each patient
Visual Analogue Scale
次要结局
- Interincisal distance, tongue protrusion and cheek flexibility(6 months for each patient)
研究者
Syeda Arshiya Ara
Professor & Research scholar
H.K.E.S's S.Nijalingappa Institute of Dental Science and Research