CTRI/2026/02/103654尚未招募不适用
Comparison of efficacy of Lycopene and Xantinol Nicotinate in the management of patients with OSMF: A Randomized Clinical Trial
OTHER1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年2月28日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mouth opening(interincisinal distance)
研究概览
简要总结
| 1)Excessive |
| deposition of collagen fibers leads to occluded blood vessels which in turn |
| lead to hyper-coagulabilty of blood. Hyper coagulated blood acts as an |
| obstacle in the path of nutrients and therapeutic substances to reach the |
| affected tissues. |
2) This may be one of the prime reasons behind failure of drug treatment in OSMF
3) Xantinol nicotinate, a peripheral vasodilator when injected intralesionally may prove to be highly effective in the treatment of OSMF.
4) However, the numbers of reported randomized clinical trials are limited .
Also, lycopene and intralesionally Xantinol nicotinate has not been researched extensively in management of OSMF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of either gender aged between 18-45 years.
- •Consumption of areca nut and its products.
- •Exhibiting signs and symptoms of OSMF.
- •Patients with no history of any treatment for Oral submucous fibrosis in the past 6 months.
- •Patients willing to participate and ready for regular follow-ups.
- •Patients willing to quit habits.
排除标准
- •Patients with other mucosal disorders with clinical features same as oral submucous fibrosis.
- •Patients on anticoagulants.
- •Pregnant patients.
- •History of recent myocardial infarction, cerebrovascular accidents, severely compromised cardiac function, and caffeine or theophylline intolerance.
- •Patients hypersensitive to Xantinol nicotinate.
结局指标
主要结局
Mouth opening(interincisinal distance)
时间窗: 2 months (every 1 weeks follow up)
次要结局
- burning sensation (VAS score)(2 months(every 1 weeks follow up))
研究者
AMIT TIWARI
peoples college of dental sciences and research center bhopal
研究点 (1)
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