CTRI/2018/02/011939招募中不适用
A PROSPECTIVE, COMPARATIVE, RANDOMIZED STUDY TO ASSESS THE EFFICACY AND SAFETY OF SNEC30 (CURCUMA LONGA) IN THE TREATMENT OF ORAL SUBMUCOSAL FIBROSIS
Arbro Pharmaceuticals Pvt Ltd1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2017年11月27日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in burning sensation.
研究概览
简要总结
The aim of the present study is to conduct study to evaluate its utility in oral submucosal fibrosis where there is a reasonable probability ofcurcuminoids being useful / curative.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patient or his legally accepted representative is willing to give informed consent.
- •2.Patient is in the age range of 18-65 yrs.
- •3.Patient clinically diagnosed with OSF (diagnosed on the basis of reduction in interincisal distance on maximum mouth opening and palpable fibrous bands involving oral mucosa).
- •4.Patient is willing to discontinue the use of tobacco in any form or areca 1-month prior to the commencement of the treatment.
排除标准
- 未提供
结局指标
主要结局
Reduction in burning sensation.
时间窗: reduction in burning sensation and mouth opening will be checked at enrollment day , day 28, day 56 and day 84.
Improvement in mouth opening.
时间窗: reduction in burning sensation and mouth opening will be checked at enrollment day , day 28, day 56 and day 84.
次要结局
- Safety and tolerability of the drug will be evaluated on the basis of occurrence / non-occurrence, type, frequency and duration of drug-related adverse reactions(Safety and tolerability of the drug will be evaluated throughout the study.)
研究者
研究点 (1)
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