跳至主要内容
临床试验/CTRI/2018/08/015563
CTRI/2018/08/015563已完成3 期

Evaluation of the effectiveness of neem extracts mouthwash as an adjuvant therapeutic modality in the management of oral lichen planus

Dr Ashita Kalaskar1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2018年9月17日最近更新:

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
45
试验地点
1
主要终点
Burning sensation will be evaluated by visual analog scale.

研究概览

简要总结

Lichen planus is a chronic mucocutaneous disease with variable etiologies. As there is no established cure variable treatment modalities are available most of which provide symptomatic relief only to recur later. Neem has been considered wonder drug exhibiting various properties like antiinflammatory, immnomodulating, antifungal etc. hence this study is planned to evaluate the effectiveness of neem in oral lichen planus patients.

研究设计

研究类型
Interventional
分配方式
Permuted block randomization, variable
盲法
Participant and Investigator Blinded

入排标准

年龄范围
16.00 Year(s) 至 70.00 Year(s)(—)
性别
All

入选标准

  • 1.Symptomatic Patients with any clinical types and manifestations of OLP and those confirmed histopathologically will be included in the study.
  • 2.Patients who have discontinued previous treatment for OLP for last six months.

排除标准

  • 1.Patients younger than 16 years old.
  • 2.Patients with skin lesions.
  • 3.Patients with non symptomatic OLP lesions 4.Patients with lesions showing malignant or dysplasic changes.
  • 5.Patients undergoing any other treatment for oral lichen planus.
  • Pregnant and nursing woman.
  • Patients having systemic problems or under any medications for the same.
  • Patients having habit of chewing tobacco and betelnut or smoking.

结局指标

主要结局

Burning sensation will be evaluated by visual analog scale.

时间窗: Burning sensation and | The severity of lesions on each side will be evaluated on 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month, 3rd month.

The severity of lesions on each side will be evaluated by Thongprasom criteria.

时间窗: Burning sensation and | The severity of lesions on each side will be evaluated on 1st day, 3rd day, 7th day, 2nd week, 3rd week, 4th week, 2nd month, 3rd month.

次要结局

  • Acceptability of neem mouthwash.(Total duration required to decrease the symptoms.)

研究者

发起方
Dr Ashita Kalaskar
申办方类型
Other [self sponsor]

研究点 (1)

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