Evaluation of Comparative Efficacy of Mukharogahar Taila Gandusha (Oil Pulling) Versus Chlorhexidine Gargle in Tobacco Chewing Induced Stomatitis
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Reduction in redness, burning sensation, pain, number and size of ulcerations and recurrence rate.
研究概览
简要总结
The volunteers will be informed about study protocol. willing participants will be randomly selected as per computer generated table. the clinical research format will be prepared and validated.
before the study approval will be taken IEC, MGACRC ,salod Wardha and CTRI registration will be done. after selection each participant will be tested individually and selected according to selection criteria. They are divided into two groups. The trial is a randomized,open - label standard control equivalent clinical trial. it will include 15 days treatment period and follow up
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients having a history of chewing tobacco and its related products.
排除标准
- •1.Disease is most advanced with premalignant and malignant changes 2.Generalized fibromatosis 3.Chronic debilitating conditions such as uncontrolled DM, uncontrolled HT, HIV, etc.
- •4.Pregnant and lactating females.
- •5.Patients on Oral topical medications.
结局指标
主要结局
Reduction in redness, burning sensation, pain, number and size of ulcerations and recurrence rate.
时间窗: at baseline, 3rd day, 7th day, 15th day
次要结局
- ORAL INTAKE WILL BE INCREASED(15 DAYS)
研究者
Anamika jain
Mahatma Gandhi Ayurved College Hospital and Research Centre Salod Wardha