Evaluation of efficacy of Moringa leaves extract in treatment of Oral Submucous Fibrosis in comparison with standard treatment protocol – A Randomised Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility)
研究概览
简要总结
This pilot study aims to assess the efficacy of Moringa oleifera leaf extract in different forms (tablet, powder, and 4% gel) in the management of Oral Submucous Fibrosis (OSMF). A total of 30 clinically diagnosed patients will be randomly divided into three groups and treated for 30 days. Group I will receive Moringa tablets + SM-FIBRO + Moringa gel, Group II will receive Moringa powder + SM-FIBRO + Moringa gel, and Group III (control) will receive SM-FIBRO + Turbocort gel. Clinical improvements in burning sensation, mouth opening, tongue protrusion, and cheek flexibility will be evaluated at baseline, Day 10, Day 20, and Day 30, followed by a 1-month follow-up.
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
- 15.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed OSMF Stage I to III by Khanna and Andrade classification
- •History of areca nut, gutkha, kharra, pan masala chewing
- •Willing to participate and give informed consent.
排除标准
- •Habit cessation in the last 6 months
- •Stage IV OSMF
- •Systemic illness or medications
- •Allergy to Moringa or herbal drugs
- •Already undergoing treatment for OSMF.
结局指标
主要结局
Change in clinical parameters (burning sensation, mouth opening, tongue protrusion, cheek flexibility)
时间窗: from baseline to Day 30
次要结局
- Sustained improvement in symptoms at 1-month follow-up after treatment completion
研究者
Dr Tapasya Karemore
Ranjeet Deshmukh Dental College and Research centre, Digdoh hills, Higna road, NAGPUR