Evaluation of efficacy of moringa leaves extract in treatment of oral submucous fibrosis in comparison with standard treatment protocol - A randomized controlled trial.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Improvement in clinical parameters of Oral Submucous Fibrosis including burning sensation on visual analogue scale, mouth opening, tongue protrusion, and cheek flexibility.
研究概览
简要总结
This randomized controlled trial aims to evaluate the efficacy of Moringa oleifera leaves extract in various forms (tablet, powder, and gel) in the treatment of Oral Submucous Fibrosis (OSMF), compared with a standard treatment protocol. A total of 80 clinically diagnosed Stage II–III OSMF patients will be randomly allocated into four groups. Group I will receive Moringa tablets with standard drugs and gel, Group II will receive Moringa powder with standard drugs and gel, Group III will receive standard drugs with Moringa gel only, and Group IV will receive only standard treatment. Clinical parameters including burning sensation, mouth opening, tongue protrusion, and cheek flexibility will be assessed at baseline, 10th, 20th, and 30th day, followed by a 3-month follow-up. This study explores the potential role of Moringa as a natural therapeutic agent in the 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
- 15.00 Year(s) 至 35.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with clinically diagnosed Oral Submucous Fibrosis (OSMF) classified as Stage II-III (based on classification of Khanna and Andrade – 1995) 2.Patients with known history of areca nut, gutkha, kharra, pan masala chewing.
- •3.Patients who are willing to participate in the study.
排除标准
- •1.Patients who have left the habit in the last 6 months or more.
- •2.Patients with OSMF Stage IV.
- •3.Patients with any systemic diseases.
- •4.Patients on any medications.
- •5.Patients with history of hypersensitivity to any drug or natural plants including moringa.
- •6.Patients who are already under the treatment of OSMF.
结局指标
主要结局
Improvement in clinical parameters of Oral Submucous Fibrosis including burning sensation on visual analogue scale, mouth opening, tongue protrusion, and cheek flexibility.
时间窗: baseline, day 10, day 20, day 30, day 60
次要结局
- Sustained improvement in clinical parameters during follow-up
研究者
Dr Tapasya Karemore
Ranjeet Deshmukh Dental College and Research Centre, Digdoh hills, Higna Road Nagpur