Therapeutic potential of Natural polyphenol-Resveratrol in Premalignant oral lesions-A Randomised Controlled Study”
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- • Change in lesion size and clinical appearance.
研究概览
简要总结
Title of the Study/Project : Therapeutic potential of resveratrol in PMD, a randomised
Resveratrol , a natural polyphenol , exhibits anti-inflammatory , antioxidant and
wound healing properties by modulating cytokines and oxidative stress .
Preclinical studies support its role in enhancing tissue repair but clinical evidence i
oral surgery is limited .
clinical evidence supporting the use of Resveratrol in the treatment of oral
premalignant lesions remains limited, with few well-designed randomized controlle
trials evaluating its therapeutic potential.
This study aims to fill this gap by rigorously assessing the clinical and
histopathological effects of Resveratrol in patients with oral premalignant lesions
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- Male
入选标准
- •1 Adults aged 18–70 years 2 Histologically confirmed OPLs (e.g.leukoplakia, oral epithelial dysplasia) 3 Lesion size should be more than or equal to 1cm 4 No prior treatment for the current lesion.
- •5 Willingness to comply with study procedures and provide informed consent.
排除标准
- •1 Malignant oral lesions 2 Severe systemic conditions or immunocompromised status 3 Pregnancy or lactation 4 Known hypersensitivity to resveratrol 5 Concurrent use of other chemopreventive agents.
结局指标
主要结局
• Change in lesion size and clinical appearance.
时间窗: Duration of study - 12 months
• Histopathological assessment of dysplasia grade.
时间窗: Duration of study - 12 months
次要结局
- • Patient-reported pain & discomfort scores.(• Incidence of adverse events.)
研究者
Dr nitin bhagat
Manav rachna dental college