CTRI/2025/07/091750尚未招募Phase 3 4
Randomized Controlled clinical study of MARCEL poly herbal oral rinse in management of Oral Sub Mucous Fibrosis.
Jansuta Pharmaceuticals1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年8月4日最近更新:
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Improvement in inter incisional distance
研究概览
简要总结
Oral Sub Mucous Fibrosis is a common chronic stomatitis leading to trismus
It may lead to leukoplakia erythroplakia and malignant changes
Satisfactory treatment is not available
MARCEL is poly herbal medicine to be used locally as oral rinse in diluted form
Drug is FDA approved and clinical trials are already done
Control drug Irimedadi oil is an Ayurvedic medicine for local use for chronic stomatitis
Multicentric controlled clinical trial is being conducted
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of Oral Sub Mucous fibrosis.
排除标准
- •Extensive fibrosis with severe trismus within inter incisal distance less than 10 mm Disease is most advanced with premalignant and malignant changes Generalized fibromatosis Oral manifestations of scleroderma Oral lichen plants Pale Oral mucosa of anaemia mimicking blanching Chronic debilitating conditions such as TB HIV Patient not willing to give up addiction habits of Gutka pan masala tobacco etc.
结局指标
主要结局
Improvement in inter incisional distance
时间窗: Before Treatment 0 day | After treatment 60 th day
次要结局
未报告次要终点
研究者
Dr Nisar Ali Khan
Govt Ayurved College and Hospital Nanded
研究点 (1)
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