CTRI/2016/05/006973招募中2 期
Further study on ayurvedic management of oral submucous fibrosis(osmf)
INSTITUTE FOR POST GRADUATION TEACHING AND RESEARCH IN AYURVEDA1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年2月20日最近更新:
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Increase in interincisal distance
研究概览
简要总结
OralSubmucous Fibrosis (OSMF) is a chronic debilitating disease of the oral cavity resultingfrom habits like smoking, alcoholism, mawa, pan-masala, gutkha, tobacco, betelnut and betel quid chewing.
In Group A Firstof all Erandbhristha Haritaki will be given for Kosthasuddhi for3 days followed by Shadabindu Taila Shodhan Nasya for 5 days.After that following treatment will be given simultaneously for 45 days.
· Madhu-pippalyadi Yoga forPratisarana.
· NishadiTaila for Kavala.
RasayanaYogaorally
In Group B Physiotherapy and Antioxidantswith multivitamin capsules becosules-Z will be given.
研究设计
- 研究类型
- Interventional
- 分配方式
- Other
- 盲法
- Open Label
入排标准
- 年龄范围
- 16.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •The patients having clinical signs and symptoms of OSMF-blanching and stiffness of oral mucosa, trismus, burning sensation in mouth, intolerance to eating hot and spicy foods, repeated vesicular eruption and ulceration on the bucal mucosa, palate, and pillars; reduced mobility of soft palate and tongue, loss of gustatory sensation etc.
- •Interincisal distance between 15mm-40mm.
排除标准
- •Extensive fibrosis of all the oral mucosa, severe trismus with an interincisal distance of less than 15mm.
- •Disease is most advanced with premalignant and malignant changes.
- •Generalized fibromatosis.
- •Oral manifestation of scleroderma.
- •Oral lichen planus.
- •Pale oral mucosa of anemia.
- •Chronic debilitating conditions like DM, HT, HIV etc.
- •Patients not willing to give up habits of gutkha, pan-masala, mawa, tobacco, betel quid or betel nut chewing.
结局指标
主要结局
Increase in interincisal distance
时间窗: 45 days
次要结局
- Relief from symptoms of oral submucous fibrosis(45 days)
研究者
研究点 (1)
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