CTRI/2025/07/091836尚未招募不适用
RANDOMIZED OPEN LABELED CONTROLLED CLINICAL STUDY OF EFFICACY OF HARIDRADI TAILA MALAHAR PRATISARAN IN VATAJA PITTAJA MUKHPAKA WITH SPECIAL REFERENCE TO ORAL SUBMUCOUS FIBROSIS
Dr Pratibha Kondibarao Waghmare1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年8月11日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in mouth opening
研究概览
简要总结
Oral submucous fibrosis is a Premalignant condition
Satisfactory treatment is unavailable
Trial drug is Haridradi Taila Malahar and Control drug is Daruharidra Rasakriya these Ayurvedic medicines to be locally used as a Pratisaran for Oral submucous fibrosis
Both experimental and control groups are studied respectively
Observation and conclusions are drawn from statistical test for significance
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
- •Patient Selected As Per Diagnostic Criteria Of Oral Submucous Fibrosis.
排除标准
- •Patients Age Below 18 Years And Above 60 Years Suffering From Severe Trismus Interincisal distance of less than 0.5cm Other Inflammatory Conditions of Oral Cavity Such as Candidiasis Herpes stomatitis Oral lichen planus Diphtheria Congenital Maxillofacial deformities Suspected or Diagnosed malignancy Temporomandibular joint disorders Other systemic disease which may cause oral lesion such as TB Uncontrolled diabetes mellitus Severe anemia less than 7 gm per dl Patient suffering from Erythroplakia Patients on immunosuppressant therapy Acute infections or febrile illness Patients not willing to give up habits of chewing gutka tobacco and betel nut.
结局指标
主要结局
Improvement in mouth opening
时间窗: Before Treatment 0 day | After Treatment 31 st day
次要结局
未报告次要终点
研究者
Dr Pratibha Kondibarao Waghmare
Government Ayurved College and Hospital Nanded
研究点 (1)
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