CTRI/2024/06/069062尚未招募2 期
Phase II Non-randomized clinical study on Akkaram (Apthous Stomatitis) with the evaluation of Siddha trial drug Vazhai poo nei (internal) in children.
Government Siddha Medical College1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年10月3日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of clinical symptoms (like blisters in mouth, pallor, ulceration)
研究概览
简要总结
This is a single Non-randomized open clinical trial to study the safety and efficacy of Siddha trial drug Vazhai poo nei (internal) in treating Akkaram(apthous stomatitis). The trial drug is to be given 1-2 grams twice a day for 7-14 days. Clinical trial is to be conducted after conducting pre-clinical study. The trial drug Vazhai poo nei has been mentioned in Pararasasekaram Bala Roga Nidhanam. During the trial study the related data will be recorded and documented. Post the completion of trial the data will be statistically analyzed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 3.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Ulceration in the oral cavity (up to Grade III of WHO oral mucositis scale) 2.Blisters in the mouth 3.Pallor 4.Fever.
排除标准
- •Traumatic ulcer
- •Chemical burns
- •Oral ulcer due to cancer
- •Grade IV ulcer (WHO oral mucositis scale)
- •Secondary syphilitic ulcer
- •Herpetic gingivostomatitis.
结局指标
主要结局
Reduction of clinical symptoms (like blisters in mouth, pallor, ulceration)
时间窗: 14 days
Comparation with WHO oral mucositis scale
时间窗: 14 days
次要结局
- It is assessed by comparing the safety parameters before & after treatment(10 days)
研究者
Dr Abirami R
Government Siddha Medical College Arumbakkam Chennai
研究点 (1)
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