Phase II Non-Randomized Open Clinical Evaluation of siddha medicine Kandhaga Rasayanam for the management of Azhal Neer churukku (Urinary Tract Infection)
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
- It is mainly assessed by reduction in clinical signs and symptoms by UTI symptom assessment score and also assessed by urine culture when bacterial/fungal infection becomes negative after treatment
研究概览
简要总结
This is a phase II Non- Randomized open clinical trial to study the safety and efficacy of siddha medicine Kandhaga Rasayanam for Azhal Neerchurukku (Urinary tract Infection). The trial drug is given 1 to 2 gm twice a day for 15 days. Clinical trial is conducted after conducting the preclinical toxicity study. The Trial drug Kandhaga Rasayanam is mentioned in the book Siddha vaidhya thirattu. During the trial all the study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjrcts within 20-60 years, having symptoms such as, Frequency of Urination, Burning micturition, Dysuria, Lower abdominal pain, Low bach ache, Hematuria, patients with significant for bacteria in urine culture, patients having moderate to severe symptoms according to UTI symptom assessment scale.
排除标准
- •Pregnant women, History of Diabetes mellitus, History of sexually transmitted disease, History of Malignancy will be excluded.
结局指标
主要结局
It is mainly assessed by reduction in clinical signs and symptoms by UTI symptom assessment score and also assessed by urine culture when bacterial/fungal infection becomes negative after treatment
时间窗: 15 days
次要结局
- By comparing the clinical signs and symptoms and the urine culture before and after the treatment(15 days)