CTRI/2019/12/022426尚未招募2 期
An Open Label Two Arm Randomised Clinical Study to Evaluate the Safety and Efficacy of Cystone SF Liquid in diabetic subjects suffering from Chronic Urinary Tract Infections
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Subjects demonstrating percentage improvement in the terms of efficacy parameters such as laboratory and clinical parameters.
研究概览
简要总结
This is an open label single arm clinicalstudy. Initially, subjects will be initiated for the informed consent processand then screening will be carried out for eligibility check.Subjects will bescreened to have 42 eligible subjects who will receive Cystone-SF liquid at adose of 10 ml twice daily for a period of 14 days. The whole study treatment isfor 14 days with follow up visit at day 1, 7 and 14. This study is divided intoScreening period, Active Treatment period and End of Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult male and female subjects aged more than or equal too 18 years presenting atleast two of the following UTI symptoms like urgency, dysuria, frequency of micturition (nos), suprapubic pain, haematuria, burning micturition, fever, flank pain, chills, nausea and emesis.
- •Known diabetic subjects with RBS less than or equal to 160 mg/dL.
- •UTI as diagnosed by urine culture more than 105 CFU/mL Urine routine microscopy suggestive of increase or normal number of pus cells (white blood cells) per cubic millimetre Subjects willing to sign informed consent and follow the study procedure.
- •Subjects who has not participated in any similar kind of clinical study in the last one month.
排除标准
- •History of neurogenic bladder, pelvic irradiation or chemical cystitis, Presence of urethral, pelvic, or rectal carcinoma, Benign or malignant bladder tumors, Tuberculous cystitis, urinary schistosomiasis.
- •Subjects with cardiac, neurological, renal or hepatic dysfunction.
- •Pregnant &breast-feeding women.
- •Significant medical problems such as uncontrolled hypertension / congestive heart failure or any other medication condition History of ongoing, chronic or recurrent infectious disease / lymphoproliferative disease or history of malignancy of any organ system within the past 5 years.
- •History of Alcohol or smoking abuse.
- •Patients unwilling to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
Subjects demonstrating percentage improvement in the terms of efficacy parameters such as laboratory and clinical parameters.
时间窗: The subject will be assessed clinically at day 7±3 days and at day 14±3 days (End of Study).
次要结局
- Percentage of individuals symptoms free by day 7 (Table 1)(Percentage of individuals symptoms free by day 14 (Table 1))
研究者
研究点 (1)
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