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
- 2/3 期
- 状态
- 尚未招募
- 入组人数
- 40
- 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 two arm randomised clinical study. Initially,subjects will be initiated for the informed consent process and then screeningwill be carried out for eligibility check. Subjects will be screened andrandomized to 2 arms. Arm 1 subjects will receive standard care of treatmenttwice daily for a period of 14 days and Arm 2 subjects will receive standardcare of treatment + 10 ml of Cystone SF liquid twice daily for a period of 14days. Thewhole study treatment is for 14 days with follow up visit at day 7 and 14. This study is dividedinto Screening period, Active Treatment period and End of Study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 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 ≥18 to ≤ 65 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 controlled blood sugar levels (RBS between 130 to 150 mg/dL).
- •Three or more episodes of recurrent UTI in the past 12 months.
- •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.
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 whole study treatment is for 14 days with follow up visit at day 7 and 14.
次要结局
- Percentage of individuals symptoms free by day 7 (Table 1)(Percentage of individuals symptoms free by day 14 (Table 1))