An Open Clinical Trial To Evaluate The Effectiveness Of Gandhaga Mezhugu In The Management of Neerkiricharam (Urinary Tract Infection) - A Pilot Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Urine culture test negative for bacterial growth.
研究概览
简要总结
This is an Open labelled, Non randomized, Singlecentric clinical trial to evaluate the effectiveness of GandhagaMezhugu in the management of Neerkiricharam (UrinaryTract infections). Urinary tract infections (UTIs) are common infections thataffects any part of the urinary system, which includes the kidneys, bladder,ureters, and urethra. UTIs are typically caused by bacteria, with Escherichiacoli (E. coli) being the most common culprit . Every year, around 150 millionUTIs occur worldwide, leading to about $6 billion in healthcare spending. Theusual treatment includes using antibiotics carefully.
However, the growing issue of becomingresistant to antibiotics is causing concern. This resistance can result inlonger and more severe infections, increased healthcare costs, and a greaterrisk of complications. As antibiotic resistance continues to grow, researchersare exploring alternative treatment options to address UTIs effectively.Traditional herbal and mineral-based medicines have gained attention aspotential alternatives to antibiotics. These traditional remedies, derived fromplants, minerals, or other natural sources, have been used in various culturesfor centuries to treat infections and promote overall health.
Gandhaga Mezhugu,a herbo-mineral composite, has exhibited antibacterial properties againstprevalent pathogens responsible for urinary tract infections in preclinicalevaluations. This clinical investigation endeavors to systematically ascertainthe efficacy of Gandhaga Mezhugu, an established therapeuticapproach for multiple infection conditions. The study will be conducted in OPNo. 11/12, Department ofGunapadam, Ayothidoss Pandithar Hospital,National Institute of Siddha, Chenna. Patients will be screened and recruitedto the study based on the inclusion criteria. The sample size is 10 patientsand the study period is 6 months. The outcome is assessed based on the urineculture and decrease/absence of the clinical signs and symptoms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Presenting with the clinical signs and symptoms of Uncomplicated Urinary Tract infection 2.Patients with positive urine culture for bacterial growth 3.Patients willing to take urine routine, urine culture and radiological investigation.
排除标准
- •1.Patients presenting with signs and symptoms of complicated UTI (those arising in a setting of catheterization, instrumentation, urologic anatomic or functional abnormalities, stones, obstruction, immunosuppression, cancer, renal or hepatic disease) 2.Pregnant and lactating women 3.Known cases of Genitourinary tuberculosis,Diabetes Mellitus, Sexually transmitted diseases like HIV & Syphilis 4.Patient not willing to undergo urine routine and urine culture.
结局指标
主要结局
Urine culture test negative for bacterial growth.
时间窗: 14days
次要结局
- Assessment of absence or decreased severity of(clinical signs-symptoms after completion of the)