A Clinico-microbiological study to isolate and identify Urinary Tract Infection (UTI) causing microbes in pregnancy and effects of Gokshur (Tribulus terrestris).
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 135
- 试验地点
- 1
- 主要终点
- Primary Outcome:
研究概览
简要总结
Urinary Tract Infection (UTI) is a common complication during pregnancy and can lead to serious maternal and fetal outcomes. UTI can be asymptomatic, with bacteria present in urine without symptoms, or symptomatic, characterized by symptoms like dysuria, frequent urination, suprapubic pain, and fever. Infections of the upper urinary tract, such as pyelonephritis, can result in more severe complications like preterm labor, anemia, and even maternal death. Risk factors for UTI in pregnancy include physiological changes, a history of UTI, advanced maternal age, and poor hygiene. Common pathogens responsible for UTI include *Escherichia coli*, *Klebsiella*, *Proteus mirabilis*, and *Enterococcus*. Prevalence rates of UTI during pregnancy range from 4-25%, and treatment typically involves a short course of antibiotics. However, antibiotics such as Nitrofurantoin and Trimethoprim-Sulfamethoxazole are avoided in the first trimester due to potential fetal risks. Additionally, the overuse of antibiotics has led to drug resistance, posing a challenge in treating UTI.
To address these challenges, alternative treatments like the use of Gokshura (*Tribulus terrestris*), a traditional Ayurvedic herb with antimicrobial and diuretic properties, are being explored. Gokshura is known for balancing doshas and aiding in the treatment of UTI symptoms without the side effects associated with antibiotics. The study aims to evaluate the efficacy of Gokshura in treating UTI during pregnancy, comparing its effects alone and in combination with conventional antibiotics. Additionally, it seeks to isolate and identify the bacteria responsible for UTI in pregnant women and determine the minimum inhibitory concentration (MIC) of Gokshura and antibiotics against these pathogens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)(—)
- 性别
- Female
入选标准
- •Pregnant women suspected with UTI, patients having presence of high number of RBCs, pus cells, epithelial cells, bacteria; and patient having bacterial growth on urine culture.
排除标准
- •Age below 18 years or above 45 years; Patients on antibiotic therapy; Diabetic patients; Viral marker reactive patients; and those not consenting for the study.
结局指标
主要结局
Primary Outcome:
时间窗: At the end of 14 days
Complete Response: Disc size less than 7mm.
时间窗: At the end of 14 days
Partial Response: Disc size 7 to 14mm.
时间窗: At the end of 14 days
No Response: Disc size greater than 14mm.
时间窗: At the end of 14 days
次要结局
- Secondary Outcome:(Complete Response: No clinical signs or symptoms)
研究者
Alok Pandey
BANARAS HINDU UNIVERSITY
