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临床试验/CTRI/2025/11/097910
CTRI/2025/11/097910尚未招募2 期

A Randomized Controlled Clinical Study to Evaluate the Efficacy of Sharbat -e- Bazoori Moatadil Versus Nitrofurantoin in Pediatric Urinary Tract Infection.

State Unani Medical College and Hospital1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年12月19日最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方
入组人数
50
试验地点
1

研究概览

简要总结

Urinary tract infections UTIs are one of the most common bacterial infections in childhood  affecting approximately 7.8percent of children

There are different clinical symptoms of UTI such as cystitis pyelonephritis  asymptomatic bacteriuria  chronic and recurrent UTIs  of which cystitis is the most frequent presentation affecting the urinary bladder  If prompt treatment is not received the bacteria may continue to grow in the urinary tract and cause a kidney infection Between 75 and 95 percent of all cases of uncomplicated UTI are community acquired and are brought on by uropathogenic E. coli UPEC and Klebsiella spp. The most prevalent uropathogen was found to be E. coli  followed by K. pneumoniae

Symptoms are classified by severity Minor pyrexia adequate fluid intake minor dehydration and good treatment compliance are characteristics of mild UTIs Lower UTIs represent the majority of mild UTIs

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
3.00 Year(s) 至 18.00 Year(s)(—)
性别
All

入选标准

  • Patients of both genders aged 3 to 18 years diagnosed with uncomplicated UTI.
  • Signs and symptoms consistent with UTI (e.g., fever, dysuria, frequency, suprapubic pain,) plus a positive urine analysis (pyuria equal or more than 5 WBC per HPF or positive leukocyte esterase per nitrite) or positive urine culture (more than 105 CFU per mL for midstream clean-catch or per local diagnostic cut-offs).
  • First episode or non-complicated recurrent UTI (equal or less than 2 episodes in past 12 months).
  • Patient’s guardian or parents willing to sign the informed consent form and follow the study protocol.

排除标准

  • Complicated UTI ( e.g., pyelonephritis with systemic toxicity, urosepsis, prostatitis etc.) Structural or functional urinary tract abnormality.
  • Recent antibiotic used ( Use of systemic antibiotics active against urinary pathogens within 48–72 hours prior to screening).
  • Exclude culture sensitive proven Nitrofurantoin resistant cases.
  • Patient is unsure about attending schedule regularly.

研究者

发起方
State Unani Medical College and Hospital
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Mo Azahar

State Unani Medical College and Hospital

研究点 (1)

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