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临床试验/CTRI/2017/02/007784
CTRI/2017/02/007784已完成4 期

An Open Labelled , Interventional, Single Centric Clinical Study To Assess the Therapeutic Efficacy & Safety of Stonvil Capsules for the treatment of Recurrent Urinary Tract Infections associated with Renal Calculi.

S G Phyto Pharma Pvt Ltd0 个研究点目标入组 30 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
30

研究概览

简要总结

暂无简介。

研究设计

研究类型
Pms

入排标准

入选标准

  • 1.Male and Female subjects of age 18 years and above.
  • 2.Subjects reported with Renal Calculi, while investigatorâ??s assessment.
  • 3.History of recurrent Urinary Tract Infections (3 or more confirmed UTIâ??s in the past 6 â?? 12 Months).
  • 4.Subjects with Urinary Tract Infections, as confirmed by Urinalysis.
  • 5.Subjects with symptoms of Urinary Tract Infections like Cloudy or Bloody Urine, which may have foul or strong odor, Painful or burning micturition, Pressure or Cramping in lower abdomen or back, Strong need to urinate often, even right after the bladder has been emptied etc.
  • 6.Subjects who are not taking any other medication for Urinary Tract Infection.
  • 7.Be informed of the nature of the study and will give written informed consent.
  • 8.Able to communicate well with the investigator, to understand and comply with the requirements of the study.

排除标准

  • 1.Complicated cases of Renal Calculi requiring surgery.
  • 2.Subjects taking herbal supplements for Renal Calculi or Urinary Tract Infections within previous 30 days.
  • 3.Evidence of significant, uncontrolled concomitant disease which in the investigatorâ??s opinion would preclude subject participation.
  • 4.Females of childbearing age without adequate contraception.
  • 5.Use of disallowed concomitant medications.
  • 6.Any disease or condition which might compromise the hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system.
  • 7.Use of any recreational drugs or a history of drug addiction and chronic alcoholics.
  • 8.Patient not willing to sign informed consent.

研究者

发起方
S G Phyto Pharma Pvt Ltd

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