A Clinical Study To Assess the Efficacy & Safety of Stonvil Capsules (Ayurvedic Formulation)for the treatment of Recurrent Urinary Tract Infections associated with Renal Calculi.
- Conditions
- Health Condition 1: null- Recurrent Urinary Tract Infections associated with Renal Calculi
- Registration Number
- CTRI/2017/02/007784
- Lead Sponsor
- S G Phyto Pharma Pvt Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 30
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.
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.
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Primary Outcome: <br/ ><br>Reduction in Symptoms of Recurrent Urinary Tract Infection as compared to Baseline Visit.Timepoint: 20 Days
- Secondary Outcome Measures
Name Time Method Secondary Outcomes: <br/ ><br>Assessment of Adverse Events associated with the treatment. <br/ ><br>Timepoint: 20 Days