A Clinical Study to Evaluate the Efficacy and Safety of Cystone GNX tablet in UTI
- Conditions
- Health Condition 1: N390- Urinary tract infection, site notspecified
- Registration Number
- CTRI/2019/10/021789
- Lead Sponsor
- The Himalaya Drug Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Adult male and female subjects aged >=18 to <= 65 years presenting atleast two of the following UTI symptoms as described in table1
Three or more episodes of recurrent UTI in the past 12 months.
UTI as diagnosed by urine culture more than 105 CFU/mL
Subjects willing to sign informed consent and follow the study procedure.
Subjects who has not participated in any similar kind of clinical study in the last one month.
History of neurogenic bladder, pelvic irradiation or chemical cystitis, presence of urethral, pelvic, or rectal carcinoma, benign or malignant bladder tumors, tuberculous cystitis.
Kidney Infection
Pre-existing urolithiasis condition
Pre-existing systemic disease: cardiac, neurological, renal or hepatic dysfunction.
Antibacterial drug therapy for UTI during the previous 72 hours
Patients with suspected or confirmed prostatitis
Patients with renal transplantation or ileal loops
History of urinary tract structural abnormalities.
Any recent history of trauma to the pelvis or urinary tract.
Pregnant & breast-feeding women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjects demonstrating percentage improvement in the terms of efficacy parameters such as laboratory and clinical parameters from baseline to end of study.Timepoint: The subject will be assessed clinically at day 1, day 14 plus or minus 2 days and at day 28 plus or minus 2 days (End of Study).
- Secondary Outcome Measures
Name Time Method Safety evaluation through Incidence of adverse events during the study period. <br/ ><br>Compliance of the subject to the study medication <br/ ><br>Timepoint: The subject will be assessed clinically at day 1, day 14 plus or minus 2 days and at day 28 plus or minus 2 days (End of Study).