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A Clinical Study to Evaluate the Efficacy and Safety of Cystone GNX tablet in UTI

An Open label, Two Arm, Randomized, Comparative Clinical Study to Evaluate the Efficacy and Safety of Cystone GNX tablet in chronic and recurrent UTI - Cys_GNX

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2019/10/021789
Enrollment
40
Registered
2019-10-24
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: N390- Urinary tract infection, site notspecified

Interventions

Intervention1: Cystone GNX tablets: This is an open label, two arm, randomized, comparative clinical study. Initially, subjects will be initiated for the informed consent process and then screening wi

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult male and female subjects aged >=18 to 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Safety evaluation through Incidence of adverse events during the study period. Compliance of the subject to the study medication 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).

Countries

India

Contacts

Public ContactDr Palaniyamma

The Himalaya Drug Company

dr.palani@himalayawellness.com

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026