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

Phase 2

Not yet recruiting

• Conditions: Urinary tract infection, site notspecified,

• Registration Number: CTRI/2019/10/021789
• Lead Sponsor: The Himalaya Drug Company

Brief Summary

This is an open label,two arm, randomized, comparative clinical study. Initially, subjects will beinitiated for the informed consent process and then screening will be carriedout for eligibility and subjects will be screened to have 80 eligible subjects.As per randomization, the subjects will receive either Cystone GNX tablet at adose of 1 tablet twice daily for a period of 28 days OR Cystone tablet at a doseof 1 tablet twice daily for a period of 28 days. The whole study treatment isfor 28 days with visit at day 1, 14 and 28.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-11
• Last Update Posted: 2019-10-23

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• 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.

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.

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.	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.	Compliance of the subject to the study medication

Trial Locations

Locations (1)

Jupiter Surgical Speciality Centre; 🇮🇳 Chennai, TAMIL NADU, India

Jupiter Surgical Speciality Centre

🇮🇳Chennai, TAMIL NADU, India

Dr T Srinivasan

Principal investigator

9442217211

srinivasan.euro@gmail.com