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Evaluate the Efficacy of Cystone-SF Liquid in diabetic subjects suffering from Chronic UTI

Open Label Two Arm Randomised Clinical Study to Evaluate the Safety and Efficacy of Cystone SF Liquid in diabetic subjects suffering from Chronic Urinary Tract Infections

Status
Active, not recruiting
Phases
Phase 2Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/03/024271
Enrollment
40
Registered
2020-03-26
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 SF Liquid: Standard care of treatment + 10 ml of Cystone SF liquid twice daily for a period of 14 days. Control Intervention1: Standard care of treatment: Standard care of treat

Sponsors

The Himalaya Drug Company
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult male and female subjects aged >=18 to Known diabetic subjects with controlled blood sugar levels (RBS between 130 to 150 mg/dL). Three or more episodes of recurrent UTI in the past 12 months. UTI as diagnosed by urine culture more than 105 CFU/mL Urine routine microscopy suggestive of increase or normal number of pus cells (white blood cells) per cubic millimetre 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, urinary schistosomiasis. Subjects with cardiac, neurological, renal or hepatic dysfunction. Pregnant & breast-feeding women. Significant medical problems such as uncontrolled hypertension / congestive heart failure or any other medication condition History of ongoing, chronic or recurrent infectious disease / lymphoproliferative disease or history of malignancy of any organ system within the past 5 years. History of Alcohol or smoking abuse.

Design outcomes

Primary

MeasureTime frame
Subjects demonstrating percentage improvement in the terms of efficacy parameters such as laboratory and clinical parametersTimepoint: The whole study treatment is for 14 days with follow up visit at day 7 and 14.

Secondary

MeasureTime frame
Percentage of individuals symptoms free by day 7 (Table 1) Percentage of individuals symptoms free by day 14 (Table 1) Compliance of the subject to the study medication and assessment of adverse effects reported or observed during the study period Timepoint: The whole study treatment is for 14 days with follow up visit at day 7 and 14.

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