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

Phase 2/3

Not yet recruiting

Brief Summary: This is an open label two arm randomised clinical study. Initially,subjects will be initiated for the informed consent process and then screeningwill be carried out for eligibility check. Subjects will be screened andrandomized to 2 arms. Arm 1 subjects will receive standard care of treatmenttwice daily for a period of 14 days and Arm 2 subjects will receive standardcare of treatment + 10 ml of Cystone SF liquid twice daily for a period of 14days. Thewhole study treatment is for 14 days with follow up visit at day 7 and 14. This study is dividedinto Screening period, Active Treatment period and End of Study.

Recruitment & Eligibility

Inclusion Criteria

Adult male and female subjects aged â‰¥18 to â‰¤ 65 years presenting atleast two of the following UTI symptoms like urgency, dysuria, frequency of micturition (nos), suprapubic pain, haematuria, burning micturition, fever, flank pain, chills, nausea and emesis.
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

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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Percentage of individuals symptoms free by day 7 (Table 1)	Percentage of individuals symptoms free by day 14 (Table 1)

Locations (1): Srikumaran Health Centre (p) Ltd
🇮🇳
Chennai, TAMIL NADU, India
Srikumaran Health Centre (p) Ltd
🇮🇳Chennai, TAMIL NADU, India
Dr T Srinivasan
Principal investigator
9442217211
srinivasan.euro@gmail.com