Evaluation of Urinary infections in Diabetic patients

Phase 2

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

Registration Number: CTRI/2019/12/022426

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

Inclusion Criteria

Adult male and female subjects aged more than or equal too 18 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 RBS less than or equal to 160 mg/dL.

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.

Patients unwilling to provide informed consent or abide by the requirements of the study

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.Timepoint: The subject will be assessed clinically at day 7Â±3 days and at day 14Â±3 days (End of Study).

Secondary Outcome Measures

Name	Time	Method
Percentage of individuals symptoms free by day 7 (Table 1) <br/ ><br>Percentage of individuals symptoms free by day 14 (Table 1) <br/ ><br>Compliance of the subject to the study intervention and assessment of adverse effects reported or observed during the study period <br/ ><br>Timepoint: The subject will be assessed clinically at day 7Â±3 days and at day 14Â±3 days(End of Study).