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

Phase 2
Conditions
Health Condition 1: N390- Urinary tract infection, site notspecified
Registration Number
CTRI/2020/03/024271
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 >=18 to <= 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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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