Health Condition 1: N390- Urinary tract infection, site notspecified
Conditions
Interventions
Intervention1: Cystone SF Liquid: This is an open label single arm clinical study. Initially, subjects will be initiated for the informed consent process and then screening will be carried out for eli
Sponsors
The Himalaya Drug Company
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 7±3 days and at day 14±3 days (End of Study). | — |
Secondary
| Measure | Time 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 intervention and assessment of adverse effects reported or observed during the study period Timepoint: The subject will be assessed clinically at day 7±3 days and at day 14±3 days(End of Study). | — |
Countries
India
Contacts
Public ContactDr Palaniyamma
The Himalaya Drug Company
Outcome results
None listed