Health Condition 1: N200- Calculus of kidney Health Condition 2: N390- Urinary tract infection, site notspecified Health Condition 3: N398- Other specified disorders of urinary system
Conditions
Interventions
None listed
Sponsors
Ethniq Ayush Exports LLP
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age Male or female patients aged 18 to 65 years for the Kidney Stone and UTI arms. Male patients aged 30 to 70 years for the BPH arm. 2.Diagnosis For the Kidney Stone arm, patients with presence of kidney stones measuring up to twelve millimeters confirmed by ultrasound imaging. 3.For the UTI arm, patients with presence of urinary tract infection symptoms such as dysuria, frequent urination, or burning during micturition, confirmed by urine culture and sensitivity testing. 4.For the BPH arm, patients with lower urinary tract symptoms with an International Prostate Symptom Score of eight or more at screening. Ultrasound confirmed prostate enlargement with prostate volume of thirty milliliters or more. Post void residual urine volume measurable by ultrasound. 5.General Health Participants should be generally healthy and should not have severe comorbid conditions that may interfere with the study outcomes. 6.Informed Consent Participants should be willing to voluntarily sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1.Severe Medical Conditions Patients with serious cardiovascular, cerebrovascular, respiratory, hepatic, or advanced renal disease. Patients with other concurrent urological disorders. 2.Chronic Conditions Patients with uncontrolled diabetes mellitus. Patients with uncontrolled hypertension. Patients with symptomatic congestive heart failure. 3.BPH Arm Patients with history or evidence of prostate cancer. Patients with prior prostate or bladder surgery within the last six months. Any medical condition that may place the patient at undue risk during study participation. 4.Pregnancy and Lactation Pregnant or lactating women where applicable. 5.Substance Abuse Patients with history of excessive alcohol consumption or drug abuse. 6.Use of Investigational Products Patients who have participated in another clinical trial or used any investigational product within the past thirty days. 7.UTI Related Exclusions Patients with recurrent urinary tract infections requiring systemic antibiotic treatment during the study period. Patients with antibiotic resistant bacterial infections identified during baseline sensitivity testing. 8.Allergies Patients with known allergy or hypersensitivity to any ingredient of the investigational products including Uro Fizz effervescent tablets or tea bags.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Kidney Stones Arm Change in kidney stone size and number assessed by ultrasound at baseline and Day forty five. UTI Arm Bacterial clearance assessed by urine culture at baseline and Day forty five. BPH Arm Change in prostate volume and post void residual urine volume assessed by ultrasound at baseline and Day forty five.Timepoint: Day 0, Day 15 3 Day 30 3 Day 45 3 | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptom Relief Improvement in symptoms for kidney stones, UTI, & BPH assessed during follow up visits up to Day forty five. Kidney Stones Arm Stone expulsion & renal function assessed at baseline & Day forty five. Quality of Life Change in quality of life assessed at baseline & Day forty five. Safety Adverse events & renal function monitored throughout the study. Patient Compliance Assessed through drug accountability records.Timepoint: Day 0, Day 15 3 Day 30 3 Day 45 3 | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed