Health Condition 1: N22- Calculus of urinary tract in diseases classified elsewhere
Conditions
Interventions
None listed
Sponsors
UMA Ayurvedic Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged 18 to 75 years, of either gender 2.Diagnosis of urinary stones confirmed by ultrasound scan 3.Size of the urinary stones must be less than 15mm in maximum diameter 4.Subjects who are first time stone formers or with a history of recurrent urinary stones, presenting with symptoms such as flank pain, dysuria, or hematuria 5.Willingness to comply with the study protocol and attend all scheduled visits 6.Ability and willingness to provide written informed consent
Exclusion criteria
Exclusion criteria: 1.Pregnant or lactating women 2.Subjects with any systemic disease requiring other medications or surgical intervention for their calculus condition 3.Body Mass Index which is greater than 40 kg per meter square due to the impact on hydration and metabolic balance 4.Cases requiring immediate surgical management or presenting with complicated urolithiasis 5.Active urinary tract infection or chronic renal infection 6.Subjects with uncontrolled diabetes mellitus, hypertension, symptomatic congestive heart failure, unstable angina, or recent myocardial infarction 7.Presence of other urogenital disorders that may interfere with outcomes 8.Use of any herbal or plant-based supplement for kidney stones within the past 3 months 9.Participation in another clinical study within 30 days prior to screening 10.Active alcohol or substance abuse, or history of the same within the last 24 weeks 11.Any psychiatric illness or condition that may affect adherence to the protocol 12.Any other medical condition, in the investigator s opinion, that could compromise the safety of the Subject or study integrity
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The Change in urinary stone size and number from Baseline to the End-of-Treatment, as measured by ultrasound imaging. Stone Size: Measured in millimeters using standardized ultrasonographic techniques. Stone Number: Total count of stones present in the kidney, ureter, or bladder. 2.Rationale: Reduction in stone burden is the most objective and clinically relevant marker of treatment efficacy in urolithiasis management. Timepoint: Day 0, Day 15, Day 30, Day 45 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Symptom Relief: Improvement in urinary stone-related symptoms, assessed using the Visual Analog Scale. 2.Change in Quality of Life score from Baseline to End-of-Treatment, assessed using a validated disease-specific QoL questionnaire. Safety Endpoints: 1. Incidence of Adverse Events (AEs) and Serious Adverse Events (SAEs) will be monitored throughout the study duration. 2. Changes in hematological and renal function parameters including CBC and RFT will be assessed at Baseline (Day 0) and End-of-Treatment (Day 45).Timepoint: Day 0, Day 15, Day 30, Day 45 | — |
Countries
India
Contacts
Public ContactMs Arpita Malgi
Samahitha Research Solutions
Outcome results
None listed