Health Condition 1: N200- Calculus of kidney
Conditions
Interventions
None listed
Sponsors
Aimil Pharmaceuticals (India) Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1.Participants of either sex aged 18 to 65 years 2.Willing to sign informed consent and comply with the requirements of the study protocol 3.Participants with diagnostic reports (plain X-ray, ultrasound sonography, or CT scan) for renal calculi. 4.Participants with the calculi size ranging from 4 mm to less than 10 mm.
Exclusion criteria
Exclusion criteria: 1.Pregnant and lactating women 2.Known allergies to any component of the study intervention. 3.Patients with acute or complicated conditions of kidney stones. 4.Subjects who have taken other drugs or herbal supplements for stone disease in the previous 3 months. 5.Participants with chronic or active disease, such as kidney failure, liver disorder, cancer, myocardial infarction, uncontrolled diabetes, uncontrolled hypertension, symptomatic congestive heart failure, and chronic kidney infection. 6.Evidence of significant concomitant disease that, in the view of the principal investigator, that would prevent patient participation 7.Participants suffering from a mental illness or other condition that would make it difficult to meet the study requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢Change in the size of renal stones from baseline to end of the study assessed by using ultrasound sonography (USG). â?¢Change in the number of renal stones from baseline to end of the study assessed by using USG. Timepoint: day -2, day 0, day 60, day 120 | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢Mean change in the symptom severity score from screening to end of the study â?¢Mean changes in the levels of serum calcium, serum phosphorous, serum magnesium & serum uric acid and oxalate in urine from screening to end of the study â?¢Mean changes in the vital signs from screening to end of the study. â?¢Mean changes in the serum levels of BUN and Sr. creatinine from screening to end of the study â?¢Mean changes in the serum levels of SGPT and SGOT from screening to end of the study â?¢Mean changes in the CBC parameters from screening to end of the study â?¢Occurrences and frequencies of adverse and serious adverse events during the study period Timepoint: day -2, day 0, day 60, day 120 | — |
Countries
India
Contacts
Public ContactHasan Ali Ahmed
Xplora Clinical Research Services Pvt. Ltd
Outcome results
None listed