Health Condition 1: N200- Calculus of kidney
Conditions
Interventions
Intervention1: Investigational Tablet- Kidflame Tablet: All eligible subjects who meet the Inclusion and Exclusion will be enrolled into the study will have to visit the study site on screening, Day 0
Sponsors
Bhargava Phytolab Limited
Eligibility
Inclusion criteria
Inclusion criteria: The Inclusion criteria are as follows (â??Yesâ?? to the following will allow the subjects to be included into study) 1. Age: Adult-Above 18 years to 60 years, both male and female 2. Willing to sign written inform consent 3. Patients recently diagnosed with renal stone, the following signs and symptoms Pain in back radiating from back to groin Nausea and vomiting Frequent Urination Burning Micturition 4. Confirmation of stone by USG KUB region- Measurable stone 5. Non-complicated Kidney Stone(s) size over 3 mm to 18 mm
Exclusion criteria
Exclusion criteria: The exclusion criteria are as follows (â??Yesâ?? to any one of the following will allow PI to exclude the subject from enrolling into the study 1. Age: below 18 years to above 60 years, both male and female 2. Not willing to sign written inform consent 3.Size of single stone less than 3 mm 4. Active urinary tract infection 5. Complex stone anticipating multiple access site 6. Stones that are not clearly able to be measured on USG-KUB 7. Severe Hydronephrosis/ pylenephrosis 8. Cystitis 9. Patients with known history of DM and HTN 10.H/o renal, hepatic or blood disorder or severe cardiac insufficiency 11. Known history of hypersensitivity to herbal extracts or dietary supplements which is present in this formulation 12. Subjects with ongoing fever 13. Pregnant women, lactating women and women of child bearing potential not following adequate contraceptive measure, women who were found positive for urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in size of stone/expulsion of stone (Both confirm by USG)Timepoint: Reduction in size of stone/expulsion of stone (Both confirm by USG) after 2 month | — |
Secondary
| Measure | Time frame |
|---|---|
| Reduction in symptoms of Urolithiasis and mean change in Urolitiasis Symptom Score.Timepoint: 60 Days | — |
Countries
India
Contacts
Public ContactMs Sonal Mhashilkar
Milagro Clinical Research
Outcome results
None listed