Health Condition 1: N201- Calculus of ureter
Conditions
Interventions
Intervention1: Tea bags: Tea bags of Dolichos biflorus Seeds with standard treatment of urolithiasis, Route of administration shall be Oral, Two tea bags shall be administered thrice a day for 2 month
Sponsors
Ravi Kant
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients with a diagnosis of symptomatic urolithiasis will be selected to participate in the study. 2. Eligible patients will be males or non-pregnant, non-lactating females; 18-75 years of age (inclusive of both); with diagnosis of symptomatic urolithiasis disease. 3. The patients of symptomatic urolithiasis with renal stone burden ( 4. Patients able to make proper use of medication. 5. Female patients of childbearing potential - they are willing to use a medically valid and effective contraception throughout the study period. 6. Patients willing to provide written informed consent
Exclusion criteria
Exclusion criteria: 1. Known hypersensitivity or allergies to any component of the IMP (in any dosage form). 2. Patients with chronic renal failure, extensive comorbidity, sepsis, and prior metabolic abnormalities. 3. The patients of symptomatic urolithiasis with renal stone burden ( >8 mm), as determined by ultrasound/X-ray KUB. 4. The patient required surgical intervention as per clinical judgement by investigator. 5. The patient with other comorbidity(ies) which prohibit participation of patient in this study as per clinical judgement by investigator. 6. Use of any investigational drug or investigational device within 30 days prior to randomization. 7. Patient consumes excessive alcohol, abuses drugs, or has a condition that could compromise the patientâ??s ability to comply with study requirements. 8. Female patient with ongoing pregnancy. 9. Patients who are mentally incapacitated such that informed consent cannot be obtained.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Stone passage during therapy or reduction in size/number of stones with therapy up to 8 weeks of treatment whichever is earlierTimepoint: Stone passage during therapy or reduction in size/number of stones with therapy up to 8 weeks of treatment whichever is earlier | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety assessmentTimepoint: 8 weeks | — |
Countries
India
Contacts
Public ContactAadarsh Chaubey
College of Pharmacy, Chitkara University
Outcome results
None listed