Health Condition 1: N200- Calculus of kidney
Conditions
Interventions
Intervention1: Stonvil Capsule: 2 capsules in the morning and 2 capsules in the night, after food for 90 days
Control Intervention1: NA Single Arm Study: NA Single Arm Study
Sponsors
SG Phyto Pharma Pvt Ltd
Aurous HealthCare Research and Development India Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adult subjects >=18 years of age diagnosed with Renal Calculi (both sexes inclusive) 2. Renal Calculi to be confirmed by USG. A minimum of 1 calculi; sized >=3mm with crystals. 3. Subject/LAR who is willing to give informed consent for participation, able to comprehend and understand the responsibilities during treatment period and follow up period. 4. Subjects who are willing not to participate in any other clinical trial during participation in the current trial.
Exclusion criteria
Exclusion criteria: 1. Subjects with known hypersensitivity to herbal investigational product or its constituents. 2. Subjects who require or are scheduled for or have previously undergone lithotripsy. 3. Subjects with calculus condition requiring surgery; not limited to hydronephrosis, hydrocalycosis; struvite and cystic stones 4. Subjects with current or chronic infection not limited to urinary tract infection; chronic renal infection. 5. Subjects with clinically abnormal renal function parameters that are to deemed by the Investigator/ CRMC as interfering with the study objectives. 6. Subjects on medications/herbal supplements for renal calculi. 7. Subjects with immunucompromised state complications. 8. Subjects with uncontrolled diabetes, hypertension or congestive heart failure. 9. Any significant medical condition (e.g., significant psychiatric or neurological disorders, active alcohol/drug abuse, etc.), any medical condition that is unstable/poorly controlled or other factor (e.g., planned relocation) that the Investigator felt would interfere with study evaluations and study participation. 10. Subjects who have participated in any clinical study within 3 months from the date of enrolment. 11. Females who are pregnant or lactating or planning to become pregnant during the study period. 12. Subjects who mentally unable to comprehend the responsibilities and adhere to the stipulations of the protocol. 13. Subjects, who in the opinion of the Investigator/CRMC are not eligible for enrolment in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Reduction in size of Renal Calculi: â?¥50% reduction in size of renal calculi. 2. Disintegration of Renal Calculi: 100% disintegration of renal calculi 3. Disintegration of Renal Calculi: â?¥50% disintegration of renal calculi Timepoint: 1. Day 1, Day 45, Day 90 2. Day 1, Day 45, Day 90 3. Day 1, Day 45, Day 90 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain Reduction: â?¥50% reduction in pain and symptoms associated with Renal Calculi. 2. Quality of Life: Score of â?¥15 by end of study. Timepoint: 1. Day 1, Day 45, Day 90 2. Day 1, Day 45, Day 90 3. Day 1, Day 45, Day 90 | — |
Countries
India
Contacts
Public ContactDr VT Sriraam
Aurous HealthCare R & D India Private Limited
Outcome results
None listed