Health Condition 1: N209- Urinary calculus, unspecified
Conditions
Interventions
None listed
Sponsors
Himalaya Wellness Company
Eligibility
Inclusion criteria
Inclusion criteria: 1.Subjects diagnosed with single or multiple urinary stones (kidney, bladder, or ureters) between 4mm and 7mm in size, as confirmed by USG KUB. 2.Subjects with or without symptoms related to urinary stones (e.g., flank or abdominal pain, possibly radiating to the groin or genitalia). 3.Subjects willing to avoid oral medication for stone-related disorders (except for analgesics and anti-spasmodics as needed). 4.Subjects who have not participated in any similar clinical study in the last 3 months. 5.Subjects willing to sign informed consent and adhere to the study procedures. 6.Women of childbearing potential and men with partners of childbearing potential must agree to use contraception (hormonal or barrier method) during the study and for 90 days afterward. 7.Male participants must refrain from sperm donation during the study and for 90 days following completion.
Exclusion criteria
Exclusion criteria: 1.Subjects with severe symptomatic stones or stones more than 7mm or total burden more than 20mm. 2.Subjects with renal insufficiency, complicated UTI, kidney tumors, sepsis, or other renal diseases that may interfere with the study. 3.Subjects on medications (e.g., alpha blockers, corticosteroids, diuretics) within the past 15 days that may affect the study. 4.Subjects with significant chronic conditions (e.g., uncontrolled diabetes, hypertension) or any condition affecting study compliance. 5.Subjects allergic to the investigational product or its ingredients. 6.Pregnant or lactating women or those with a history of amenorrhea. 7.History of alcohol or substance abuse. 8.Any condition that may affect study participation in the investigator?s opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy: Proportion of subjects with stone expulsion. (Stone Free Rate: SFR) Time (mean days) to stone expulsion Reduction in size of calculi/ total stone burden. Use of Rescue medication (Analgesics, Anti-spasmodics) Improvement in urinary symptoms Pain Intensity Scale Quality of life Timepoint: Day 0, Day 1, Day 14, Day 28 & Day 42. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events during the study period. Proportion of subjects withdrawn from trial because of adverse events (tolerability).Timepoint: Day 0, Day 1, Day 14, Day 28 & Day 42. | — |
Countries
India
Contacts
Public ContactDr Soorya Narayan H
Himalaya Wellness Company
Outcome results
None listed