Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers (NCT06987084) | Clinical Trial Compass
By InvitationEarly Phase 1
Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers
Canada25 participantsStarted 2024-11-07
Plain-language summary
The aim of this randomized placebo-controlled double-blind crossover clinical trial is to test the ability of a traditional tea made from the leaf of the Bryophyllum pinnatum (B. pinnatum) plant in decreasing urinary calcium content in patients with recurrent calcium-based kidney stones.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18-70 years of age at time of study enrollment
* 1 calcium-based stone event within a 3-year interval and/or hypercalciuria on a 24h urine collection (\>5 mmol/day)
* They had an ultrasound or CT imaging within the previous 6 months which showed no evidence of current obstructive kidney stone
* Adhering to the stone prevention diet (high water/low salt/low protein intake) for at least one month prior to enrollment in study but not taking any stone-preventing medications
* Agrees to maintain current lifestyle habits and avoid taking new supplements during the study period
Exclusion Criteria:
* Patients with secondary causes for calcium stone formation (primary hyperparathyroidism, inflammatory bowel disease, hyperuricosuria, and cancer)
* Patients who are pregnant or nursing or who are trying to become pregnant
* Currently consuming B. pinnatum or any natural health product containing polyphenols
* A known intolerance or allergy to the plant B. pinnatum
* Currently taking stone-preventing medication
* Gluten intolerance or allergy
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Reduction in 24-hour urine calcium excretion
Timeframe: 24 hours after ingestion (day 2 and day 11)