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 range18 Years – 70 Years
SexALL
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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
What they're measuring
1
Reduction in 24-hour urine calcium excretion
Timeframe: 24 hours after ingestion (day 2 and day 11)