Clinical trial NCT06987084: Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers
Official title: A Novel Treatment for Recurrent Kidney Stones
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: EARLY_PHASE1
Conditions: Kidney Calculi
Calcium Oxalate Kidney Stones
Calcium Phosphate Kidney Stones
Keywords: Kidney stone
Lead sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor class: OTHER
First posted: 2025-05-23
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Each participant will be assigned to one of the following groups:

Group 1: Drink wheat-bran tea (placebo) first then, B. pinnatum tea (treatment).

Group 2: Drink B. pinnatum tea first (treatment), then wheat-bran tea (placebo).

The placebo and the treatment are sweetened with 1/2 teaspoon of sugar.
Primary purpose: PREVENTION

Brief 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.

Detailed description: Background and Rationale:

Kidney stones are hard deposits that consist of calcium complexed with phosphate or oxalate, thus, high urinary calcium content is a major risk factor. The precipitation of calcium can arise from various mechanisms including the aggregation of urinary calcium crystals from impaired transport along the nephron, reduced urinary inhibitors (e.g. citrate), and increased oxidative stress and inflammation. Large stones can block the drainage system of the kidney, causing acute severe pain and inflammation. Recurrent kidney stones can lead to sustained inflammation resulting in a progressive loss of renal function. As the global incidence and economic burden continues to rise there is a undisputed medical need to find preventative measures.

Thiazide diuretics have been fundamental in pharmacological recurrence prevention for the past 60 years. The recent NOSTONE trial (NCT03057431) revealed that the most widely prescribed and best studied thiazide, hydrochlorothiazide, did not reduce the incidence of stone recurrence. There remain significant barriers to kidney stone treatment including high treatment costs, side effects, and the difficulty in achieving long-term dietary and lifestyle changes. Therefore, many patients risk recurrent episodes. New innovative approaches are needed to prevent kidney stone formation.

The leaves of Bryophyllum pinnatum are used to treat a variety of ailments, including the prevention and treatment of kidney stones in various formulations. In a rat kidney stone model, aqueous, alcoholic, and non-alcoholic extracts of B. pinnatum leaves prevented the formation and reduced the size of kidney stones. In an uncontrolled trial, patients with renal stones treated with B. pinnatum juice either passed their stones or showed a reduction in the size of their stones. Despite its established use in other countries, B. pinnatum tea has not undergone rigorous scientific or clinical evaluation. Our lab characterized and standardized the formulation of the tea which revealed anti-urolithiatic activity along with antioxidant and anti-inflammatory properties. A combination of these effects may be what is beneficial in the prevention of recurrent kidney stones.

Eligibility criteria: 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

Primary outcomes:
measure: Reduction in 24-hour urine calcium excretion
timeFrame: 24 hours after ingestion (day 2 and day 11)
Secondary outcomes:
measure: Adverse effects
timeFrame: 24 hours after ingestion (day 2 and day 11)
measure: Increase in 24-hour urine citrate excretion
timeFrame: 24 hours after ingestion (day 2 and day 11)
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: McGill University Health Centre (Glen Site)
state: Quebec
Study officials:
affiliation: Research Institute at the McGill University Health Centre
name: Indra Gupta, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chik C, Larroque AL, Zhuang Y, Feinstein S, Smith DL, Andonian S, Ryan AK, Jean-Claude B, Gupta IR. A Nuclear Magnetic Resonance (NMR)- and Mass Spectrometry (MS)-Based Saturation Kinetics Model of a Bryophyllum pinnatum Decoction as a Treatment for Kidney Stones. Int J Mol Sci. 2024 May 12;25(10):5280. doi: 10.3390/ijms25105280.