Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Bryophyllum pinnatum tea, Placebo tea.
- Who it may be relevant to
- Registry conditions: Kidney Calculi, Calcium Oxalate Kidney Stones, Calcium Phosphate Kidney Stones. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Novel Treatment for Recurrent Kidney Stones
Overview
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.
Interventions
- Combination product Bryophyllum pinnatum tea
24 g of B. pinnatum leaves boiled in 250 mL of water for 61 minutes sweetened with 1/2 teaspoon of sugar - Combination product Placebo tea
250 mL of water boiled with 3 g of wheat-bran for 5 minutes sweetened with 1/2 teaspoon of sugar
Primary outcome measures
- Reduction in 24-hour urine calcium excretion [Time frame: 24 hours after ingestion (day 2 and day 11)]
Secondary outcome measures (2)
- Adverse effects [Time frame: 24 hours after ingestion (day 2 and day 11)]
- Increase in 24-hour urine citrate excretion [Time frame: 24 hours after ingestion (day 2 and day 11)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Crossover
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Canada · 1 center
- McGill University Health Centre (Glen Site) — Montreal
Publications
- 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. PMID 38791318
Identifiers
NCT: NCT06987084 · 2023-8588