Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers

NCT06987084 | Enrolling By Invitation Early Phase 1

• 1 other identifier: 2023-8588
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Calculi; Calcium Oxalate Kidney Stones; Calcium Phosphate Kidney Stones

Keywords

Kidney stone

Outcome Measures

Primary Outcomes (1)

• Reduction in 24-hour urine calcium excretion

  After ingestion of the placebo and treatment, participants will begin a 24 hour urine collection. Urinary calcium levels will be reported as mmol/day.

  24 hours after ingestion (day 2 and day 11)

Secondary Outcomes (2)

• Adverse effects

  24 hours after ingestion (day 2 and day 11)

• Increase in 24-hour urine citrate excretion

  24 hours after ingestion (day 2 and day 11)

Study Arms (2)

B. pinnatum tea - First

EXPERIMENTAL

Participants in this arm will receive 250 mL of sweetened B. pinnatum tea on day 1 and then on day 2, they will submit urine and blood for analysis for biochemistry. On day 10, participants will receive 250 mL of sweetened placebo tea. On day 11, they will again submit a 24-hour urine collection and a blood sample for analysis.

Combination Product: Bryophyllum pinnatum tea; Combination Product: Placebo tea

Placebo - First

EXPERIMENTAL

Participants in this arm will receive 250 mL of sweetened placebo tea on day 1 and then on day 2, they will submit urine and blood for analysis for biochemistry. On day 10, participants will receive 250 mL of sweetened B. pinnatum tea. On day 11, they will again submit a 24-hour urine collection and a blood sample for analysis.

Combination Product: Bryophyllum pinnatum tea; Combination Product: Placebo tea

Interventions

Bryophyllum pinnatum tea COMBINATION_PRODUCT

24 g of B. pinnatum leaves boiled in 250 mL of water for 61 minutes sweetened with 1/2 teaspoon of sugar

B. pinnatum tea - First; Placebo - First

Placebo tea COMBINATION_PRODUCT

250 mL of water boiled with 3 g of wheat-bran for 5 minutes sweetened with 1/2 teaspoon of sugar

B. pinnatum tea - First; Placebo - First

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age at time of study enrollment
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indra Gupta: lead

Study Sites (1)

McGill University Health Centre (Glen Site)

Montreal, Quebec, H4A 3J1, Canada

Location

Related Publications (1)

• 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 BACKGROUND

MeSH Terms

Conditions

Kidney Calculi

Condition Hierarchy (Ancestors)

Nephrolithiasis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Urolithiasis; Urinary Calculi; Male Urogenital Diseases; Calculi; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Indra Gupta, MD

  Research Institute at the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Both the B. pinnatum tea and the placebo tea will be provided in identical dark thermoses with a lid. The placebo wheat-bran tea tastes and looks identical to the treatment, B. pinnatum tea.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: May 6, 2025
• First Posted: May 23, 2025
• Study Start: November 7, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: May 23, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available 6 months after publication.
• Access Criteria: All data will be anonymized for publication. Only the study investigators will have access to individual patient data.

Locations

CA (1)