Kidney CalculiEarly Phase 1NCT06987084
Bryophyllum Pinnatum Tea as a Novel Treatment for Recurrent Kidney Stone Formers
A Early Phase 1 study testing Bryophyllum pinnatum tea in people with Kidney Calculi and Calcium Oxalate Kidney Stones, run by Indra Gupta at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Kidney Calculi, Calcium Oxalate Kidney Stones, Calcium Phosphate Kidney Stones
- What is being tested?
- Bryophyllum pinnatum tea
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 25 participants
- Where
- 1 siteCanada
- Study dates
- 7 Nov 2024to 31 Dec 2025
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
McGill University Health Centre (Glen Site)
Montreal, Quebec, H4A 3J1
About this study
Official title: A Novel Treatment for Recurrent Kidney Stones
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.
Read the 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.
- Being tested
- Bryophyllum pinnatum tea, Placebo tea
- Keywords
- Kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bryophyllum pinnatum teaCombination product
24 g of B. pinnatum leaves boiled in 250 mL of water for 61 minutes sweetened with 1/2 teaspoon of sugar
Placebo teaCombination product
250 mL of water boiled with 3 g of wheat-bran for 5 minutes sweetened with 1/2 teaspoon of sugar
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Combination Product: Bryophyllum pinnatum tea; Combination Product: Placebo tea |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after ingestion (day 2 and day 11)
Secondary outcomes (2)
Adverse effects
Partipants will be asked if they experience any adverse effects immediately after and 24 hours after ingestion.
Measured: 24 hours after ingestion (day 2 and day 11)
Increase in 24-hour urine citrate excretion
After ingestion of the placebo and treatment, participants will begin a 24 hour urine collection. Urinary citrate levels will be reported as mmol/day.
Measured: 24 hours after ingestion (day 2 and day 11)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2025
- Study start7 Nov 2024
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CalculiStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indra Gupta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Indra Gupta, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Indra Gupta, MD, Principal investigator, Research Institute at the McGill University Health Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06987084
- Sponsor's protocol ID
- 2023-8588
- Status last verified
- May 2025
- First submitted
- 6 May 2025
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All anonymized patient data that underlies results in a publication will be shared.
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.
PubMed 38791318
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Treatment for Recurrent Kidney Stones
- ClinicalTrials.gov ID
- NCT06987084
- Acronym / sponsor ID
- 2023-8588
- Keywords
- Kidney stone
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Indra GuptaUniversity, hospital or other
- Study start
- 7 Nov 2024 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| B. pinnatum tea - First | Experimental | Combination Product: Bryophyllum pinnatum tea, Combination Product: Placebo teaParticipants 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. |
| Placebo - First | Experimental | Combination Product: Bryophyllum pinnatum tea, Combination Product: Placebo teaParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bryophyllum pinnatum tea24 g of B. pinnatum leaves boiled in 250 mL of water for 61 minutes sweetened with 1/2 teaspoon of sugar | Combination product | B. pinnatum tea - First, Placebo - First |
| Placebo tea250 mL of water boiled with 3 g of wheat-bran for 5 minutes sweetened with 1/2 teaspoon of sugar | Combination product | B. pinnatum tea - First, Placebo - First |
Primary outcome
Reduction in 24-hour urine calcium excretion
Time frame: 24 hours after ingestion (day 2 and day 11)
After ingestion of the placebo and treatment, participants will begin a 24 hour urine collection. Urinary calcium levels will be reported as mmol/day.
2 secondary outcomes
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 38791318Chik 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.
- Individual participant dataSharing planned: Yes. All anonymized patient data that underlies results in a publication will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Indra Gupta, MD principal investigator
Research Institute at the McGill University Health Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bryophyllum pinnatum tea in people with Kidney Calculi and Calcium Oxalate Kidney Stones, run by Indra Gupta at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction in 24-hour urine calcium excretion (time frame: 24 hours after ingestion (day 2 and day 11)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06987084, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.