Bryophyllum Pinnatum Tea for Kidney Stones

Age: 18+

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indra Gupta

Must not be taking: Stone-preventing medications

Disqualifiers: Pregnancy, Cancer, Gluten intolerance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 11 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a tea made from Bryophyllum pinnatum leaves can reduce urinary calcium levels in individuals who frequently experience calcium-based kidney stones. The goal is to determine if this tea can prevent further stone formation by lowering calcium in the urine. Participants will begin with either the tea or a placebo (a non-active version of the tea for comparison) and then switch, enabling researchers to compare results. This trial may suit those who have had at least one calcium-based kidney stone in the past three years and follow a special diet to prevent stones. As an Early Phase 1 trial, this research focuses on understanding how the treatment works in people, offering participants a chance to contribute to groundbreaking research.

Will I have to stop taking my current medications?

If you are currently taking stone-preventing medications, you will need to stop them to participate in this trial. The trial does not specify about other medications, so it's best to discuss with the trial team.

Is there any evidence suggesting that Bryophyllum Pinnatum Tea is likely to be safe for humans?

Research has shown that Bryophyllum pinnatum, a plant used in traditional medicine, may help treat kidney stones. In studies with rats, extracts from B. pinnatum leaves prevented and shrank kidney stones. Further research found that these leaf extracts could lower urine oxalate levels, which helps prevent kidney stones.

Regarding human safety, the tea is in early clinical testing, so limited information exists on its safety for people. Early trials focus mainly on safety, and any serious side effects would likely halt the study. Bryophyllum pinnatum's traditional use suggests it might be safe, but waiting for more solid evidence from ongoing studies is important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Unlike standard treatments for kidney stones, which often involve medication, surgery, or sound wave therapy to break down the stones, Bryophyllum Pinnatum tea is derived from a natural plant source. Researchers are excited about this treatment because it offers a potentially less invasive and more natural approach to managing kidney stones. The tea's active compounds may help dissolve and prevent stones, providing an alternative to more aggressive methods. Plus, the use of a simple tea could make it more accessible and appealing for those looking for herbal or non-surgical options.

What evidence suggests that Bryophyllum Pinnatum Tea might be an effective treatment for kidney stones?

Research has shown that Bryophyllum pinnatum tea might help people with kidney stones. In an earlier study, patients who drank B. pinnatum juice either passed their kidney stones or saw them shrink. Another study found that the leaves of B. pinnatum significantly lowered urine oxalate levels, often linked to stone formation. Additionally, extracts from this plant reduced harmful changes in urine and blood caused by kidney stones. In this trial, participants will receive either B. pinnatum tea or a placebo to evaluate its effectiveness in managing kidney stones by reducing their size and formation. ^{1 2 4 5 6}

Who Is on the Research Team?

Indra Gupta, MD

Principal Investigator

Research Institute at the McGill University Health Centre

Are You a Good Fit for This Trial?

This trial is for people who frequently get calcium-based kidney stones. Participants should be adults with a history of these stones and willing to drink assigned teas regularly. Specific health conditions or medications that could interfere with the study are reasons for exclusion.

Inclusion Criteria

I have had a kidney stone or high calcium in my urine in the last 3 years.

Had an ultrasound or CT imaging within the previous 6 months showing no evidence of current obstructive kidney stone

Agrees to maintain current lifestyle habits and avoid taking new supplements during the study period

Exclusion Criteria

I have a condition like hyperparathyroidism or IBD that causes calcium stones.

Patients who are pregnant or nursing or who are trying to become pregnant

I am currently taking B. pinnatum or products with polyphenols.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either B. pinnatum tea or placebo and undergo urine and blood analysis

11 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Bryophyllum Pinnatum Tea

Trial Overview The study tests if Bryophyllum pinnatum tea can reduce urinary calcium in recurrent kidney stone patients, compared to a placebo tea. It's randomized and double-blind, meaning neither researchers nor participants know who gets the real or placebo tea until after results.

How Is the Trial Designed?

Group I: Placebo - First Experimental Treatment 2 Interventions

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.

Group II: B. pinnatum tea - First Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Indra Gupta

Lead Sponsor

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06987084

Bryophyllum Pinnatum Tea as a Novel Treatment for ... 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 ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4104626/

Evaluation of anti-urolithiatic effect of aqueous extract of ... Administration of aqueous extract of leaves of B. pinnatum reduced urine oxalate level significantly, as compared with Group B (p<0.001).

3. sciencedirect.com sciencedirect.com/science/article/pii/S2225411021000614

Anti-urolithiatic activity of Bryophyllum pinnatum Lam. ... The current study found that hydro-alcoholic extracts of Bryophyllum pinnatum had a beneficial impact in reducing NaOx-induced changes in urine and serum ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11121557/

Based Saturation Kinetics Model of ... These metabolites are beneficial for treating kidney stones because they target oxidative stress and inflammation and inhibit stone formation. Keywords: kidney ...

5. withpower.com withpower.com/trial/bryophyllum-pinnatum-tea-for-kidney-stones-76230

Bryophyllum Pinnatum Tea for Kidney Stones Trial Overview The study tests if Bryophyllum pinnatum tea can reduce urinary calcium in recurrent kidney stone patients, compared to a placebo tea. It's ...

6. nakraayurveda.com nakraayurveda.com/vanplandu-bryophyllum-pinnatum/

Vanplandu (Bryophyllum pinnatum) - uses, dosage, home ... For Kidney Stones: A few fresh leaves boiled in water can be consumed once a day to help dissolve kidney stones. For Cough and Cold: Freshly extracted leaf ...