A Novel Treatment for Recurrent Kidney Stones
试验速览
- 阶段
- 1 期
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Reduction in 24-hour urine calcium excretion
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Reduction in 24-hour urine calcium excretion
时间窗: 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.
次要结局
- 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))
研究者
Indra Gupta
Associate Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre