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临床试验/NCT07444515
NCT07444515招募中不适用

Prospective Analysis of Self Medication With Phytotherapy in Nephropatic Patients.

Centre Hospitalier Universitaire de la Réunion5 个研究点 分布在 1 个国家目标入组 400 人开始时间: 2026年7月28日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
400
试验地点
5
主要终点
Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline

研究概览

简要总结

We propose the following hypotheses:

  • The use of herbal medicine is common among patients with chronic kidney disease in Réunion island.
  • This use could influence the progression of kidney disease in these patients. To assess the primary inclusion criterion, patients will be easily identified by nephrologists through existing follow-up. The questionnaires will be administered after this early identification by the investigators at each center.

The primary evaluation criterion is straightforward: it aims to establish an overview of the use of herbal medicine in our patient population. This information is currently unavailable and remains crucial for measuring the extent of the issue. Our secondary criteria will involve more in-depth analysis of this use and an attempt to correlate the use of certain herbs with the rate of progression of kidney disease at one year.

We targeted patients with moderate to end-stage chronic kidney disease (KDIGO classification 3 to 5), which are the stages typically included in kidney disease studies. Furthermore, these patients are the most likely to experience a greater annual progression of their kidney disease, and the effect of herbs on this progression could be investigated. Transplant patients were not included because they are more aware of the risks of not using herbal medicine due to their use of immunosuppressants.

详细描述

The use of traditional medicine is widespread globally. In Africa, the prevalence is estimated at 60%, while usage in developing countries may reach 80%. Phytotherapy is defined as the treatment or prevention of diseases using plants; it plays a role in both traditional medicine and the current "modern" market. Chronic kidney disease (CKD) is one of the most common chronic conditions worldwide, with over 800 million prevalent cases. Its prevalence is steadily rising, affecting high-income and low-to-middle-income countries alike. Patients with kidney disease may be heavily exposed to phytotherapy.

Phytotherapy has long been used to treat kidney disease, and the kidneys are a primary route for the elimination of plant-derived compounds and their metabolites. While some plants appear to possess nephroprotective properties, others may cause acute kidney injury, chronic kidney disease, kidney stones, Fanconi syndrome, or urothelial cancers. Patients with chronic kidney disease may be at particular risk of nephrotoxicity due to reduced nephron mass and polypharmacy.

Currently, there is very little data regarding the use of phytotherapy among patients with chronic kidney disease, or concerning its protective or toxic effects.

In Réunion, there is a strong culture of phytotherapy-known as *z'herbages* in Réunionese Creole. Réunion is also the French department with the highest prevalence of end-stage renal disease. Patients with chronic kidney disease in Réunion may frequently use phytotherapies-whether for renal or systemic purposes-the consequences of which remain unknown. There is therefore a clear need to map these practices in order to identify candidate plants with potential nephroprotective or nephrotoxic effects.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Health Services Research
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Individual:
  • Resident of Réunion Island and planning to remain on the island for the year following enrollment
  • Chronic Kidney Disease Stage 3, 4, or 5, not on dialysis
  • Under the care of a nephrologist
  • Able to complete a questionnaire
  • Registered with social security

排除标准

  • Individual:
  • Kidney transplant recipient
  • Adult under guardianship or legal protection
  • Pregnant or breastfeeding women, or women planning a pregnancy during the enrollment period

研究组 & 干预措施

All patient with kidney chronic disease

Experimental

干预措施: series of questions which can change patient care (Other)

结局指标

主要结局

Proportion of patients with stage 3 to 5 CKD using traditional herbal medicine at baseline

时间窗: baseline

次要结局

未报告次要终点

研究者

发起方
Centre Hospitalier Universitaire de la Réunion
申办方类型
Other
责任方
Sponsor

研究点 (5)

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