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临床试验/NCT06531993
NCT06531993尚未招募2 期

Effect of Pectin in Chronic Kidney Disease Patients ( Stage 3 and 4 )

Assiut University0 个研究点目标入组 98 人开始时间: 2024年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
尚未招募
入组人数
98
主要终点
effect of pectin in GFR improvement in ckd patients

研究概览

简要总结

Effect of pectin in chronic kidney disease patients

详细描述

Chronic kidney disease (CKD) is a serious global health problem leading to serious comorbidities, end-stage renal disease (ESRD), and death

From 1990 to 2016, the prevalence of CKD increased by 90% worldwide, which is closely tied to the increase in at-risk populations with diabetes mellitus (DM), hypertension (HTN), and prediabetes . It is estimated to be around 9.1 to 13.4%. This means there are about 700 million to over 800 million cases of CKD worldwide.

In 2017, CKD resulted in 1.2 million deaths and was the 12th leading cause of death worldwide . And in the same year, the estimated prevalence of CKD in Egypt was 7.1 million individuals, which means 106 patients/1000 population .

Pectin, a class of heteropolysaccharides based on polygalacturonic acid, is a safe and non-toxic natural food additive recommended by the Joint FAO/WHO Committee on Food Additives with no daily additive limit . Pectin is mainly obtained from apple pomace, citrus peels and sugar beets, ancurrently, commercial pectin contains ≥65% Gal-A (galacturonic acid).

Among the patients who tried to take the pectin, unexpectedly was found that the pectin had a significant effect on the rapid reduction of blood creatinine concentration in patients with chronic kidney disease. So, the authors followed up the physical examination indeces of chronic kidney disease patients who took the Pectin .

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of CKD patients (stage 3 and 4)
  • age between 18 and 60 years
  • Must be able to swallow tablets

排除标准

  • 1- End stage renal disease ( stage 5 ) 2 - Patients with renal transplantation 3- pregnancy 4- Presence of malignancy

研究组 & 干预措施

Placepo group

Placebo Comparator

Standard of care

干预措施: Pectin (Drug)

Pectin group

Active Comparator

Pectin treatment

干预措施: Pectin (Drug)

结局指标

主要结局

effect of pectin in GFR improvement in ckd patients

时间窗: 6 month

Measure eGFR using CKD epi equation,

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Maha Gamal Mahmoud Ahmed

Resident

Assiut University

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