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临床试验/NCT07047742
NCT07047742尚未招募不适用

Assess the Efficacy of Dietary Interventions and Educational Programs as Adjunctive Therapies for the Management of Urolithiasis

Hawler Medical University1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
200
试验地点
1
主要终点
Change in kidney stone size measured by ultrasound

研究概览

简要总结

The Efficacy of Dietary and Health Educational Program, as Adjunctive Therapies for the Management of Urolithiasis Introduction Background Urolithiasis, commonly known as kidney stone disease, is a prevalent global health concern affecting millions of individuals annually. The incidence and recurrence of urolithiasis have been increasing due to dietary habits, metabolic disorders, and genetic predispositions (Qian et al., 2022). Kidney stones are crystalline mineral deposits that form within the urinary tract and are classified based on their chemical composition, including calcium oxalate, uric acid, struvite, and cystine stones (Wang et al., 2021).The condition is associated with debilitating symptoms such as renal colic, hematuria, and urinary tract obstruction, leading to significant morbidity and healthcare costs (Urolithiasis EAU Guidelines on, 2023).Conventional management strategies for urolithiasis include pharmacological treatments, extracorporeal shock wave lithotripsy (ESWL), ureteroscopy, and surgical interventions (Fedorowicz et al., 2024). Despite these treatments, high recurrence rates highlight the necessity of preventive strategies through dietary and lifestyle modifications.

Complementary and alternative medicine (CAM) has gained increasing attention in urolithiasis prevention and management, particularly the use of herbal remedies and nutritional interventions. Citrus fruits, particularly lemon juice, have been proposed as effective dietary interventions due to their high citrate content, which inhibits stone formation (Ruggenenti et al., 2022). Additionally, Hibiscus sabdariffa (roselle) has been traditionally used for its diuretic and nephroprotective properties, suggesting potential benefits in preventing urolithiasis (Prasongwatana et al., 2018). However, while these natural interventions have shown promise, there is a lack of strong clinical evidence supporting their efficacy in reducing kidney stone formation and recurrence. Additionally, patient education is crucial in modifying lifestyle behaviors and improving adherence to preventive measures (Gamal et al., 2023). Thus, a comprehensive approach integrating dietary interventions with structured education could be more effective in managing urolithiasis.

Aim of study This study aims to evaluate the efficacy of dietary interventions (fresh lemon juice and Hibiscus sabdariffa) combined with an educational program in managing urolithiasis.

Objectives of study

This dissertation has several objectives which are listed below:

  1. Evaluate the effectiveness of fresh lemon juice, in conjunction with an educational program, on the urinary stones parameters (like stone size, symptoms, infection rate, ...), as well as tracking its potential complications.
  2. Evaluate the effectiveness of Hibiscus sabdariffa (Roselle) in conjunction with an educational program, on the urinary stones parameters (like stone size, symptoms, infection rate, ...), as well as tracking its potential complications.
  3. To determine the effectiveness of educational program on the urinary stones parameters (like stone size, symptoms, infection rate, ...)
  4. To compare the outcomes among four study groups: (i) lemon juice + education, (ii) roselle tea + education, (iii) education-only, and (iv) control (no intervention).
  5. Assess demographic data and clinical status, stone characteristics, lifestyle and dietary habits of participants.
  6. Assess knowledge and attitude of participants regarding complementary and alternative medicine (CAM).

详细描述

Study Design

This study employ a prospective, randomized controlled trial (RCT) design to evaluate the efficacy of dietary interventions-fresh lemon juice and hibiscus sabdariffa (Roselle)-combined with structured education, as adjunctive therapies to conventional treatments for urolithiasis management. The study comprise four parallel groups, each consisting of 50 participants, randomized into the following groups:

  1. Lemon Juice + Education Group Received 30-60 mL of fresh lemon juice twice daily alongside a standardized educational program.
  2. Roselle + Education Group Administered 1.5 g of hibiscus sabdariffa tea twice daily with the same educational intervention.
  3. Education-Only Group Provide solely with the educational program.
  4. Control Group Receive no dietary intervention or education, continuing conventional treatments as prescribed.

The trial duration lasts 12 weeks, with follow-up assessments at 4-week intervals (4th, 8th, and 12th weeks) to monitor adherence, symptom progression, and urinary stone parameters. Randomization was stratified by age and gender to ensure balanced group allocation.

Study Setting

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
None

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •The following aspects is considered for the inclusion of participants in the study:
  • •Adults aged 18-75 years diagnosed with urolithiasis.
  • •Patients are willing to participate and provide informed consent.
  • •Patients do not currently use lemon juice, Roselle, or other herbal treatments for urolithiasis.
  • •No history of severe gastrointestinal disorders or metabolic conditions interfering with dietary interventions.

排除标准

  • •Based on predefined criteria, patients are excluded if they have:
  • •Allergies to citrus fruits or hibiscus.
  • •Chronic kidney disease (CKD) stage 3 or higher.
  • •Pregnancy or lactation.
  • •Gastrointestinal disorders (e.g., GERD, ulcers, chronic gastritis for lemon juice group).
  • •Metabolic disorders (e.g., hyperparathyroidism, gout, hyperoxaluria).
  • •Recent urolithiasis surgery (within the last 3-6 months).
  • •Severe systemic diseases (e.g., cancer, advanced cardiovascular diseases).
  • •Hypertension requires diuretics (due to potential interaction (synergic effect) between dietary interactions and prescribed medications for hypertension which may lead to hypotension).
  • •Malabsorption disorders (e.g., Crohn's disease, celiac disease).
  • •Non-compliance with study protocols. The exclusion criteria ensure homogeneity in the study sample and improve the reliability of intervention assessment.

研究组 & 干预措施

lemon juice group

Experimental

this group receive lemon juice as well as education about urolithiasis management as adjunctive therapy to their conventional treatments. the total participants of this group will be 50 participants.

干预措施: lemon juice (Dietary Supplement)

lemon juice group

Experimental

this group receive lemon juice as well as education about urolithiasis management as adjunctive therapy to their conventional treatments. the total participants of this group will be 50 participants.

干预措施: Education on urolithiasis management (Other)

Roselle group

Experimental

this group receive Roselle as well as education about urolithiasis management as adjunctive therapy to their conventional treatments. the total participants of this group will be 50 participants.

干预措施: Roselle (Dietary Supplement)

Roselle group

Experimental

this group receive Roselle as well as education about urolithiasis management as adjunctive therapy to their conventional treatments. the total participants of this group will be 50 participants.

干预措施: Education on urolithiasis management (Other)

education

Experimental

this group receive only education about urolithiasis management as adjunctive therapy to their conventional treatments. the total participants of this group will be 50 participants.

干预措施: Education on urolithiasis management (Other)

control group

No Intervention

this group is a control group. they receive no intervention and just receive their coventional treatment. the total participants of this group will be 50 participants.

结局指标

主要结局

Change in kidney stone size measured by ultrasound

时间窗: Baseline and 12 weeks after intervention

Change in the largest diameter (in mm) of kidney or ureteral stones as measured by abdominal ultrasound.

次要结局

  • Change in participant attitude score regarding complementary alternative medicine (CAM)(Baseline and 12 weeks)

研究者

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

Dler Mohammed Saeed

Assistant lecturer

Hawler Medical University

研究点 (1)

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