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NCT07047742
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Efficacy of Dietary Interventions and Educational Programs as Adjunctive Therapies for the Management of Urolithiasis: Efficacy of Fresh Lemon Juice and Roselle as Educational Program on Urolithiasis Parameters

Sponsor: Hawler Medical University

View on ClinicalTrials.gov

Summary

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).

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-07-01

Completion Date

2025-09-30

Last Updated

2025-07-02

Healthy Volunteers

No

Interventions

DIETARY_SUPPLEMENT

lemon juice

in this study for the first arm fresh lemon juice two times daily is advised

DIETARY_SUPPLEMENT

Roselle

for the second arm Roselle tea is advised tow times per day

OTHER

Education on urolithiasis management

all the arms except control group receive education about urolithiasis management

Locations (1)

Rizgary teaching Hospital, Pirmam teaching hospital, Shaqlawa teaching hospital

Erbil, Iraq