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

NCT07047742 | Not Yet Recruiting

• 1 other identifier: 2423
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 3.To determine the effectiveness of educational program on the urinary stones parameters (like stone size, symptoms, infection rate, …)
4. 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. 5.Assess demographic data and clinical status, stone characteristics, lifestyle and dietary habits of participants.
6. 6.Assess knowledge and attitude of participants regarding complementary and alternative medicine (CAM).

Conditions

Urolithiasis, Lemon Juice

Outcome Measures

Primary Outcomes (1)

• Change in kidney stone size measured by ultrasound

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

  Baseline and 12 weeks after intervention

Secondary Outcomes (1)

• Change in participant attitude score regarding complementary alternative medicine (CAM)

  Baseline and 12 weeks

Study Arms (4)

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.

Dietary Supplement: lemon juice; Other: Education on urolithiasis management

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.

Dietary Supplement: Roselle; Other: Education on urolithiasis management

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.

Other: Education on urolithiasis management

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.

Interventions

lemon juice DIETARY_SUPPLEMENT

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

lemon juice group

Roselle DIETARY_SUPPLEMENT

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

Roselle group

Education on urolithiasis management OTHER

all the arms except control group receive education about urolithiasis management

Roselle group; education; lemon juice group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hawler Medical University: lead

Study Sites (1)

Rizgary teaching Hospital, Pirmam teaching hospital, Shaqlawa teaching hospital

Erbil, Iraq

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Central Study Contacts

Dler Mohammed Saeed

CONTACT

00964 7512062291; dler.saeed@epu.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: July 1, 2025
• Primary Completion: August 1, 2025
• Study Completion: September 30, 2025
• Last Updated: July 2, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)