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

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

The study is conduct in three hospitals in Erbil governorate in the Kurdistan region of Iraq:

* Shaqlawa Teaching Hospital * Pirmam Teaching Hospital * Rizgary Teaching Hospital These hospitals will be selected based on their patient population, availability of diagnostic facilities, and accessibility for follow-up assessments. Each hospital has specialized urology units and laboratories capable of conducting the required tests, ensuring consistency in data collection.

Data Collection The intervention phase, lasting approximately three to four months, represented the core data collection stage of my study. During this period, I actively visit selected hospitals to recruit participants, ensuring that the study met the required sample size while maintaining methodological rigor.

Based on my sample size calculations, I initially aimed to recruit at least 200 participants, who were then randomly assigned into four groups:

1. Lemon juice + education 2. Roselle + education 3. Education only 4. Control (no intervention)

Follow-up and Schedule

Participants will followed up at four key time points:

* Baseline (Week 0) Initial assessment, which include completing study questionnaire including demographic data, clinical history, dietary habits, life style, knowledge and attitude regarding complementary and alternative medicine (CAM) and urolithiasis parameters (urinalysis and ultrasound). * First follow up (Week 4) First follow-up to assess dietary adherence, symptom changes, side effects and urolithiasis parameters (urinalysis and ultrasound). * Second Follow up (Week 8) Midpoint follow-up for further evaluation of intervention effectiveness which include dietary adherence, symptom changes, side effects and urolithiasis parameters (urinalysis and ultrasound). * Third Follow up (Week 12) Final follow-up to determine long-term changes in urolithiasis characteristics and overall outcomes, which include dietary adherence, symptom changes, side effects and urolithiasis parameters (urinalysis and ultrasound), as well as asking some questions about attitude of participants regarding CAM (the same questions asked from the participant at the baseline assessment) to track and identify changes in their attitude regarding CAM through this period.

Throughout the follow-up period, I will maintain direct contact with participants to ensure adherence and minimize dropouts.

Data Entry and Analysis The data entry and analysis phase, spanning two months, is a critical stage in the study, ensuring that collected data is accurately recorded, processed, and interpreted. During this period, all completed questionnaires, urinalysis reports, and ultrasound findings will be systematically entered into SPSS software to create a structured database for statistical analysis. Data cleaning conducted to identify and correct errors, such as missing values or inconsistencies, ensuring the dataset is reliable and ready for interpretation. Following this, statistical tests will be performed to assess the impact of the dietary interventions and educational program on urolithiasis outcomes, comparing the results across study groups. This step involves both descriptive and inferential statistical methods, such as t-tests, ANOVA, or regression analysis, depending on the nature of the variables and research objectives. The findings are summarized into tables and figures to facilitate interpretation and presentation in the dissertation. As this phase directly influences the validity of study conclusions, meticulous attention is given to accuracy, consistency, and adherence to statistical assumptions.

Participants and Sampling Target Population The target population for this study consists of individuals diagnosed with urolithiasis in Erbil governorate, Iraq, who seek medical care at Shaqlawa, Pirmam, and Rizgary hospitals. These participants represent a diverse demographic group with varying risk factors, dietary habits, and lifestyle behaviors that may influence the development and management of kidney stones.

Inclusion Criteria

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.

Exclusion Criteria

Based on predefined criteria, patients 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.

Sample Size Calculation Sample size was determined using G Power software, setting α = 0.05 and power = 0.80, as a common standard for most research resulting in 50 participants per group, for a total of 200 participants. I selected an effect size of 0.25, which is commonly considered moderate effect size for sample calculation with G power program. It means that lemon juice or Roselle moderately affect urinary stone parameters. Power analysis ensures sufficient sensitivity to detect meaningful differences between intervention and control groups.

Sampling Method A consecutive sampling strategy will be employed, enrolling eligible patients from outpatient urology consultation clinics. It means that every eligible participant who meets the inclusion criteria is systematically recruited until the required sample size is reached. Participants are screened based on their medical history, urinalysis, and ultrasound results to confirm the presence of kidney stones. Eligible individuals who provide informed consent are then assigned to one of four groups, each containing 50 participants: (1) lemon juice + education, (2) roselle + education, (3) education only, and (4) control (no intervention).

Randomization Process To ensure the validity of comparisons between study groups and minimize potential confounding factors, participants randomly assigned to one of the four groups after enrollment. Block randomization is used to achieve a balanced distribution of participants across the groups, ensuring that each group receives an equal number of participants. Blocks of fixed or variable sizes (e.g., 4 or 8 participants per block) are generated, and participants are assigned using a computer-generated randomization list. This method helps prevent imbalances in baseline characteristics, such as age, gender, or stone type, across the groups. The allocation sequence is concealed until the moment of assignment to reduce selection bias. Since the nature of the interventions (lemon juice, roselle, education) makes blinding difficult, the study follows an open-label design, where participants and researchers are aware of the assigned interventions. However, outcome assessors analyzing urinalysis and ultrasound results remain blinded to the intervention groups to minimize assessment bias. This randomization process ensures that differences in outcomes are attributable to the interventions rather than systematic differences between groups.

Research Ethics This study adheres to strict ethical guidelines to ensure the rights, safety, and well-being of all participants. Ethical approval was obtained from the Hawler Medical University ethics committee (Reference number: 2423) before initiating the study, ensuring compliance with national and international research standards (Appendix 1). Additionally, administrative permissions were secured from Shaqlawa, Pirmam, and Rizgary hospitals in Erbil governorate, Iraq, where participant recruitment took place, after initial approval from directorate of health.

All participants provide written informed consent before enrollment, confirming their voluntary participation and understanding of the study objectives, procedures, potential benefits, and risks. The informed consent formed will be translated to Kurdish language which is the native language of the area, and asked participants to carefully read and sign it after taking full information about the study from researcher. They informed that they had the right to withdraw from the study at any time without any consequences for their medical care. Confidentiality and anonymity strictly maintained by assigning unique identification codes instead of using personal information in data records. All data securely stored and accessible only to authorized research personnel.

Additionally, special attention will be given to scientific integrity and data transparency, ensuring that findings were reported accurately without fabrication or manipulation. By upholding these ethical standards, the study guarantees participant protection, data integrity, and adherence to ethical research principles in evaluating the efficacy of dietary and educational interventions for urolithiasis management.

Interventions of the Study Dietary Interventions The study involves two dietary interventions, fresh lemon juice and Hibiscus sabdariffa (roselle) tea, which are provided alongside conventional treatments for urolithiasis. These interventions aim to assess their effectiveness in reducing urinary stone formation, improving symptoms and outcomes, and modifying urinary parameters. More description about each interventional group is discussed below.

A. Lemon Juice Group Participants in this group consume 30-45 ml (one average size citrus lemon) of freshly squeezed lemon juice twice daily, preferably after meals, with a full glass of water to enhance absorption and minimize gastrointestinal discomfort and enamel erosion. The participants are instructed to dilute the lemon juice in water to prevent potential dental enamel erosion from citric acid. Compliance and complications is monitored through follow-up interviews at 4, 8, and 12 weeks to evaluate adherence and effectiveness.

B. Roselle (Hibiscus sabdariffa) Group Participants in this group will be instructed to consume 1.5 g of dried grinded Hibiscus sabdariffa in the form of tea, prepared by pouring 1 teaspoon dried flowers in 100 to 150 ml of hot water fo

• Change in participant attitude score regarding complementary alternative medicine (CAM) [Срок оценки: Baseline and 12 weeks]