GAESRDGum Arabic Impact on Residual Renal Function in ESRD Dialysis Patients
This study aims to evaluate the effect of Gum Arabic on the kidney function of end stage renal disease patients on dialysis, by measuring the improvement in urea and creatinine clearance in a full 24-hour urine collection.
Gum Arabic
+ Water
Urogenital Diseases+10
+ Chronic Disease
+ Female Urogenital Diseases and Pregnancy Complications
Treatment Study
Summary
Study start date: February 3, 2025
Actual date on which the first participant was enrolled.This clinical trial investigates the potential benefits of Gum Arabic (GA) on kidney function in patients with End-Stage Renal Disease (ESRD) who are on dialysis. GA, a natural substance derived from Acacia trees, is known for its use in traditional medicine and is recognized for its safety. It contains beneficial minerals and has been used in various health conditions, including kidney disease. This study seeks to determine if GA can help improve the remaining kidney function in these patients, which could potentially improve their overall health and quality of life. Participants in the study will receive GA as part of their treatment regimen while continuing with their regular dialysis. The study will monitor how GA affects kidney function by measuring specific health markers over time. These include levels of certain substances in the blood that indicate kidney health. The trial aims to provide more evidence on whether GA can be a helpful addition to the treatment of kidney disease, with careful monitoring to assess its safety and effectiveness. The findings could lead to improved management strategies for patients on dialysis.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.40 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: To be eligible to participate in this trial, an individual must meet all the following criteria: 1. Men and women ≥18 years of age with diagnosed ESRD and prescribed regular dialysis at least once a week, weekly at least for past two weeks. 2. For past two weeks including women of childbearing potential who are currently adopting any method of contraception or have completed the family and undergone sterilization procedures and women of non-childbearing potential. 3. Patients with residual renal function - Patients who produce a minimum of 200 ml of urine during a full day of collection (A full day collection: the patient discards the first urine sample on the day of collection then collects all urine for the entire day and night and collects the first urine sample of the next day) r on a non-dialysis long break day. 4. Able and willing to complete the whole period of the study (maximum of 266 days from enrolment). 5. With the ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and be able to comply with the requirements of the protocol. Exclusion Criteria: 1. Women of childbearing potential not adopting any methods of contraception, have not undergone sterilization. 2. Women Pregnant or lactating 3. Patients who plan to conceive (or for their partners to conceive) within 12 months of randomization. 4. Patient presenting with serum K+levels ≥ 6mmol/L based on the last two reports as per medical records. 5. Patients who produce less than 200 ml of urine during 24 hours urine collection at baseline assessment. 6. Peritoneal dialysis. 7. Kidney transplant or booked for a live transplant within 259 days of randomization. 8. Patients gaining \>4 kg between dialysis sessions in the past 2 weeks. 9. People with known allergies to quillaja bark or similar tree bark. 10. Patients are already participating in another clinical trial (excluding COVID-19 vaccine or COVID-19 drug trials). 11. Patients on immunosuppression for kidney transplant. Additional exclusion criteria for follow-up visits. 1. Patient informs of pregnancy. 2. Severe adverse reaction to the interventional product.
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location