Chronic Kidney Diseases
Conditions
Brief summary
The aim of the study is to evaluate the impact of gum acacia on serum levels of protein-bound uremic toxins (indoxyl sulfate and p-cresyl sulfate).In addition to the evaluation of its effect on metabolic profile and disease progression in chronic kidney disease patients.
Detailed description
1. Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University. 2. All participants should agree to take part in this clinical study and will provide informed consent. 3. Eighty chronic kidney disease patients,will be recruited from the Kidney and Urology Center (KUC) and Alexandria main university hospital (AMUH). The 80 participants will be randomly assigned into 2 arms. Control arm (n=40): will be treated with standard treatment without any herbal intervention. Intervention arm (n=40): will be treated with standard treatment in addition to gum acacia sachets. Each sachet contains 25 g of gum acacia powder to be taken on daily-basis for 3 months. 4. All patients will be submitted to : * Full patient history and clinical examination. * Blood withdrawal in order to conduct lab work. 5. Patients demographic data will be recorded with respect to age, weight and other co-morbidities. 6. Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results. 7. Results, conclusion, discussion and recommendations will be given.
Interventions
DIETARY_SUPPLEMENTGum acacia
25 grams of gum acacia powder is administered on daily-basis
Sponsors
Alexandria University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Non-hemodialysis CKD patients (Stage III -V) * Age: above 18 years
Exclusion criteria
* Hemodialysis patients * Pregnancy & lactation * Patients recently treated with antibiotic regimen (2 - 4 weeks) * Malignancy * Inflammatory bowel disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins | 3 months | indoxyl sulfate, p-cresyl sulfate sulfate) |
| Mean change from baseline values of serum electrolytes levels | 3 months | Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus |
| Mean change from baseline values of serum albumin levels | 3 months | Suggested parameters include: serum albumin |
| Mean change from baseline values of renal profile of chronic kidney disease patients. | 3 months | Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR) |
| Mean change from baseline values of complete blood picture | 3 months | Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system | 3 months | Patients will be contacted on a regular basis to monitor adverse effects |
| Effect of gum acacia on disease progression | 3 months | expressed in terms of loss 50% in glomerular filtration rate and need for renal replacement therapy loss 50% in glomerular filtration rate and need for renal replacement therapy |
Countries
Egypt
Outcome results
None listed