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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.
Ethical committee approval has been obtained from Ethics committee of Faculty of Medicine, Alexandria University.
All participants should agree to take part in this clinical study and will provide informed consent.
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.
All patients will be submitted to :
Patients demographic data will be recorded with respect to age, weight and other co-morbidities.
Statistical tests appropriate to the study design will be conducted to evaluate the significance of the results.
Results, conclusion, discussion and recommendations will be given.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients receiving gum acacia | Active Comparator | Group one will receive gum acacia extract as an add-on therapy on daily basis |
|
| Patients receiving no intervention | No Intervention | Group two will not receive add-on therapy; they will receive standard care only. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gum acacia | Dietary Supplement | 25 grams of gum acacia powder is administered on daily-basis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean change from baseline values of renal profile of chronic kidney disease patients. | Suggested parameters include: urea, serum creatinine, uric acid, urinary Albumin to creatinine (ACR) | 3 months |
| Percentage change from baseline scores of serum levels of suggested gut-derived protein bound uremic toxins | indoxyl sulfate, p-cresyl sulfate sulfate) | 3 months |
| Mean change from baseline values of complete blood picture | Suggested parameters include: Haemoglobin (Hb) , White blood cells count (WCC), Platelets count (PLT) | 3 months |
| Mean change from baseline values of serum electrolytes levels | Suggested parameters include: serum sodium, serum potassium, serum calcium and serum phosphorus | 3 months |
| Mean change from baseline values of serum albumin levels | Suggested parameters include: serum albumin | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Effect of gum acacia on disease progression | 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 | 3 months |
| Adverse effects of gum acacia will be also addressed through adverse effect monitoring system. monitoring system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Merna M. AbouKhatwa, BSc | Faculty of Pharmacy, Alexandria University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kidney and Urology Center (KUC) | Alexandria | Egypt |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D006170 | Gum Arabic |
| ID | Term |
|---|---|
| D053149 | Plant Gums |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
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Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
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Patients will be contacted on a regular basis to monitor adverse effects |
| 3 months |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011134 |
| Polysaccharides |
| D002241 | Carbohydrates |
| D053147 | Plant Exudates |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |