Impact of Gum Acacia on Chronic Kidney Disease Patients

Alexandria University

Status: Completed

Conditions: Chronic Kidney Diseases

Treatments: Dietary Supplement: Gum acacia

Study type: Interventional

Funder types: Other

Identifiers

NCT05599399

0107213

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Patients receiving gum acacia

Active Comparator group

Description:

Group one will receive gum acacia extract as an add-on therapy on daily basis

Treatment:

Dietary Supplement: Gum acacia

Patients receiving no intervention

No Intervention group

Description:

Group two will not receive add-on therapy; they will receive standard care only.