Impact of Gum Acacia on Chronic Kidney Disease Patients

NCT ID: NCT05599399

Last Updated: 2023-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-07-18

Study Completion Date

2023-04-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Chronic Kidney Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Open labelled, prospective, two-arm, parallel group, non-placebo controlled clinical trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Patients receiving gum acacia

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

Group Type ACTIVE_COMPARATOR

Gum acacia

Intervention Type DIETARY_SUPPLEMENT

25 grams of gum acacia powder is administered on daily-basis

Patients receiving no intervention

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Gum acacia

25 grams of gum acacia powder is administered on daily-basis

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexandria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Merna M. AbouKhatwa, BSc

Role: PRINCIPAL_INVESTIGATOR

Faculty of Pharmacy, Alexandria University

Locations

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Kidney and Urology Center (KUC)

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0107213

Identifier Type: -

Identifier Source: org_study_id

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