Channa Striatus Extract on Albumin and Hs-CRP ESRD

The Effect of Channa Striatus Extract on Serum Albumin and High Sensitive C-Reactive Protein in End-Stage Renal Disease Patients

This study is a randomised, double blind, placebo-controlled study in patients with ESRD on HD or CAPD based RRTs at Moewardi General Hospital in Surakarta, Indonesia from January to March 2021. Subjects were randomized to either a Channa striata or a placebo group and were given a three times daily dosage of 500 mg of Channa striatus extract or 500 mg maltodextrin, respectively for 21 days. Serum albumin and hs-CRP were measured at the baseline, and at the end of the study

Study Overview

• Status: Completed
• Conditions: Inflammation; End-Stage Renal Disease
• Intervention / Treatment: Dietary supplement: Channa Striatus extract; Dietary supplement: Maltodextrin

Detailed Description

Study design This research was a randomized, double blinded, 2-arm parallel comparative study of CS extract vs placebo. This was conducted at the Department of Kidney and Hypertension, Moewardi General Hospital Surakarta from January 2021 - March 2021. The researcher has obtained an ethical clearance from the local ethics commission for basic/clinical research at Moewardi General Hospital, Surakarta.

Patient selection The population in this study were ESRD patients aged between 18 and 60 years old who underwent HD and CAPD at Moewardi General Hospital, Surakarta and agreed to being included in this study. Patients with history of malignancies, autoimmune disease, and active infection all were excluded. Patients who had taken any form albumin, herbal supplementation, antioxidant, steroid, immunosuppressive or heparin medication were also excluded. Sample selection was done by consecutive sampling to all eligible ESRD patients. The samples in this study would be divided into 2 groups; treatment group and control group, each had the same proportion of HD and CAPD patient.

Randomization and blinding The participants were randomized into 2 equal size groups which were the CS and placebo group. Participants were numbered sequentially following time of participation, and the type of RRT received. This separation of numbering according to RRT was performed to ensure an equal proportion of RRT received in both groups. A randomization list was generated using Random Allocation Software and subject numbers were allocated with 1:1 ratio, separately according to the type of RRT received. Blinding of participants and attending physicians were achieved by using identical capsules of placebo and CS extract.

The intervention The CS extract was obtained from ONOIWA® capsules (PT. Natura Nuswantara Nirmala, Tangerang, Indonesia) and purchased from a retail drug store. Each capsule contained pure 500 mg CS extract powder. The placebo used was 500 mg maltodextrin powder encapsulated in the same capsule color of the CS extract capsule. The placebo was prepared in Pharmacy Department of Moewardi General Hospital, and pre-purchased from a commercial drug store. Both of the groups consumed the extract of the placebo, with a dose of three times a day for 21 days.

Study visit and endpoint The venous blood samples for hs-CRP and albumin were collected before the administration of intervention, and at day 21. All of the tubes were then sent to the Department of Clinical Pathology at Moewardi General Hospital for the blood analysis to be performed. All social demographic feature of the patients were collected at baseline, including gender, age, type and length of RRT treatment. All of the patients were then monitored at each weekly visit to examine their clinical status and will be drop-outed when clinical deterioration occurred.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Middle Java
    • Surakarta, Middle Java, Indonesia
      • Moewardi General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• ESRD patient
• Undergoing HD or CAPD

Exclusion Criteria:

• History of malignancy, autoimmune disease, active infection
• Supplementation of albumin, herbal, antioxidant, steroid, immunosuppresive, heparin

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Channa striatus extract; Channa striatus group was given 3x1 500mg dose of Channa striatus for 21 days	Dietary supplement: Channa Striatus extract; Channa Striatus extract given with a dose of 500 mg three-times-daily for each patient
Placebo Comparator: Placebo; Placebo group was given 3x1 dose of maltodextrin for 21 days	Dietary supplement: Maltodextrin; Maltodextrin given three-times-daily for each patient

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of concentration of serum albumin	Serum albumin is measured by laboratory assessment	21 days post-intervention
Change of concentration of serum hs-CRP	hs-CRP is measured by laboratory assessment	21 days post-intervention

Collaborators and Investigators

• Sponsor: Universitas Sebelas Maret

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: October 20, 2022
• First Submitted That Met QC Criteria: November 6, 2022
• First Posted (Actual): November 14, 2022

Study Record Updates

• Last Update Posted (Actual): November 14, 2022
• Last Update Submitted That Met QC Criteria: November 6, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: randomized controlled trial; albumin; end-stage renal disease; hs-crp; channa striatus
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Inflammation; Kidney Failure, Chronic
• Other Study ID Numbers: CStriatusAlbHsCRP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No