Channa Striatus Extract on Albumin and Hs-CRP ESRD

NCT05614362 | Completed Phase 4 DMC

• 1 other identifier: CStriatusAlbHsCRP
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

End-Stage Renal Disease; Inflammation

Keywords

end-stage renal disease; albumin; hs-crp; randomized controlled trial; channa striatus

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Channa striatus extract

EXPERIMENTAL

Channa striatus group was given 3x1 500mg dose of Channa striatus for 21 days

Dietary Supplement: Channa Striatus extract

Placebo

PLACEBO COMPARATOR

Placebo group was given 3x1 dose of maltodextrin for 21 days

Dietary Supplement: Maltodextrin

Interventions

Channa Striatus extract DIETARY_SUPPLEMENT

Channa Striatus extract given with a dose of 500 mg three-times-daily for each patient

Channa striatus extract

Maltodextrin DIETARY_SUPPLEMENT

Maltodextrin given three-times-daily for each patient

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ESRD patient
• Undergoing HD or CAPD

You may not qualify if:

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

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Moewardi General Hospital

Surakarta, Middle Java, Indonesia

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Inflammation

Interventions

maltodextrin

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 20, 2022
• First Posted: November 14, 2022
• Study Start: January 1, 2021
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: November 14, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)