Channa Striatus Extract on Albumin and Hs-CRP ESRD
Condition: End-Stage Renal Disease; Inflammation
MeSH terms: Kidney Diseases; Kidney Failure, Chronic; Inflammation
Study type: Interventional
Phase: Phase 4

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
    

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.
    

Intervention name(s): Channa Striatus extract; Maltodextrin
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Channa Striatus extract given with a dose of 500 mg three-times-daily for each patient; Maltodextrin given three-times-daily for each patient
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: end-stage renal disease; albumin; hs-crp; randomized controlled trial; channa striatus