Channa Striatus Extract on Albumin and Hs-CRP ESRD
Primary Purpose
End-Stage Renal Disease, Inflammation
Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
Channa Striatus extract
Maltodextrin
Sponsored by
About this trial
This is an interventional supportive care trial for End-Stage Renal Disease focused on measuring end-stage renal disease, albumin, hs-crp, randomized controlled trial, channa striatus
Eligibility Criteria
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
Sites / Locations
- Moewardi General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Channa striatus extract
Placebo
Arm Description
Channa striatus group was given 3x1 500mg dose of Channa striatus for 21 days
Placebo group was given 3x1 dose of maltodextrin for 21 days
Outcomes
Primary Outcome Measures
Change of concentration of serum albumin
Serum albumin is measured by laboratory assessment
Change of concentration of serum hs-CRP
hs-CRP is measured by laboratory assessment
Secondary Outcome Measures
Full Information
NCT ID
NCT05614362
First Posted
October 20, 2022
Last Updated
November 6, 2022
Sponsor
Universitas Sebelas Maret
1. Study Identification
Unique Protocol Identification Number
NCT05614362
Brief Title
Channa Striatus Extract on Albumin and Hs-CRP ESRD
Official Title
The Effect of Channa Striatus Extract on Serum Albumin and High Sensitive C-Reactive Protein in End-Stage Renal Disease Patients
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universitas Sebelas Maret
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease, Inflammation
Keywords
end-stage renal disease, albumin, hs-crp, randomized controlled trial, channa striatus
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Channa striatus extract
Arm Type
Experimental
Arm Description
Channa striatus group was given 3x1 500mg dose of Channa striatus for 21 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo group was given 3x1 dose of maltodextrin for 21 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Channa Striatus extract
Intervention Description
Channa Striatus extract given with a dose of 500 mg three-times-daily for each patient
Intervention Type
Dietary Supplement
Intervention Name(s)
Maltodextrin
Intervention Description
Maltodextrin given three-times-daily for each patient
Primary Outcome Measure Information:
Title
Change of concentration of serum albumin
Description
Serum albumin is measured by laboratory assessment
Time Frame
21 days post-intervention
Title
Change of concentration of serum hs-CRP
Description
hs-CRP is measured by laboratory assessment
Time Frame
21 days post-intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Moewardi General Hospital
City
Surakarta
State/Province
Middle Java
Country
Indonesia
12. IPD Sharing Statement
Plan to Share IPD
No
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Channa Striatus Extract on Albumin and Hs-CRP ESRD
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