Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05614362 |
| Other study ID # |
CStriatusAlbHsCRP |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2021 |
| Est. completion date |
March 1, 2021 |
Study information
| Verified date |
November 2022 |
| Source |
Universitas Sebelas Maret |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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.
