Condition category
Pregnancy and Childbirth
Date applied
24/12/2014
Date assigned
21/01/2015
Last edited
30/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Channa striatus (Haruan) is a fresh water fish that has been eaten for decades by women that have just given birth to aid wound healing after a caesarian. There have been extensive studies done on the biomedical properties of this extract (that is, how it works in the body) but there has not been, to date, any clinical trials to test if it really does help wounds to heal. The aim of this study is to get scientific evidences to substantiate the claims.

Who can participate?
Healthy women aged 18-40 who have just had their first baby by caesarian section.

What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 are given 500mg of channa striatus extract a day for six weeks after their caesarian section. Those in group 2 are given 500mg maltodextrin (a placebo, or dummy pill) a day for six weeks after their caesarian section. Each participant then takes part in a number of assessments to measure, amongst other things, the amount of pain they are feeling, how well their wound is healing and how satisfied they are with the treatment 3 days after their operation and then after two weeks, four weeks and six weeks.

What are the possible benefits and risks of participating?
All study procedures are free to participants and they benefit from information about their medical condition. There are no possible risks to taking part in the study.

Where is the study run from?
Hospital University of Science, Malaysia (Malaysia)

When is the study starting and how long is it expected to run for?
March 2011 to March 2014

Who is funding the study?
University of Science, Malaysia (Malaysia)

Who is the main contact?
Professor Azidah Abdul Kadir

Trial website

Contact information

Type

Scientific

Primary contact

Dr Azidah Abdul Kadir

ORCID ID

Contact details

Department of Family Medicine
School of Medical Sciences
Health Campus
Universiti Sains Malaysia
16150
Kubang Kerian
16150
Malaysia

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The effect of oral channa striatus extract on post lower segment caesarian section (LSCS) women: a randomized, double-blind, placebo-controlled study

Acronym

Study hypothesis

1. There is significant reduction of post-operative pain in the Channa striatus group compared to placebo group
2. There is significant improvement of wound healing based on WES, VAS and patient’s satisfaction score in the Channa striatus group compared to placebo group
3. There is no significant difference in safety profile between Channa striatus group and placebo group
4. There is significant difference in the uterine involution and blood supply to the uterus in terms ultrasound measured between Channa striatus group and placebo group
5. There is significant difference in the wound healing measured by mean resistive index (RI) and pulsatility index (PI) and of the artery of the superficial skin wound between channa striatus group and placebo group

Ethics approval

Ethics Research Committee (Human) of Universiti Sains Malaysia (with the permission of Director of Hospital Universiti Sains Malaysia), 31/12/2009, ref: USMKK/PPP/JEPeM [220.3.(04)]

Study design

Randomized double-blind placebo-controlled study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

To assess the effect of oral channa striatus extract on post lower segment caesarian women in terms of post operative pain, wound healing, safety profile and uterine involution.

Intervention

The patients were randomized to two groups in the ratio of 1:1 using computer develop generation numbers in the block of four. The treatment group was prescribed 500 mg (2 capsules) per day of freeze dried channa striatus extract while the placebo group was given 500 mg (2 capsules) per day of maltodextrin. Both arms took the medication for 6 weeks.

Intervention type

Supplement

Phase

Drug names

Primary outcome measures

1. Post-operative pain score
2. Wound healing based on:
2.1. Wound Evaluation Scale (WES)
2.2. Visual Analogue Scale (VAS)
2.3. Patient’s satisfaction score (PSS)
3. Safety profile based on Renal Function Test (RFT), Liver Function Test (LFT) and Full Blood Count (FBC)
4. Mean anteroposterior measurement of the uterus in longitudinal and oblique transverse planes
5. Mean resistive index (RI) and pulsatility index (PI) of the uterine artery
6. Mean resistive index (RI) and pulsatility index (PI) and of the artery of the superficial skin wound

Measured at baseline (day 3), two weeks, four weeks and six weeks post-operatively.

Secondary outcome measures

N/A

Overall trial start date

15/03/2011

Overall trial end date

14/03/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age between 18 and 40 years
2. No present active medical, surgical and gynecological problems
3. First LSCS (elective or emergency)

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

84

Participant exclusion criteria

1. Taking any form of herbal extract in the last 3 months before study entry and during the study period
2. History of drug or alcohol abuse.
3. Taking fresh channa striatus during study period
4. Patient taking warfarin or heparin
5. Clinical relevant cardiovascular, gastrointestinal, hepatic, neurologic, endocrine, haematologic, connective tissue disease or other major systemic diseases that would influence the interpretation of results
6. Patients with medical disorder requiring steroid or immunosuppressive therapy
7. Patient with chronic cough or other condition which may cause a rise in intra-abdominal pressure
8. Presence of any congenital anterior abdominal wall defects
9. Mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study.
10. Evidence of uncooperative attitude, including poor compliance including inability to attend follow-up visit

Recruitment start date

15/03/2011

Recruitment end date

31/01/2013

Locations

Countries of recruitment

Malaysia

Trial participating centre

Hospital University of Science, Malaysia
Kubang Kerian
15200
Malaysia

Sponsor information

Organisation

University of Science, Malaysia

Sponsor details

Department of Family Medicine
School of Medical Sciences
Health Campus
Kubang Kerian
16150
Malaysia

Sponsor type

University/education

Website

Funders

Funder type

University/education

Funder name

University of Science, Malaysia

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/26222158

Publication citations

Additional files

Editorial Notes