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The effect of oral channa striatus extract on post lower segment caesarian section (LSCS) wome

Not Applicable
Completed
Conditions
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.
Pregnancy and Childbirth
Registration Number
ISRCTN11960786
Lead Sponsor
niversity of Science, Malaysia
Brief Summary

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

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Female
Target Recruitment
66
Inclusion Criteria

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

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

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<br> 1. Post-operative pain score<br> 2. Wound healing based on:<br> 2.1. Wound Evaluation Scale (WES)<br> 2.2. Visual Analogue Scale (VAS)<br> 2.3. Patient’s satisfaction score (PSS)<br> 3. Safety profile based on Renal Function Test (RFT), Liver Function Test (LFT) and Full Blood Count (FBC)<br> 4. Mean anteroposterior measurement of the uterus in longitudinal and oblique transverse planes<br> 5. Mean resistive index (RI) and pulsatility index (PI) of the uterine artery<br> 6. Mean resistive index (RI) and pulsatility index (PI) and of the artery of the superficial skin wound<br><br> Measured at baseline (day 3), two weeks, four weeks and six weeks post-operatively.<br>
Secondary Outcome Measures
NameTimeMethod
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