Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

July 14, 2020 updated by: Vorapong Phupong, Chulalongkorn University

A Randomized Double-blind Placebo-controlled Trial on the Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient

The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

178

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Post cesarean section women

Exclusion Criteria:

  • allergic to ginger
  • time of cesarean section more than 1 hour
  • perform another operation such as appendectomy, cystectomy
  • former use carminative drugs
  • already have abdominal distention

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ginger
Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days
Drug: Ginger
Sham Comparator: Placebo
Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
incidence abdominal distention as measured by diary chart (history taking and examination)
Time Frame: 72 hours
72 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
Maternal satisfaction as measured by questionaire
Time Frame: 72 hours
72 hours
Quality of life as measured by questionaire
Time Frame: 72 hours
72 hours
nausea vomiting as measured by questionaire
Time Frame: 72 hours
72 hours
first time to pass flatus/feces as measured by diary chart
Time Frame: 72 hours
72 hours
number of carminative drug use as measured by questionaire
Time Frame: 72 hours
72 hours
side effect as measured by questionaire
Time Frame: 72 hours
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chulalongkorn University

Investigators

  • Study Director: Vorapong Phupong, M.D., Chulalongkorn University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Actual)

June 30, 2017

Study Completion (Actual)

June 30, 2017

Study Registration Dates

First Submitted

June 16, 2016

First Submitted That Met QC Criteria

June 18, 2016

First Posted (Estimate)

June 22, 2016

Study Record Updates

Last Update Posted (Actual)

July 15, 2020

Last Update Submitted That Met QC Criteria

July 14, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 114/59

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Post Cesarean Section Patient

Clinical Trials on Placebo

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Estonia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe