search
Back to results

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

Primary Purpose

Post Cesarean Section Patient

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Ginger
Placebo
Sponsored by
Chulalongkorn University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Post Cesarean Section Patient

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Sham Comparator

    Arm Label

    Ginger

    Placebo

    Arm Description

    Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days

    Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days

    Outcomes

    Primary Outcome Measures

    incidence abdominal distention as measured by diary chart (history taking and examination)

    Secondary Outcome Measures

    Maternal satisfaction as measured by questionaire
    Quality of life as measured by questionaire
    nausea vomiting as measured by questionaire
    first time to pass flatus/feces as measured by diary chart
    number of carminative drug use as measured by questionaire
    side effect as measured by questionaire

    Full Information

    First Posted
    June 16, 2016
    Last Updated
    July 14, 2020
    Sponsor
    Chulalongkorn University
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT02809027
    Brief Title
    Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
    Official Title
    A Randomized Double-blind Placebo-controlled Trial on the Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2020
    Overall Recruitment Status
    Completed
    Study Start Date
    June 1, 2016 (undefined)
    Primary Completion Date
    June 30, 2017 (Actual)
    Study Completion Date
    June 30, 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chulalongkorn University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Post Cesarean Section Patient

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    178 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ginger
    Arm Type
    Active Comparator
    Arm Description
    Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days
    Arm Title
    Placebo
    Arm Type
    Sham Comparator
    Arm Description
    Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days
    Intervention Type
    Drug
    Intervention Name(s)
    Ginger
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Primary Outcome Measure Information:
    Title
    incidence abdominal distention as measured by diary chart (history taking and examination)
    Time Frame
    72 hours
    Secondary Outcome Measure Information:
    Title
    Maternal satisfaction as measured by questionaire
    Time Frame
    72 hours
    Title
    Quality of life as measured by questionaire
    Time Frame
    72 hours
    Title
    nausea vomiting as measured by questionaire
    Time Frame
    72 hours
    Title
    first time to pass flatus/feces as measured by diary chart
    Time Frame
    72 hours
    Title
    number of carminative drug use as measured by questionaire
    Time Frame
    72 hours
    Title
    side effect as measured by questionaire
    Time Frame
    72 hours

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Vorapong Phupong, M.D.
    Organizational Affiliation
    Chulalongkorn University
    Official's Role
    Study Director

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    20119556
    Citation
    Carroll J, Alavi K. Pathogenesis and management of postoperative ileus. Clin Colon Rectal Surg. 2009 Feb;22(1):47-50. doi: 10.1055/s-0029-1202886.
    Results Reference
    background
    PubMed Identifier
    16389016
    Citation
    Chaiyakunapruk N, Kitikannakorn N, Nathisuwan S, Leeprakobboon K, Leelasettagool C. The efficacy of ginger for the prevention of postoperative nausea and vomiting: a meta-analysis. Am J Obstet Gynecol. 2006 Jan;194(1):95-9. doi: 10.1016/j.ajog.2005.06.046.
    Results Reference
    background
    PubMed Identifier
    9821826
    Citation
    O'Hara M, Kiefer D, Farrell K, Kemper K. A review of 12 commonly used medicinal herbs. Arch Fam Med. 1998 Nov-Dec;7(6):523-36. doi: 10.1001/archfami.7.6.523.
    Results Reference
    background
    PubMed Identifier
    17436360
    Citation
    Ushiroyama T, Sakuma K, Souen H, Nakai G, Morishima S, Yamashita Y, Kamegai H. Xiong-gui-tiao-xue-yin (Kyuki-chouketsu-in), a traditional herbal medicine, stimulates lactation with increase in secretion of prolactin but not oxytocin in the postpartum period. Am J Chin Med. 2007;35(2):195-202. doi: 10.1142/S0192415X07004734.
    Results Reference
    background
    PubMed Identifier
    4937581
    Citation
    Gibstein A, Cooper JJ, Wisot AL, Rosenthal AH. Prevention of postoperative abdominal distention and discomfort with simethicone. Obstet Gynecol. 1971 Sep;38(3):386-90. No abstract available.
    Results Reference
    result
    PubMed Identifier
    21218090
    Citation
    Hu ML, Rayner CK, Wu KL, Chuah SK, Tai WC, Chou YP, Chiu YC, Chiu KW, Hu TH. Effect of ginger on gastric motility and symptoms of functional dyspepsia. World J Gastroenterol. 2011 Jan 7;17(1):105-10. doi: 10.3748/wjg.v17.i1.105.
    Results Reference
    result

    Learn more about this trial

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

    We'll reach out to this number within 24 hrs