Post Cesarean Section PatientPhase 4NCT02809027
Efficacy of Ginger in the Prevention of Abdominal Distention in Post Cesarean Section Patient
A Phase 4 study testing Ginger in people with Post Cesarean Section Patient, run by Chulalongkorn University.
Trial summary
The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Post Cesarean Section Patient
- What is being tested?
- Ginger
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2016to 30 Jun 2017
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Post cesarean section women
Who cannot join
- 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
About this study
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
The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.
- Conditions
- Post Cesarean Section Patient
- Being tested
- Ginger, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GingerDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Ginger | Active comparator | Ginger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days Receives: Drug: Ginger |
| Placebo | Sham comparator | Placebo capsule, oral form, 2 capsules 3 time after meal for 3 days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence abdominal distention as measured by diary chart (history taking and examination)
Measured: 72 hours
Secondary outcomes (6)
Maternal satisfaction as measured by questionaire
Measured: 72 hours
Quality of life as measured by questionaire
Measured: 72 hours
nausea vomiting as measured by questionaire
Measured: 72 hours
first time to pass flatus/feces as measured by diary chart
Measured: 72 hours
number of carminative drug use as measured by questionaire
Measured: 72 hours
side effect as measured by questionaire
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2016 (estimated)
- Study start1 Jun 2016
- Primary completion30 Jun 2017
- Study completion30 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Post Cesarean Section PatientStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 178 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vorapong Phupong, Chulalongkorn University
- Investigators
- Vorapong Phupong, M.D., Study director, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02809027
- Sponsor's protocol ID
- 114/59
- Status last verified
- Jul 2020
- First submitted
- 16 Jun 2016
- Last updated
- 15 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 20119556Chaiyakunapruk 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.
PubMed 16389016O'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.
PubMed 9821826Ushiroyama 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.
PubMed 17436360Gibstein 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.
PubMed 4937581Hu 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.
PubMed 21218090
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02809027
- Acronym / sponsor ID
- 114/59
- Conditions
- Post Cesarean Section Patient
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 178 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Jun 2016
- Primary completion
- 30 Jun 2017 (actual)
- Study completion
- 30 Jun 2017 (actual)
- First posted
- 22 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine ginger is effective in the prevention of abdominal distention in post Cesarean section patient.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ginger | Active comparator | Drug: GingerGinger capsule (500 mg), oral form, 2 capsules 3 time after meal for 3 days |
| Placebo | Sham comparator | Drug: PlaceboPlacebo capsule, oral form, 2 capsules 3 time after meal for 3 days |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Post cesarean section women
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ginger | Drug | Ginger |
| Placebo | Drug | Placebo |
Primary outcome
incidence abdominal distention as measured by diary chart (history taking and examination)
Time frame: 72 hours
6 secondary outcomes
Maternal satisfaction as measured by questionaire
Time frame: 72 hours
Quality of life as measured by questionaire
Time frame: 72 hours
nausea vomiting as measured by questionaire
Time frame: 72 hours
first time to pass flatus/feces as measured by diary chart
Time frame: 72 hours
number of carminative drug use as measured by questionaire
Time frame: 72 hours
side effect as measured by questionaire
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2020.
- Background: PubMed 20119556Carroll 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.
- Background: PubMed 16389016Chaiyakunapruk 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.
- Background: PubMed 9821826O'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.
- Background: PubMed 17436360Ushiroyama 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 publication: PubMed 4937581Gibstein 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 publication: PubMed 21218090Hu 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.
- Individual participant dataSharing planned: Undecided
Related trials for Post Cesarean Section Patient
Not yet recruiting
The Mepilex Cesarean Delivery Trial / MEPIDEL
Surgical Site Infection
Recruiting
Reflexology Hand Massage After Cesarean Section
Cesarean Section, Anxiety
Not yet recruitingPhase 4
Effect of Preoperative Intranasal Dexmedetomidine on Incidence of Intraoperative Shivering in Patients Undergoing Cesarean Section Under Spinal Anesthesia
Shivering, Hypothermia
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ERAS Protocol for Cesarean Delivery in Women With Placenta Previa
Placenta Previa
Not yet recruitingPhase 4
Dexamethasone Versus Ondansetron for Preventing Post-Spinal Hypotension in Preeclampsia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vorapong Phupong, M.D. study director
Chulalongkorn University
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ginger in people with Post Cesarean Section Patient, run by Chulalongkorn University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence abdominal distention as measured by diary chart (history taking and examination) (time frame: 72 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02809027, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2020.