NCT01733212

Brief Summary

SPECIFIC AIMS

  • Assess risk factors for nausea and vomiting in c-section patients undergoing regional anesthesia
  • Quantify the incidence of nausea and vomiting intraoperatively and postoperatively in the ginger and placebo groups.
  • Quantify post-operative analgesia and pruritus in the ginger and placebo groups
  • Quantify patient satisfaction of the ginger and placebo groups
  • Assess patient expectation of ginger on post-op day three

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
239

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jun 2010

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

November 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 26, 2012

Completed
5.5 years until next milestone

Results Posted

Study results publicly available

May 11, 2018

Completed
Last Updated

September 10, 2021

Status Verified

August 1, 2018

Enrollment Period

1.1 years

First QC Date

November 20, 2012

Results QC Date

April 30, 2013

Last Update Submit

September 8, 2021

Conditions

NauseaVomiting

Keywords

NauseaVomitingCesaraenGingercesarean section

Outcome Measures

Primary Outcomes (1)

  • Occurrence of Intra-operative and Post-operative Vomiting

    Participants who had intra-operative and post-operative vomiting were identified and compared between the two groups.

    During surgery (1 hour) and thru 72 hours after surgery

Study Arms (2)

Ginger

EXPERIMENTAL

2 gm powder of ginger filled in a capsule

Drug: Ginger

Placebo

PLACEBO COMPARATOR

2 gm of placebo pill (A capsule)

Drug: Placebo Oral Tablet

Interventions

GingerDRUG

Ginger is an herb. The rhizome (underground stem) is used as a spice and also as a medicine. It can be used fresh, dried and powdered, or as a juice or oil. Two capsules (1g each) of dry powdered ginger are given, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.

Also known as: Zingiber Officinale
Ginger
Placebo Oral TabletDRUG

Two capsules (1g each) of placebo, one capsule a half-hour before induction of anesthesia and the second 2h after surgery.

Placebo

Eligibility Criteria

Age20 Years - 49 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy (i.e., ASA I, or II) patients presenting for planned c-section at New York Methodist Hospital
  • Signed informed consent

You may not qualify if:

  • They are unable or unwilling to take part in the study
  • They have a history of an allergy to any medications used including ginger
  • They have had any gastrointestinal surgery on the stomach, small intestine, or gall bladder.
  • They have any history of bleeding disorder, (i.e., Hemophilia A/B, ITP, etc.)
  • They have a contraindication to intrathecal or epidural anesthesia. ( i.e., Arnold- Chiari malformation, etc.)
  • They are unable to understand instructions or questions related to study
  • ASA III or IV patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (2)

  • Griffiths JD, Gyte GM, Popham PA, Williams K, Paranjothy S, Broughton HK, Brown HC, Thomas J. Interventions for preventing nausea and vomiting in women undergoing regional anaesthesia for caesarean section. Cochrane Database Syst Rev. 2021 May 18;5(5):CD007579. doi: 10.1002/14651858.CD007579.pub3.

    PMID: 34002866DERIVED

  • Kalava A, Darji SJ, Kalstein A, Yarmush JM, SchianodiCola J, Weinberg J. Efficacy of ginger on intraoperative and postoperative nausea and vomiting in elective cesarean section patients. Eur J Obstet Gynecol Reprod Biol. 2013 Jul;169(2):184-8. doi: 10.1016/j.ejogrb.2013.02.014. Epub 2013 Mar 17.

    PMID: 23510951DERIVED

MeSH Terms

Conditions

NauseaVomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Sandip Darji
Organization
New York Methodist Hospital
darji_sandip2005@yahoo.com
718/780-3779

Study Officials

  • Jonathan Weinberg, MD

    New York Presbyterian Brooklyn Methodist Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending Physician, Program Director (Anesthesiology)

Study Record Dates

First Submitted

November 20, 2012

First Posted

November 26, 2012

Study Start

June 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

September 10, 2021

Results First Posted

May 11, 2018

Record last verified: 2018-08

Locations

US(1)