Trial Outcomes & Findings for Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients (NCT NCT01733212)

NCT ID: NCT01733212

Last Updated: 2021-09-10

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

239 participants

Primary outcome timeframe

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

Results posted on

2021-09-10

Participant Flow

Enrollment period: June 03, 2010 to April 12, 2011 Location: New York Methodist Hospital, Department of Obstetrics and Gynecology

Participant milestones

Participant milestones
Measure	Ginger 2 gm powder of ginger filled in a capsule	Placebo 2 gm of placebo pill (A capsule)
Overall Study STARTED	116	123
Overall Study COMPLETED	116	123
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Efficacy of Ginger on Intraoperative and Postoperative Nausea and Vomiting in Elective Cesarean Section Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ginger n=116 Participants 2 gm powder of ginger filled in a capsule	Placebo n=123 Participants 2 gm of placebo pill (A capsule)	Total n=239 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	116 Participants n=5 Participants	123 Participants n=7 Participants	239 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	32.8 years STANDARD_DEVIATION 5.3 • n=5 Participants	33.0 years STANDARD_DEVIATION 4.8 • n=7 Participants	32.9 years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	116 Participants n=5 Participants	123 Participants n=7 Participants	239 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	116 participants n=5 Participants	123 participants n=7 Participants	239 participants n=5 Participants

PRIMARY outcome

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

Population: Number of participants who had vomiting in each group is compared to the other group using Chi square test

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

Outcome measures

Outcome measures
Measure	Ginger n=116 Participants 2 gm powder of ginger filled in a capsule	Placebo n=123 Participants 2 gm of placebo pill (A capsule)
Occurrence of Intra-operative and Post-operative Vomiting	30 Participants	45 Participants

Adverse Events

Ginger

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sandip Darji

New York Methodist Hospital

Phone: 718/780-3779

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place