NCT00537875

Brief Summary

The purpose of this study is to determine whether powdered ginger root (encapsulated ginger) is effective for reducing the frequency, duration and severity of both acute and delayed nausea and vomiting.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable

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

September 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 2, 2007

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2008

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

October 8, 2015

Status Verified

October 1, 2015

Enrollment Period

1 year

First QC Date

October 1, 2007

Last Update Submit

October 7, 2015

Conditions

NauseaVomiting

Outcome Measures

Primary Outcomes (1)

  • Nausea, Vomiting

    3 days

Study Arms (2)

1

ACTIVE COMPARATOR
Dietary Supplement: Ginger

2

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

GingerDIETARY_SUPPLEMENT

Capsule, 1000 mg, BID, 3 days

1
PlaceboDIETARY_SUPPLEMENT

Capsule, 1000 mg, BID, 3 days

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Must be able to give written informed consent.
  • Have a diagnosis of cancer and currently receiving chemotherapy containing cisplatin (any dose).
  • Scheduled to receive antiemetics: granisetron (kytril), hydrocortisone.
  • Must be able to complete study questionnaires.
  • Must be able to swallow capsules.

You may not qualify if:

  • Have no clinical evidence of current or impending bowel obstruction.
  • Concurrent radiotherapy that is classified as high or intermediate risk of causing emesis.
  • Pregnant or lactating.
  • Patients taking therapeutic doses of coumadin (individuals on low-dose to maintain peripheral or central venous catheters are allowed), aspirin (individuals taking low-dose 80mg aspirin are allowed), or heparin.
  • Patients with a history of a bleeding disorder(s) in past 6 months and those experiencing thrombocytopenia.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Tehran, P.O: 19575/154, Iran

Location

MeSH Terms

Conditions

NauseaVomiting

Interventions

ginger extract

Condition Hierarchy (Ancestors)

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

Study Officials

  • Shadi Baniasadi, Ph.D.

    National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate professor

Study Record Dates

First Submitted

October 1, 2007

First Posted

October 2, 2007

Study Start

September 1, 2007

Primary Completion

September 1, 2008

Study Completion

September 1, 2009

Last Updated

October 8, 2015

Record last verified: 2015-10

Locations

IR(1)