Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens - Full Text View

Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

This study is currently recruiting participants.
Verified by National Research Institute of Tuberculosis and Lung Disease, Iran, September 2008

Sponsored by:	National Research Institute of Tuberculosis and Lung Disease, Iran
Information provided by:	National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier:	NCT00537875

Purpose

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.

Condition	Intervention
Nausea Vomiting	Dietary Supplement: Ginger Dietary Supplement: Placebo

MedlinePlus related topics:

Dietary Supplements Nausea and Vomiting Tuberculosis

Drug Information available for:

Cisplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Investigator), Crossover Assignment

Official Title:	Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

Further study details as provided by National Research Institute of Tuberculosis and Lung Disease, Iran:

Primary Outcome Measures:

Nausea, Vomiting [ Time Frame: 3 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	September 2007
Estimated Study Completion Date:	September 2009
Estimated Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator	Dietary Supplement: Ginger Capsule, 1000 mg, BID, 3 days
2: Placebo Comparator	Dietary Supplement: Placebo Capsule, 1000 mg, BID, 3 days

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00537875

Contacts


Contact: Somayeh Amini, Pharm.D.	98-912-105-0618	sa_am1361@yahoo.com

Locations


Iran, Islamic Republic of
	National Research Institute of Tuberculosis and Lung Disease (NRITLD)	Recruiting
	Tehran, Iran, Islamic Republic of, P.O: 19575/154
	Sub-Investigator: Fanak Fahimi, BCPS

Sponsors and Collaborators

National Research Institute of Tuberculosis and Lung Disease, Iran

Investigators


Principal Investigator:	Shadi Baniasadi, Ph.D.	National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences

More Information

Responsible Party:	National Research Institute of Tuberculosis and Lung Disease ( Dr. Baniasadi )
Study ID Numbers:	5336-18-06-86
First Received:	October 1, 2007
Last Updated:	September 16, 2008
ClinicalTrials.gov Identifier:	NCT00537875
Health Authority:	Iran: Ministry of Health

Study placed in the following topic categories:

Signs and Symptoms

Vomiting

Cisplatin

Signs and Symptoms, Digestive

Nausea

ClinicalTrials.gov processed this record on October 24, 2008