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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2009 by National Research Institute of Tuberculosis and Lung Disease, Iran.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier:
NCT00537875
First received: October 1, 2007
Last updated: March 30, 2009
Last verified: March 2009
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens

Resource links provided by NLM:


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
Active Comparator: 1 Dietary Supplement: Ginger
Capsule, 1000 mg, BID, 3 days
Placebo Comparator: 2 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Iran, Islamic Republic of
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
Tehran, Iran, Islamic Republic of, P.O: 19575/154
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

No publications provided

Responsible Party: Dr. Baniasadi, National Research Institute of Tuberculosis and Lung Disease
ClinicalTrials.gov Identifier: NCT00537875     History of Changes
Other Study ID Numbers: 5336-18-06-86
Study First Received: October 1, 2007
Last Updated: March 30, 2009
Health Authority: Iran: Ministry of Health

Additional relevant MeSH terms:
Nausea
Vomiting
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014