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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00537875
First Posted: October 2, 2007
Last Update Posted: October 8, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Shadi Baniasadi, National Research Institute of Tuberculosis and Lung Disease, Iran
  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 (Participant, 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 Shadi Baniasadi, National Research Institute of Tuberculosis and Lung Disease, Iran:

Primary Outcome Measures:
  • Nausea, Vomiting [ Time Frame: 3 days ]

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: September 2009
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Shadi Baniasadi, associate professor, National Research Institute of Tuberculosis and Lung Disease, Iran
ClinicalTrials.gov Identifier: NCT00537875     History of Changes
Other Study ID Numbers: 5336-18-06-86
First Submitted: October 1, 2007
First Posted: October 2, 2007
Last Update Posted: October 8, 2015
Last Verified: October 2015

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