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

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ClinicalTrials.gov Identifier: NCT00537875
Recruitment Status : Completed
First Posted : October 2, 2007
Last Update Posted : October 8, 2015
Sponsor:
Information provided by (Responsible Party):
Shadi Baniasadi, National Research Institute of Tuberculosis and Lung Disease, Iran

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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Dietary Supplement: Ginger Dietary Supplement: Placebo Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
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
Study Start Date : September 2007
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Cisplatin
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: 1 Dietary Supplement: Ginger
Capsule, 1000 mg, BID, 3 days
Placebo Comparator: 2 Dietary Supplement: Placebo
Capsule, 1000 mg, BID, 3 days



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


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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.

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

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 Posted: October 2, 2007    Key Record Dates
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