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

Primary Purpose

Nausea, Vomiting

Status
Completed
Phase
Not Applicable
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Ginger
Placebo
Sponsored by
National Research Institute of Tuberculosis and Lung Disease, Iran
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Nausea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • National Research Institute of Tuberculosis and Lung Disease (NRITLD)

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Nausea, Vomiting

Secondary Outcome Measures

Full Information

First Posted
October 1, 2007
Last Updated
October 7, 2015
Sponsor
National Research Institute of Tuberculosis and Lung Disease, Iran
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1. Study Identification

Unique Protocol Identification Number
NCT00537875
Brief Title
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens
Official Title
Evaluation of the Effect of Zingiber Officinalis on Nausea and Vomiting in Patients Receiving Cisplatin Based Regimens
Study Type
Interventional

2. Study Status

Record Verification Date
October 2015
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Research Institute of Tuberculosis and Lung Disease, Iran

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Ginger
Intervention Description
Capsule, 1000 mg, BID, 3 days
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Capsule, 1000 mg, BID, 3 days
Primary Outcome Measure Information:
Title
Nausea, Vomiting
Time Frame
3 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shadi Baniasadi, Ph.D.
Organizational Affiliation
National Research Institute of Tuberculosis and Lung Disease (NRITLD)-Shaheed Beheshti University of Medical Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Research Institute of Tuberculosis and Lung Disease (NRITLD)
City
Tehran
ZIP/Postal Code
P.O: 19575/154
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

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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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