Evaluation of the Effect of Zingiber Officinalis on Nause... | NCT00537875

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

NCT00537875

Sponsor

National Research Institute of Tuberculosis and Lung Disease, Iran

Status

Completed

Last Update Posted

Oct 8, 2015Estimated

Enrollment

36Actual

Phase

Not Applicable

Conditions

Nausea
Vomiting

Interventions

Ginger
Placebo

Countries

Iran

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Oct 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 1, 2007

First Submission Date that Met QC Criteria

Oct 1, 2007

First Posted Date

Oct 2, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 7, 2015

Last Update Posted Date

Oct 8, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Shadi Baniasadi, associate professor, National Research Institute of Tuberculosis and Lung Disease, IranPrincipal Investigator

Lead Sponsor

National Research Institute of Tuberculosis and Lung Disease, IranOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

36Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator		Dietary Supplement: Ginger
2	Placebo Comparator		Dietary Supplement: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Ginger	Dietary Supplement	Capsule, 1000 mg, BID, 3 days	1
Placebo

Measure	Description	Time Frame
Nausea, Vomiting		3 days

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
National Research Institute of Tuberculosis and Lung Disease (NRITLD)		Tehran		P.O: 19575/154	Iran

Condition Browse Module

MeSH Terms

ID	Term
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000713927	ginger extract

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided