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NCT00537875 Clinical Trial

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

Nausea Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00537875
Other study ID # 5336-18-06-86
Secondary ID
Status Completed
Phase N/A
First received October 1, 2007
Last updated October 7, 2015
Start date September 2007
Est. completion date September 2009

Study information
Verified date October 2015
Source National Research Institute of Tuberculosis and Lung Disease, Iran
Contact n/a
Is FDA regulated No
Health authority Iran: Ministry of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 36
Est. completion date September 2009
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Ginger
Capsule, 1000 mg, BID, 3 days
• Placebo
Capsule, 1000 mg, BID, 3 days

Locations
Country Name City State
Iran, Islamic Republic of National Research Institute of Tuberculosis and Lung Disease (NRITLD) Tehran

Sponsors (1)
Lead Sponsor Collaborator
National Research Institute of Tuberculosis and Lung Disease, Iran

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Nausea, Vomiting 3 days No
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