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

N

National Research Institute of Tuberculosis and Lung Disease, Iran

Status

Completed

Conditions

Vomiting
Nausea

Treatments

Dietary Supplement: Placebo
Dietary Supplement: Ginger

Study type

Interventional

Funder types

Other

Identifiers

NCT00537875
5336-18-06-86

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No 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.

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Crossover Assignment

Masking

Double Blind

36 participants in 2 patient groups, including a placebo group

1
Active Comparator group
Treatment:
Dietary Supplement: Ginger
2
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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