A Randomized Double Blind Placebo Controlled Trial of Ginger to Reduce Symptoms of Nausea and Vomiting Associated with Bowel Preparation Prior to Colonoscopy

Our study population will consist of 100 subjects who present for routine colonoscopy at Rush University Gastroenterologists outpatient clinic.  

All subjects who provide informed consent will be enrolled. At this time, participants will complete a questionnaire that details demographic information, symptoms of abdominal pain and discomfort to evaluate for irritable bowel syndrome (Rome II criteria), past medical history and past surgical history. Appropriate data will be recorded into a security-protected database. Overall, it is estimated that it will take the subjects 5 to 10 minutes to complete the questionnaire and they will be able to do so during their office visit. 

Afterward, the subjects will be randomized to PEG-ELS (bowel prep) plus ginger or placebo. Subjects will be given standard instructions on bowel preparation completion as per routine prior to colonoscopy. One hour prior to beginning their bowel preparation, the day before the colonoscopy, subjects will ingest either two 550 mg ginger capsules or two identical looking placebo capsules. All subjects will return for their scheduled colonoscopy visit. 

Prior to their procedure, subjects will fill out questionnaires including the Rhodes Index of Nausea, Vomiting and Retching to assess symptoms of nausea and vomiting experienced during their bowel preparation as well as a questionnaire assessing their compliance and willingness to repeat the bowel preparation. The quality of bowel cleansing will be graded at the end of the procedure by the endoscopist according to a previously described scale with ratings from excellent to poor. 

Colonoscopy will be performed in the outpatient endoscopy area:
Suite 339
Rush Professional Office Building
Rush University Medical Center
Chicago, Illinois.

To be eligible for the study, subjects must:

• Be willing and able to provide informed consent
• Be over the age of 18
• Have colorectal cancer screening or survelliance, positive fecal occult blood test or anemia as the indication for their colonoscopy