A Safety and Efficacy Study of Daikenchuto (TU-100) to Relieve Abdominal Bloating in Female Subjects With Irritable Bowel Syndrome

Exclusion Criteria

• •Have a structural or metabolic disease or condition that affects the GI system, excluding asymptomatic gallstones or uncomplicated gastroesophageal reflux disease, or any medical condition that may be a cause of constipation or diarrhea (e.g., hypothyroid status, poorly controlled diabetes, diabetic neuropathy or autonomic neuropathy)
• •Be taking any medication that, in the opinion of the Principle Investigator (PI), has potential to alter GI transit. A full list of prohibited medications is provided in the protocol. Have history or presence of any chronic lung disease
• •Have presence of hepatic dysfunction, jaundice, or abnormal serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) values exceeding 2.5 x upper limit of normal
• •Currently pregnant or lactating
• •Have a positive urine drug test at screening (subjects who initially test positive will be allowed one retest)
• •Be a known substance abuser or be considered to be an alcoholic not in remission
• •Have participated in another clinical study in the past 30 days
• •Use of supplemental ginger, ginseng, or Zanthoxylum fruit for 2 weeks prior to randomization and throughout the course of the study.
• •Have a history of allergic reaction to ginseng, ginger or Zanthoxylum fruit
• •Be clinically lactose-intolerant
• •Have any other condition that, in the opinion of the PI, causes the subject to be unsuitable to participate
• •Have taken antibiotics in the last 3 months
• •Have had gastroenteritis ("stomach flu") in the last 3 months
• •Have taken probiotics in the last 3 months (over-the-counter \[OTC\] products or supplements only; food products such as yogurts are permitted).