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

Inclusion Criteria:

- Meet Rome III criteria for IBS (any subtype)

- Female aged 18 to 65 years, inclusive

- If of childbearing potential, prepared to use suitable forms of contraception
throughout the study and for 30 days after the last dose i.e., hormonal
contraceptives (such as oral contraceptives, Depo-Provera, NuvaRing, Essure), condoms
used with a spermicide, an intrauterine device, or abstinence. Females are not
considered to be of childbearing potential if they are naturally postmenopausal (no
menses for at least 1 year and, if < 55 years of age, have a documented
follicle-stimulating hormone [FSH] level of ≥ 35 mIU/mL) or have documentation of
surgical sterility

- Have a BMI between 18 and 30 kg/m2, inclusive

- Have a negative pregnancy urine screening at Visit 1, if of childbearing potential

- Able to provide written consent

- Able to take oral administration of the testing medications

- Have a self-reported average abdominal bloating rating (>3 daily ratings over the
preceding 7 days) equal or greater than 4 on a numerical scale of 0 to 20.

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).