a safety and efficacy study of daikenchuto (tu-100) to relieve abdominal bloating in female subjects with irritable bowel syndrome

Conditions: Irritable Bowel Syndrome in Females

Summary: the aim of this study is to assess the effect of orally administered tu-100 (5 g three times daily \[tid\]) as compared to placebo on abdominal bloating rating in female ibs patients.


Eligibility criteria:
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).

Keywords: irritable bowel syndrome rome iii criteria abdominal bloating natural herbal kampo adult ages 18 to 65 female subjects