Effect of TU-100 on Gastrointestinal and Colonic Transit in Humans

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 60

Inclusion Criteria

Subject is willing and able to provide written informed consent
Males and non-pregnant, non-breastfeeding females;
Subject is willing to undergo multiple radionuclide scans
Subject BMI is between 18 and 35 kg/m2
Subject has a negative urine drug screen
Subject has screening laboratory values that are within normal range for the analyzing laboratory

Exclusion Criteria

Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders.
Unable to withdraw medications 48 hours prior to the study:
Alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
Analgesic drugs including opiates, NSAID, COX 2 inhibitors
GABAergic agents
Benzodiazepines

NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection and birth control pills or depot injections are permissible.

Female subjects who are pregnant or breast feeding.
Clinical evidence (including physical exam, hemoglobin level and review of the medical history) of significant cardiovascular, respiratory, renal, hepatic, pulmonary, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study.
History of allergic reactions to ginseng, ginger, and Sichuan pepper.
History of lactose intolerance.
Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.
Subjects who have participated in another clinical study within the past 30 days.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Daikenchuto (TU-100) 7.5g/day	Daikenchuto (TU-100)	Daikenchuto (TU-100) 2.5g TID (7.5g/day)
Daikenchuto (TU-100) 15g/day	Daikenchuto (TU-100)	Daikenchuto (TU-100) 5g TID (15g/day)
Placebo	Placebo	Placebo TID

Primary Outcome Measures

Name	Time	Method
Ascending colon emptying	1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs
Colonic geometric center at 24 hours	4 hrs, 8 hrs, and 24 hrs
Gastric emptying of solid	1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs

Secondary Outcome Measures

Name	Time	Method
Stool frequency	Day 1, Day 2, Day 3, Day 4, Day 5
Stool consistency	Day 1, Day 2, Day 3, Day 4, Day 5
Colonic geometric center at 4 hours and 48 hours	1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs, 8 hrs, 24 hrs, 48 hrs
Colonic filling at 6 hours	1 hr, 2 hrs, 3 hrs, 4 hrs, 5 hrs, 6 hrs