A Phase 2 interventional study of Oral/enteral TJ-100 solution and Oral/enteral placebo solution in Paralytic Ileus, sponsored by Wakayama Medical University. Status unknown at 5 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2013-12-18.
Sponsored by Wakayama Medical University · Phase 2, Interventional, and Prevention
A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.
Daikenchuto (TJ-100), a traditional Japanese herbal medicine, is used for prevention and treatment of postoperative ileus. TJ-100 extract powder (Tsumura \& Co., Tokyo, Japan) is manufactured as an aqueous extract containing 2.2 % Japanese pepper, 5.6 % processed ginger, 3.3 % ginseng, and 88.9 % maltose syrup powder. A recent randomized, parallel-group, double-blind, placebo-controlled, dose-response trial demonstrated that TJ-100 accelerates colonic transit time, particularly in the ascending colon. Given its potential actions in the intestinal tract, it seems reasonable to postulate that TJ-100 may play a role in improving and preventing bowel dysmotility. This study was designed to investigate the effect of TJ-100 on intestinal dysmotility and for the prevention of postoperative paralytic ileus in patients undergoing pancreaticoduodenectomy.
The primary endpoint is the incidence of postoperative paralytic ileus. Secondary endpoints are QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) and visual analogue scale, the change in ratio of abdominal circumference, the incidence of postoperative complications, the length of hospital day, and the incidence of surgical site infection. Two hundred patients are required for the study (100 patients per group).
124 studies on the registry are indexed under Ileus; 12 are open to participants now.
This study's planned enrollment of 220 is above the median of 97 across 106 interventional studies indexed under Ileus.
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Oral/enteral TJ-100 solution
Drug: Oral/enteral TJ-100 solution
Oral/enteral placebo solution
Drug: Oral/enteral placebo solution
Oral TJ-100 solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent TJ-100 solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.
Also known as: A
Oral placebo solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent placebo solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.
Also known as: B
Incidence of postoperative paralytic ileus (including the duration of paralysis)
Delayed passage of first flatus for 72 hours (3.0 days) after surgery, or a postoperative condition that requires an intervention for the ileus. Every 12 hours is counted as 0.5 postoperative day and every 24 hours as 1.0 postoperative day.
Time frame: 72 hours
The duration until the first flatus after surgery.
The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.
Time frame: 14 days
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)
QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version) on postoperative day 7.
Time frame: 7 days
Abdominal pain and abdominal distention scores on the Visual Analogue Scale.
Abdominal pain and abdominal distention scores on the Visual Analogue Scale on postoperative day 3.
Time frame: 3 days
The change ratio of abdominal circumference.
The change ratio of abdominal circumference on postoperative day 3 and operative day just after surgery
Time frame: 3 days
The incidence of postoperative complication.
The incidence of postoperative complication based on Dindo's classification.
Time frame: 14 days
The length of postoperative hospital day.
Patients were discharged only when they fulfilled the criteria as follows: a return to preoperative activities of daily living, no deep-site infections, normal laboratory data, no drains, and the possibility for oral nutrition above the basal metabolism.
Time frame: 30 days
The incidence of surgical site infection.
Intra-abdominal abscess was defined as intra-abdominal fluid collection with positive cultures identified by ultrasonography or computed tomography associated with persistent fever and elevations of white blood cell counts.
Time frame: 30 days
The long term incidence of postoperative ileus after surgery.
The follow-up investigation of the long term incidence of postoperative ileus is scheduled in two years after surgery.
Time frame: 2 years
This study is status unknown, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Wakayama Medical University