Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer

Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer - Evaluation of safety and efficacy of perioperative administration of TJ-100 in patients with postoperative functional aberration of the gastrointestinal tract due to surgery for colon cancer

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000032697

Enrollment

200

Registered

2018-05-24

Start date

2018-01-18

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

colon cancer

Interventions

oral administration of TJ-100(15g/day) in perioperative surgery

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.Patients with curative resection for colon cancer including cancer of the rectosigmoid that had been diagnosed pre-operatively 2.Patients with a performance status of 0 or 1 3.Patients able to tolerate oral administration of TJ-100 4.Patients aged 20 years or older 5.Patients able to provide written informed consent

Exclusion criteria

Exclusion criteria: 1.Patients taking other Kampo medicines 2.Patients were pregnant, possibly pregnant or considering pregnancy 3.Patients with serious ischemic heart disease 4.Patients with cirrhosis or active hepatitis 5.Patients with dyspnea requiring oxygen administration 6.Patients under dialysis due to chronic renal failure 7.Patients requiring combined resection of any other organ 8.Patients ineligible for the study for any other reason, as judged by the investigator

Design outcomes

Primary

Measure	Time frame
the time until first flatus following colon surgery	—

Secondary

Measure	Time frame
1.The time until first defecation following colon surgery 2.CRP, WBC, neutrophil of POD 1,3 3.The maximumu of body temperature 4.Hospital stay after colorectal surgery 5.Postoperative complication 6.Adverse events	—

Countries

Japan

Contacts

Public ContactToshihiko Nishidate

Sapporo Medical University Department of Surgery, Surgical Oncology and Science

nisidate@sapmed.ac.jp011-611-2111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026