TJ-14 for acute radiation-induced enteritis: open (masking not used) randamized controlled trial

Efficacy of herbal medicine, TJ-14 for acute radiation-induced enteritis: A multi-institutional prospective phase III trial

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT1041190050

Enrollment

100

Registered

2019-06-27

Start date

2020-03-02

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

acute radiation-induced enteritis

Interventions

TJ-14 (Hangeshashinto in Japanese, Ban Xia Xie Xin Tang in Chinese) or Loperamide. These are assigned randamly.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Stool freaquency per day is the baseline plus 3 or more. (2) The irradiated volume was larger than the area described below. Anterior-posterior borders: upper border of the sacral bone to the obsturator foramen. Lateral borders: the sacroiliac joint. (3) Receiving whole pelvis irradiation (total dose 40 Gy or more, dose per fraction 1.5 Gy or more. (4) Age 20 years or more. (5) Possibility of the oral administration of TJ-14 or loperamide. (6) Under radiotherapy. (7) Loose or watery stool. (8) After explaining the study, patients themselves give the consent to be inclued in this study . (9) Karnofsky performance status index 70 or more. (10) Grade 3 or more diarrhea accoding to patient reported outcom: diarrhea.

Exclusion criteria

Exclusion criteria: (1) aldosteronism. (2) hypokalemia (3.5 mEq/l or less). (3) myopathy. (4) pregnancy. (5) dementia or other serious psychological disease. (6) an allergy to TJ-14 or loperamide. (7) systemic inflammatory condition including infectous cloitis (8) 1 month or more steroid usage (oral or tranvenous adniministration) (9) difficulty to keep the treatment position for more than 30 minutes. (10) colostomy (11) a previous history of pelvic and abdominal radiotherapy. (12) Diagnosed with brain metastases, (13) Hepatic failure (14) the usage of another herbal medicine (15) the usage of another anti-diarrhea agent, enteral nutrition agent or opioid. (16) pseudomembranous colitis, ulcerative colitis or hemorrhagic enteritis (17) other unfit patients evaluated by the principal investigator or working under the instructions of the principal investigator,

Design outcomes

Primary

Measure	Time frame
Patient reported outcome (diarrhea)	—

Secondary

Measure	Time frame
Stool number 1, 2, and 3 weeks after the protocol treatment Patient reported outcome (diarrhea) 2 and 3 weeks after the initiation of the treatment protocol, The FACT-G score 1, 2, and 3 weeks after adverse events	—

Contacts

Public ContactTaro Murai

Nagoya City University Hospital

taro8864@yahoo.co.jp+81-52-853-8274

Outcome results

None listed

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