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

JRCT ID: jRCT1041190050

Registered date:27/06/2019

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: acute radiation-induced enteritis
• Date of first enrollment: 02/03/2020
• Target sample size: 100
• Study type: Interventional

Intervention(s)

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

Outcome(s)

• Primary Outcome: Patient reported outcome (diarrhea)

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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,

Related Information

• Primary Sponsor: Murai Taro
• Source(s) of Monetary Support: The Research Foundation of Oriental Medicine,Grants-in-Aids for Scientific Research from the Japanese Ministry of Education