TJ-14 for acute radiation-induced enteritis: open (masking not used) randamized controlled trial
- Conditions
- acute radiation-induced enteritis
- Registration Number
- JPRN-jRCT1041190050
- Lead Sponsor
- Murai Taro
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 100
(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.
(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,
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method