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Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients

Exploratory study of clinical effectiveness and safety of TJ-116 bukuryoingohangekobokuto for anxiety and postoperative water brash in esophageal cancer patients - Investigation of TJ-116 bukuryoingohangekobokuto for postoperative water brash in esophageal cancer.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000031330
Enrollment
24
Registered
2018-02-16
Start date
2018-03-01
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

Esophageal cancer

Interventions

Conventional treatment In addition to conventional treatment, bukuryoingohangekobokuto is divided into 3 times 7.5 g per day (2.5 g (1 package) once a day), from 2 weeks before operation to 6 weeks af

Sponsors

Department of Education and Support for Regional Medicine. Department of Kampo medicine
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Patients waiting for chest upper to lower esophageal cancer radical resection 2. Pre treatment cStage:II, III, IVA (except for T4b, N3) TNM classification:T=1-4a, N=0-2, M=0(TNM-UICC 8 th edition) 3. Performance Status:0-2 4. Hospital Anxiety and Depression Scale (HADS): 8 <= 5. 20 years old and over 6. Medical examination classification:outpatient and inpatient 7. Patients who obtain document consent from the principal

Exclusion criteria

Exclusion criteria: 1. Patients who have past history of abdominal surgery 2 Patients who have past history of ileus 3 Patients with concomitant inflammatory bowel disease such as ulcerative colitis and crohn disease 4. Eemergent surgery 5. Patients who took prohibited concomitant drugs 4 weeks before treatment 6. Patients who have past history of radiotherapy and radiation chemotherapy for esophageal cancer 7. Patients who have past history of allergy for other Kampo formulation(s) 8. Patients who have serious concomitant diseases 9. A woman who is pregnant, has a possibility of pregnancy, is within 28 days after birth, is breastfeeding 10. Dementia patients 11. Others, including patients who are unfit for the study as determined by the attending physician

Design outcomes

Primary

MeasureTime frame
Symptoms of feeling, anxiety, water brash

Secondary

MeasureTime frame
1. Incidence frequency of aspiration pneumonia 2. Postoperative hospital stay 3. Abdominal gas volume 4. Inflammatory marker (IL-6,TNFa,G-CSF,WBC) 5. Chest CT 6. Nutritional status (Body weight, BMI, TSF, AMC, Grip strength,In Body Analysis, CONUT, nutrition-related markers) 7. Clinical examination

Countries

Japan

Contacts

Public ContactShin Takayama

Tohoku University Hospital Department of Education and Support for Regional Medicine. Department of Kampo medicine

takayama@med.tohoku.ac.jp022-717-7507

Outcome results

None listed

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