Unique ID issued by UMIN | UMIN000031559 |
---|---|
Receipt number | R000036034 |
Scientific Title | Exploratory Clinical Study of TJ-83 on Anxiety in Patients with Irritable Bowel Syndrome |
Date of disclosure of the study information | 2018/04/01 |
Last modified on | 2018/03/03 03:19:41 |
Exploratory Clinical Study of TJ-83 on Anxiety in Patients with Irritable Bowel Syndrome
(Brief Title: SWORD-C)
Exploratory Clinical Study of TJ-83 on Anxiety in Patients with Irritable Bowel Syndrome
(Brief Title: SWORD-C)
Japan |
irritable bowel syndrome (IBS)
Psychosomatic Internal Medicine |
Others
NO
To verify the hypothesis that TJ-83 is effective on anxiety in IBS patients.
Safety
Exploratory
Others
Phase IV
State-Trait Anxiety Inventory (STAI)
12 weeks later after the baseline
IBS-QOL
quantitative GI symptoms
Insomnia Severity Index (ISI)
Interventional
Parallel
Randomized
Individual
Open -but assessor(s) are blinded
Placebo
NO
NO
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
standard treatment
standard treatment + TJ-83
20 | years-old | <= |
75 | years-old | >= |
Male and Female
Rome IV
cancer
IBD
state after big surgery
psychiatric disorders
50
1st name | |
Middle name | |
Last name | Shin Fukudo, MD, PhD |
Tohoku University Hospital
Department of Psychosomatic Medicine
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
022-717-8214
sfukudo@med.tohoku.ac.jp
1st name | |
Middle name | |
Last name | Tomotaka Shoji, MD |
Tohoku University Hospital
Department of Psychosomatic Medicine
1-1 Seiryo, Aoba, Sendai 980-8574, Japan
022-717-7327
tshoji@hosp.tohoku.ac.jp
Tohoku University Hospital
Tsumura
Profit organization
NO
2018 | Year | 04 | Month | 01 | Day |
Unpublished
Preinitiation
2018 | Year | 03 | Month | 03 | Day |
2018 | Year | 05 | Month | 01 | Day |
2018 | Year | 03 | Month | 03 | Day |
2018 | Year | 03 | Month | 03 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036034
Research Plan | |
---|---|
Registered date | File name |
Research case data specifications | |
---|---|
Registered date | File name |
Research case data | |
---|---|
Registered date | File name |