UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026244
Receipt No. R000030141
Scientific Title Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome
Date of disclosure of the study information 2017/02/21
Last modified on 2017/02/21

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome
Acronym Exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome
Scientific Title Single-center, open-label exploratory study to assess the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of anxiety in patients with chronic constipation syndrome
Scientific Title:Acronym Exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome
Region
Japan

Condition
Condition Chronic constipation syndrome
Classification by specialty
Gastroenterology Psychosomatic Internal Medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Primary objective is to investigate the efficacy and safety of TSUMURA Kamikihito Extract Granules for Ethical Use (TJ-137) for the treatment of neuropsychiatric symptoms, in particular, anxiety as well as abdominal symptoms (such as abdominal pain, abdominal distention and discomfort) in patients with chronic constipation syndrome. Secondary objectives include the analysis of plasma and salivary oxytocin levels, and metabolomic and microbiome analysis of stool samples.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of the following results at baseline,
week 4, and week 12 of study drug
administration:
1) Tension-Anxiety subscale and anxiety-related
items on Profile of Mood States (POMS 2, Japanese version)
2) State-Trait Anxiety Inventory (Japanese version)
Key secondary outcomes 1) Other subscales on Profile of Mood States
(POMS2, Japanese version) not related to anxiety,
including Anger-Hostility, Confusion-Bewilderment, Depression-Dejection, Fatigue-Inertia, Vigor-Activity, Friendliness, and overall negative mood state (Total Mood Disturbance)
2) Gastrointestinal Symptom Rating Scale score
(v 1.2, Japanese version)
3) Plasma levels of oxytocin (OXT), serotonin
(5-HT), dopamine (DA), vasopressin (VSP), and
orexin (OR)
4) Oxidative stress markers including reactive oxygen metabolites (d-ROMS) and biological antioxidant potential (BAP)
5) Salivary levels of OXT, cortisol, IL-6, alpha-amylase, and chromogranin A
6) Changes in plasma metabolites
7) Changes in stool metabolites
8) Changes in gut microbiome

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oral administration of TJ-137
(2.5 g t.i.d) before meals for 90 days
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria 1. diagnosed with chronic constipation syndrome;
2. suffers from anxiety (POMS2 item 23 is 1 or
higher);
3. is 20 years old or older
4. is a female
5. can make outpatient visits
6. is able to provide written consent
Key exclusion criteria Patients who meet any of the following criteria will be excluded from the study:
1. has taken prohibited concomitant medication within two weeks before the start of study;
2. has changed the dose and administration of restricted concomitant medication within two weeks before the start of study;
3. requires a new medication during the study other than the study drug;
4. has serious complications (liver, kidney, heart, and blood disorders or metabolic and psychiatric disorders);
5. is pregnant, breast-feeding or possibly pregnant women;
6. is otherwise deemed ineligible by the study investigator.
Target sample size 25

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroyuki Kobayashi, M.D., Ph.D.
Organization Kobayashi Medical Clinic Tokyo
Division name Kobayashi Medical Clinic Tokyo
Zip code
Address 2-3-5 Akasaka, Minato-ku, Akasaka Star Gate Plaza 2F, Tokyo, 107-0052, Japan
TEL 0335893717
Email koba@juntendo.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyuki Kobayashi, M.D., Ph.D.
Organization Juntendo University Graduate School of Medicine
Division name Department of Hospital Administration, Center for Advanced Kampo Medicine and Clinical Research
Zip code
Address 2-1-1 Hongo, Bunkyo-ku, Tokyo, 113-8421, Japan
TEL 03(3813)3111
Homepage URL
Email koba@juntendo.ac.jp

Sponsor
Institute Kobayashi Medical Clinic Tokyo
Institute
Department

Funding Source
Organization TSUMURA & CO.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 小林メディカルクリニック東京 Kobayashi Medical Clinic Tokyo

Other administrative information
Date of disclosure of the study information
2017 Year 02 Month 21 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2016 Year 08 Month 30 Day
Date of IRB
Anticipated trial start date
2016 Year 09 Month 05 Day
Last follow-up date
2017 Year 01 Month 12 Day
Date of closure to data entry
2017 Year 02 Month 22 Day
Date trial data considered complete
2017 Year 02 Month 28 Day
Date analysis concluded
2018 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 21 Day
Last modified on
2017 Year 02 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030141

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.