UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026244 |
|---|---|
| Receipt number | 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 12:22:18 |
* 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
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
koba@juntendo.ac.jp
Sponsor or person
Institute
Kobayashi Medical Clinic Tokyo
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030141
