UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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
Title of the study (Brief title)	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	Hiroyuki Kobayashi, M.D., Ph.D.
Organization	Kobayashi Medical Clinic Tokyo
Division name	Kobayashi Medical Clinic Tokyo
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	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
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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