UMIN-CTR Clinical Trial

Basic information
Public title	A retrospective study after the completion of 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	A retrospective study after the completion of exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome
Scientific Title	A retrospective study after the completion of 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	A retrospective study after the completion of 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 TJ-137 for the treatment of neuropsychiatric symptoms such as anxiety as well as abdominal symptoms in patients with chronic constipation syndrome using the information obtained from the exploratory study to assess the efficacy and safety of TJ-137 for the treatment of anxiety in patients with chronic constipation syndrome (UMIN000026244). Secondary objective is to clarify the patient's characteristics by metabolome and microbiome analyses.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	1) Tension-Anxiety subscale and anxiety-related items on Profile of Mood States (POMS2, Japanese version) 2) State-Trait Anxiety Inventory (Japanese version) Changes in the above items before and after the treatment of TJ-137
Key secondary outcomes	1) Other subscales on 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 ver.1.2 (Japanese version) 3)Plasma levels of oxytocin, vasopressin, orexin 4) Oxidative stress markers including d-ROMs (Reactive Oxygen Metabolites), BAP (Biological Antioxidant potential) 5) Salivary levels of oxytocin, cortisol, IL-6 6) Plasma levels of metabolites 7) Gut microbiome Changes in the above items before and after the treatment of TJ-137

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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) otherwise deemed ineligible by the study investigator.
Target sample size	24

Research contact person
Name of lead principal investigator	1st name Hiroyuki Middle name Last name Kobayashi
Organization	Kobayashi Medical Clinic Tokyo
Division name	Kobayashi Medical Clinic Tokyo
Zip code	107-0052
Address	2-3-5 Akasaka, Minato-ku, Akasaka Star Gate Plaza 2F, Tokyo
TEL	03-3589-3717
Email	koba@juntendo.ac.jp

Public contact
Name of contact person	1st name Hiroyuki Middle name Last name Kobayashi
Organization	Kobayashi Medical Clinic Tokyo
Division name	Kobayashi Medical Clinic Tokyo
Zip code	107-0052
Address	2-3-5 Akasaka, Minato-ku, Akasaka Star Gate Plaza 2F, Tokyo
TEL	03-3589-3717
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	SOUKEN CO.
Address	1-9-10 Hamamatsucho, Minato-ku, DaiwaA hamamatsucho building 3F, Tokyo
Tel	03-5408-1555
Email	y_huzita@mail.souken-r.com

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

Other administrative information
Date of disclosure of the study information	2020 Year 03 Month 09 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	doi: 10.1016/j.ctcp.2021.101526. Epub ahead of print. PMID: 34974326.
Number of participants that the trial has enrolled	24
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	Main results already published
Date of protocol fixation	2019 Year 11 Month 20 Day
Date of IRB	2019 Year 12 Month 05 Day
Anticipated trial start date	2019 Year 12 Month 19 Day
Last follow-up date	2021 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	1) Effectiveness analysis; Relevance of secondary outcomes to primary outcomes 2) Safety analysis; Adverse events, Side effects

Management information
Registered date	2020 Year 03 Month 09 Day
Last modified on	2022 Year 02 Month 05 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045320