UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039743 |
|---|---|
| Receipt number | R000045320 |
| 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 |
| Date of disclosure of the study information | 2020/03/09 |
| Last modified on | 2022/02/05 09:15:29 |
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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
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
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
SOUKEN CO.
Address
1-9-10 Hamamatsucho, Minato-ku, DaiwaA hamamatsucho building 3F, Tokyo
Tel
03-5408-1555
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045320
