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

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 - 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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000039743

Enrollment

Registered

2020-03-09

Start date

2019-12-19

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic constipation syndrome

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

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

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
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	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroyuki Kobayashi

Kobayashi Medical Clinic Tokyo Kobayashi Medical Clinic Tokyo

koba@juntendo.ac.jp03-3589-3717

Outcome results