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

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 - 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

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000026244

Enrollment

Registered

2017-02-21

Start date

2016-09-05

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

Oral administration of TJ-137 (2.5 g t.i.d) before meals for 90 days

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. is otherwise deemed ineligible by the study investigator.

Design outcomes

Primary

Measure	Time frame
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)	—

Secondary

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

Japan

Contacts

Public ContactHiroyuki Kobayashi, M.D., Ph.D.

Juntendo University Graduate School of Medicine Department of Hospital Administration, Center for Advanced Kampo Medicine and Clinical Research

koba@juntendo.ac.jp03(3813)3111

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026