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
Not Applicable
- Conditions
- Chronic constipation syndrome
- Registration Number
- JPRN-UMIN000026244
- Lead Sponsor
- Kobayashi Medical Clinic Tokyo
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- Female
- Target Recruitment
- 25
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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