Evaluating the effects of a traditional Japanese medicine for patients with intestinal cysts
The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides
This study is testing a traditional Japanese medicine called TJ-134 to see if it can help people with intestinal cysts feel better over 8 weeks.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | Showa Inan General Hospital Academic / other |
| Locations | 1 site (Komagane, Nagano) |
| Trial ID | NCT04368663 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of the traditional Japanese medicine Keishi-ka-shakuyaku-daio-to (TJ-134) in treating patients with symptomatic pneumatosis cystoides intestinalis (PCI). Patients are randomly assigned to receive either TJ-134 or a control treatment, lactomin, for a duration of 8 weeks. The study involves initial evaluations of abdominal symptoms and CT scans, followed by reassessment after the treatment period to determine any changes in symptoms and condition. The trial aims to provide insights into the potential benefits of TJ-134 for managing this rare intestinal condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with symptomatic pneumatosis cystoides intestinalis who exhibit typical findings on colonoscopy.
Not a fit: Patients who are unable to take Keishi-ka-shakuyaku-daio-to (TJ-134) will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could offer a new therapeutic option for patients suffering from symptomatic pneumatosis cystoides intestinalis.
How similar studies have performed: While this approach using traditional Japanese medicine is relatively novel, there may be limited existing studies on similar treatments for pneumatosis cystoides intestinalis.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa Exclusion Criteria: * patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）
Where this trial is running
Komagane, Nagano
- Showa Inan General hospital — Komagane, Nagano, Japan (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.