The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis

Study Overview
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Brief Summary
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The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to is administered to patients with symptomatic pneumatosis cystoides intestinalis (PCI) as compared with lactomin for 8 weeks.

Detailed Description
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Based on endoscopic finding, patients with symptomatic PCI are recruited. After enrollment, abdominal symptoms are evaluated and abdominal CT is performed. Patients were randomized in a 1:1 ratio in blocks of 4 to undergo either the traditional Japanese medicine or lactomin (control). Randomization was carried out by computer-generated random sequences. The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) or lactomin (3g/day) is administered to enrolled patients for 8 weeks. After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.

Official Title
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The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides

Conditions
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Pneumatosis Cystoides Intestinalis

Intervention / Treatment
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* Drug: Japanese traditional medicine group


Participation Criteria
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Eligibility Criteria
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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）

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: TJ-134 group<br>The traditional Japanese medicine, Keishi-ka-shakuyaku-daio-to（TJ-134, 7.5g/day), which consists of a mixture of a compound of peony root (6 g), cinnamon bark (4 g), jujube (4 g), glycyrrhiza (2 g), rhubarb (2 g), and ginger (1 g) is administered to enrolled patients for 8 weeks. | Drug: Japanese traditional medicine group<br>* TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.<br>* Other names: Lactomin group;|
| Placebo Comparator: Lactomin group<br>Lactomin (3g/day) is administered to enrolled patients for 8 weeks. | Drug: Japanese traditional medicine group<br>* TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.<br>* Other names: Lactomin group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of computed tomography (CT) findings | Change of the intraluminal gas pockets in the colon on CT images before and after the administration of TJ-134 | at enrollment and 8 weeks after the administration of TJ134 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bloating and abdominal pain | Both bloating and abdominal pain are evaluated using visual analogue scale (VAS) score (0-100; 0, none). | at enrollment and 8 weeks after the administration of TJ134 | 
| Abdominal symptoms | Abdominal symptoms were evaluated on the Gastrointestinal Symptoms Rating Scale (GSRS) one a scale of 1 to5 (1 = none). | at enrollment and 8 weeks after the administration of TJ134 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumatosis Cystoides Intestinalis