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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TJ-134 group | Active Comparator | 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. |
|
| Lactomin group | Placebo Comparator | Lactomin (3g/day) is administered to enrolled patients for 8 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Japanese traditional medicine group | Drug | TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks. |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Showa Inan General hospital | Recruiting | Komagane | Nagano | 399-4117 | Japan |
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| ID | Term |
|---|---|
| D011006 | Pneumatosis Cystoides Intestinalis |
| ID | Term |
|---|---|
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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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 |