Pneumatosis Cystoides Intestinalis
Conditions
Keywords
Pneumatosis Cystoides Intestinalis
Brief summary
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
1. Based on endoscopic finding, patients with symptomatic PCI are recruited. 2. After enrollment, abdominal symptoms are evaluated and abdominal CT is performed. 3. 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. 4. 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. 5. After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.
Interventions
DRUGJapanese traditional medicine group
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Sponsors
Showa Inan General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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）
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of computed tomography (CT) findings | at enrollment and 8 weeks after the administration of TJ134 | Change of the intraluminal gas pockets in the colon on CT images before and after the administration of TJ-134 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bloating and abdominal pain | at enrollment and 8 weeks after the administration of TJ134 | Both bloating and abdominal pain are evaluated using visual analogue scale (VAS) score (0-100; 0, none). |
| Abdominal symptoms | at enrollment and 8 weeks after the administration of TJ134 | Abdominal symptoms were evaluated on the Gastrointestinal Symptoms Rating Scale (GSRS) one a scale of 1 to5 (1 = none). |
Countries
Japan
Outcome results
None listed