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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Showa Inan General hospital
Komagane, Nagano, Japan
RECRUITINGChange 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
Time frame: at enrollment and 8 weeks after the administration of TJ134
Bloating and abdominal pain
Both bloating and abdominal pain are evaluated using visual analogue scale (VAS) score (0-100; 0, none).
Time frame: 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).
Time frame: at enrollment and 8 weeks after the administration of TJ134
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