The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis
- Conditions
- Pneumatosis Cystoides Intestinalis
- Interventions
- Drug: Japanese traditional medicine group
- Registration Number
- NCT04368663
- Lead Sponsor
- Showa Inan General Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
- typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa
- patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TJ-134 group Japanese traditional medicine group 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 Japanese traditional medicine group Lactomin (3g/day) is administered to enrolled patients for 8 weeks.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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).
Trial Locations
- Locations (1)
Showa Inan General hospital
🇯🇵Komagane, Nagano, Japan