The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Japanese traditional medicine group.
- Who it may be relevant to
- Registry conditions: Pneumatosis Cystoides Intestinalis. Basic parameters: 18 years — 100 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Japan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides
Overview
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
- Drug Japanese traditional medicine group
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Primary outcome measures
- Change of computed tomography (CT) findings [Time frame: at enrollment and 8 weeks after the administration of TJ134]
Secondary outcome measures (2)
- Bloating and abdominal pain [Time frame: at enrollment and 8 weeks after the administration of TJ134]
- Abdominal symptoms [Time frame: at enrollment and 8 weeks after the administration of TJ134]
Eligibility criteria
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）
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Japan · 1 center
- Showa Inan General hospital — Komagane
Identifiers
NCT: NCT04368663 · TJ-134