NCT04368663

The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis

The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Showa Inan General Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pneumatosis Cystoides Intestinalis

Interventions

Type	Name	Description
DRUG	Japanese traditional medicine group	TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.

Timeline

• Start date: 2020-05-01
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2020-04-30
• Last updated: 2025-05-15

Locations

1 site across 1 country: Japan