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

Showa Inan General Hospital

Status: Enrolling

Conditions: Pneumatosis Cystoides Intestinalis

Treatments: Drug: Japanese traditional medicine group

Study type: Interventional

Funder types: Other

Identifiers

NCT04368663

TJ-134

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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）

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups, including a placebo group

TJ-134 group

Active Comparator group

Description:

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.

Treatment:

Drug: Japanese traditional medicine group

Lactomin group

Placebo Comparator group

Description:

Lactomin (3g/day) is administered to enrolled patients for 8 weeks.

Treatment:

Drug: Japanese traditional medicine group