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RecruitingNCT04368663Updated Aug 11, 2026

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

An interventional study of Japanese traditional medicine group in Pneumatosis Cystoides Intestinalis, sponsored by Showa Inan General Hospital. Recruiting at 1 site in Japan. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-11.

Sponsored by Showa Inan General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Started May 2020; still recruiting 6 years 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Ages
18 Years to 100 Years
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Pneumatosis Cystoides Intestinalis

Keywords

  • Pneumatosis Cystoides Intestinalis
03

In context

Lead sponsor

Showa Inan General Hospital is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    TJ-134 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.

    Drug: Japanese traditional medicine group

  • Placebo comparator
    Lactomin group

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

    Drug: Japanese traditional medicine group

Interventions

  • DrugJapanese traditional medicine group

    TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.

    Also known as: Lactomin group

06

What researchers measure

Primary outcomes

  1. Change 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

Secondary outcomes

  1. 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

  2. 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

07

Study locations

1 of 1 sites recruiting
  • Showa Inan General hospital
    Komagane, Nagano 399-4117, Japan
    • Akira Horiuchi, M.D. · Contact · horiuchi.akira@sihp.jp · 81265822121
    • Akira Horiuchi, M.D. · Principal investigator
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 11, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04368663
Lead sponsor
Showa Inan General Hospital
Responsible party
Akira Horiuchi (Chief of Digestive Disease Center, Showa Inan General Hospital) — Principal investigator
First posted
Apr 30, 2020
Start date
May 1, 2020
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Aug 11, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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