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NCT Number: NCT04368663

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

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.

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Key information

Conditions

Pneumatosis Cystoides Intestinalis Digestive System Diseases Gastrointestinal Diseases Intestinal Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Showa Inan General hospital

Komagane, Nagano, 399-4117, Japan

Location status: Recruiting

Location contact

Akira Horiuchi, M.D.

CONTACT

[email protected]

81265822121 ext. 3012

Akira Horiuchi, M.D.

PRINCIPAL_INVESTIGATOR

About this study

  • Based on endoscopic finding, patients with symptomatic PCI are recruited.
  • After enrollment, abdominal symptoms are evaluated and abdominal CT is performed.
  • 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.
  • 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.
  • After the administration of each drug for 8 weeks, abdominal symptoms are evaluated and abdominal CT is performed again.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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）

Treatment and study plan

Japanese traditional medicine group

Drug

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

Other names: Lactomin group

Primary outcomes

  1. Change of computed tomography (CT) findings

    Time frame: 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 outcomes

  1. Bloating and abdominal pain

    Time frame: 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).

  2. Abdominal symptoms

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Showa Inan General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2026
First posted
Apr 30, 2020
Registry last updated
May 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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