NCT04368663

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
8mo left

Started May 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress90%
May 2020Dec 2026

First Submitted

Initial submission to the registry

April 16, 2020

Completed
14 days until next milestone

First Posted

Study publicly available on registry

April 30, 2020

Completed
1 day until next milestone

Study Start

First participant enrolled

May 1, 2020

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

6.7 years

First QC Date

April 16, 2020

Last Update Submit

May 14, 2025

Conditions

Pneumatosis Cystoides Intestinalis

Keywords

Pneumatosis Cystoides Intestinalis

Outcome Measures

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

    at enrollment and 8 weeks after the administration of TJ134

Secondary Outcomes (2)

  • Bloating and abdominal pain

    at enrollment and 8 weeks after the administration of TJ134

  • Abdominal symptoms

    at enrollment and 8 weeks after the administration of TJ134

Study Arms (2)

TJ-134 group

ACTIVE COMPARATOR

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

Lactomin group

PLACEBO COMPARATOR

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

Drug: Japanese traditional medicine group

Interventions

Japanese traditional medicine groupDRUG

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

Also known as: Lactomin group
Lactomin groupTJ-134 group

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • typical findings of PCI on colonoscopy; Line or pebble like sessile cysts are distributed around the colon with normal overlying mucosa

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Showa Inan General hospital

Komagane, Nagano, 399-4117, Japan

RECRUITING

MeSH Terms

Conditions

Pneumatosis Cystoides Intestinalis

Condition Hierarchy (Ancestors)

Intestinal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chief of Digestive Disease Center

Study Record Dates

First Submitted

April 16, 2020

First Posted

April 30, 2020

Study Start

May 1, 2020

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

JP(1)