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

ConditionPneumatosis Cystoides Intestinalis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorShowa Inan General Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Japanese traditional medicine group

    Drug

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

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: TJ-134 groupActive comparator 1 intervention
Group B: Lactomin groupPlacebo comparator 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Showa Inan General Hospital

Lead sponsor

Source ClinicalTrials.gov
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