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

Sponsor
Showa Inan General Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04368663
Collaborator
(none)
100
Enrollment
1
Location
2
Arms
32
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Japanese traditional medicine group
 N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides
Actual Study Start Date :
May 1, 2020
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

Arm Intervention/Treatment
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
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Other Names:
  • Lactomin group

    		•
    Placebo Comparator: Lactomin group

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

    Drug: Japanese traditional medicine group
    TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
    Other Names:
  • Lactomin group

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change of computed tomography (CT) findings [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 Outcome Measures

    1. Bloating and abdominal pain [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 [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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 100 Years
    Sexes Eligible for Study:
    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:
    • patients can not take Keishi-ka-shakuyaku-daio-to（TJ-134）

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Showa Inan General hospital Komagane Nagano Japan 399-4117

    Sponsors and Collaborators

    • Showa Inan General Hospital

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
    ClinicalTrials.gov Identifier:
    NCT04368663
    Other Study ID Numbers:
    • TJ-134
    First Posted:
    Apr 30, 2020
    Last Update Posted:
    Sep 24, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Akira Horiuchi, Chief of Digestive Disease Center, Showa Inan General Hospital
    Pneumatosis Cystoides Intestinalis
    Additional relevant MeSH terms:
    Pneumatosis Cystoides Intestinalis

    Study Results

    No Results Posted as of Sep 24, 2021