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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04368663
Recruitment Status : Recruiting
First Posted : April 30, 2020
Last Update Posted : September 1, 2020
Sponsor:
Information provided by (Responsible Party):
Akira Horiuchi, Showa Inan General Hospital

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
Pneumatosis Cystoides Intestinalis Drug: Japanese traditional medicine group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

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 Name: 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 Name: Lactomin group




Primary Outcome Measures :
  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 Outcome Measures :
  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).



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04368663


Locations
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Japan
Showa Inan General hospital Recruiting
Komagane, Nagano, Japan, 399-4117
Contact: Akira Horiuchi, M.D.    81265822121 ext 3012    horiuchi.akira@sihp.jp   
Principal Investigator: Akira Horiuchi, M.D.         
Sponsors and Collaborators
Showa Inan General Hospital
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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: April 30, 2020    Key Record Dates
Last Update Posted: September 1, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Akira Horiuchi, Showa Inan General Hospital:
Pneumatosis Cystoides Intestinalis
Additional relevant MeSH terms:
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Pneumatosis Cystoides Intestinalis
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases