- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04368663
The Beneficial Effect of TJ-134 for Patients With Symptomatic Pneumatosis Cystoides Intestinalis
February 22, 2024 updated by: Akira Horiuchi, Showa Inan General Hospital
The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to(TJ-134)for Patients With Symptomatic Pneumatosis Cystoides
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
- 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.
Study Type
Interventional
Enrollment (Estimated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nagano
-
Komagane, Nagano, Japan, 399-4117
- Recruiting
- Showa Inan General Hospital
-
Contact:
- Akira Horiuchi, M.D.
- Phone Number: 3012 81265822121
- Email: horiuchi.akira@sihp.jp
-
Principal Investigator:
- Akira Horiuchi, M.D.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / 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.
|
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Other Names:
|
Placebo Comparator: Lactomin group
Lactomin (3g/day) is administered to enrolled patients for 8 weeks.
|
TJ-134 (7.5g/day) or lactomin (3g/day) is administered for 8 weeks.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
at enrollment and 8 weeks after the administration of TJ134
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
at enrollment and 8 weeks after the administration of TJ134
|
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).
|
at enrollment and 8 weeks after the administration of TJ134
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 1, 2020
Primary Completion (Estimated)
December 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
April 16, 2020
First Submitted That Met QC Criteria
April 29, 2020
First Posted (Actual)
April 30, 2020
Study Record Updates
Last Update Posted (Actual)
February 23, 2024
Last Update Submitted That Met QC Criteria
February 22, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- TJ-134
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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