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

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: Pneumatosis Cystoides Intestinalis
• Intervention / Treatment: Drug: Japanese traditional medicine group

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • 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

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bloating and abdominal pain	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	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

• Sponsor: Showa Inan General Hospital

Study record dates

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: Pneumatosis Cystoides Intestinalis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Pneumatosis Cystoides Intestinalis
• 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