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

Pneumatosis Cystoides Intestinalis Clinical Trial

Official title:

The Beneficial Effect of the Traditional Japanese Medicine, Keishi-ka-shakuyaku-daio-to（TJ-134）for Patients With Symptomatic Pneumatosis Cystoides

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04368663
• Other study ID #: TJ-134
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Showa Inan General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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)

Related Conditions & MeSH terms

• Pneumatosis Cystoides Intestinalis

Intervention

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

Locations

Country	Name	City	State
Japan	Showa Inan General hospital	Komagane	Nagano

Sponsors (1)

Lead Sponsor	Collaborator
Showa Inan General Hospital

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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