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Clinical Trials/JPRN-jRCTs041180063
JPRN-jRCTs041180063
Active, not recruiting
Phase 3

A randomized, double-blind study on the effect of daiobotanpito as additional option in treating acute diverticulitis - DADIDA trial

Ogawa Keiko0 sites170 target enrollmentMarch 1, 2019
Conditionsdiverticulitis

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
diverticulitis
Sponsor
Ogawa Keiko
Enrollment
170
Status
Active, not recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 1, 2019
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Ogawa Keiko

Eligibility Criteria

Inclusion Criteria

  • Participants who meet the following criteria are eligible
  • (a) Moderate to severe diverticulitis
  • Diagnosis was based on the image of Computed Tomography (CT),
  • diverticulalike structure in accordance with tenderness or abdominal pain, a thickening of colon wall, signs of inflammation of the pericolonic fat, the tissue density, and vascular involvement. Pericolonic abscess, free air or extravasation, and accumulation of fluid were also noticed to predict prognosis.
  • (b)At least 20 years old and under 75 years old
  • (c)Patients who can communicate with each other
  • (d)Patients with abdominal pain and/or fever above 37\.5 degrees
  • (e)After receiving sufficient explanation for the participation of this study, after sufficient understanding, the patient's willingness to freely by written agreement to be obtained.

Exclusion Criteria

  • (a) Patients with severe dysfunction in the following organs.
  • (Blood tests are allowed within 4 weeks before treatment starts)
  • Renal function: serum creatinine value\> 1\.5 times the upper limit of institution standard
  • Liver function: serum AST value or serum ALT value\> 3 times the facility reference upper limit value
  • Central nervous function: encephalopathy or a patient suspected of it
  • Electrolyte: serum Na \<125 mEq / L, serum K \<3\.3 mEq / L
  • (b) Patients considered highly likely to have perforation of abscess due to malnutrition (Alb \<2\.5 g / dL)
  • (c) Patients with obstructive ileus symptoms
  • (d) Patients who have chronic anorexia, abdominal pain, diarrhea symptoms before the onset of coloren diverticulitis
  • (e) Before the onset of colorectal diverticulitis, Performance Status (PS), one of the indicators of the general condition and the degree of restriction of the patient's daily life, is 3 or above

Outcomes

Primary Outcomes

Not specified

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