Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis

July 29, 2007 updated by: Tianjin Nankai Hospital
With multicenter randomized control clinical evaluation investigations, the scheme of integrated medicine treatment of severe acute pancreatitis (SAP) was further improved, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline for integrated medicine of diagnosis and treatment of SAP would be formed, to be popularized all over China.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

300

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Naiqiang Cui, Dr
  • Phone Number: 3892 +86 22 27022268
  • Email: cuinq@sohu.com

Study Locations

  • China
      • Tianjin, China, 300100
        • Recruiting
        • Tianjin Nankai Hospital
        • Contact:
          • Naiqiang Cui, Dr
          • Phone Number: 3892 +86 22 27022268
          • Email: cuinq@sohu.com
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • Recruiting
        • The 1st Affiliated Hospital, Dalian Medical Unversity
        • Contact:
    • Sichuan
      • Chengdu, Sichuan, China, 610041

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 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients 18yr-70yr, complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria), conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5.

Exclusion Criteria:

  • Pregnancy, nursing mother, critical cases of advanced tumor, on the verge of death (estimated to be moral in 12h), severe visceral function disturbance, patients undergoing other therapeutic research that might interfere with the present study.

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: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
1,Mortality 2,Morbidity 3,Crossing stage cure rates 4,Number of operation procedures 5,Incidences of secondary infections 6,Hospitalization days 7,Total expenses 8,Traditional Chinese medicine diagnostic parameters
Time Frame: To observe the relationship between the parameters of the first and second stages and the endpoints
To observe the relationship between the parameters of the first and second stages and the endpoints

Secondary Outcome Measures

Outcome Measure
Time Frame
1.Routine laboratory tests, blood and urine amylase, blood lipase. 2.Important visceral function criteria 3.microorganism culture, endotoxin determination, CRP 4.B-ultrasound, CT, chest films, plain abdomen film
Time Frame: The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge.
The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tianjin Nankai Hospital

Collaborators

Sichuan University

Investigators

  • Principal Investigator: Naiqiang Cui, Dr, Tianjin Nankai Hospital
  • Principal Investigator: Qing Xia, Dr, West China Hospital
  • Principal Investigator: Qinghui Qi, Dr, The 1st Affiliated Hospital, Dalian Medical Unversity

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

October 1, 2006

Study Completion (Anticipated)

October 1, 2009

Study Registration Dates

First Submitted

July 23, 2007

First Submitted That Met QC Criteria

July 23, 2007

First Posted (Estimate)

July 25, 2007

Study Record Updates

Last Update Posted (Estimate)

July 31, 2007

Last Update Submitted That Met QC Criteria

July 29, 2007

Last Verified

July 1, 2007

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2006BAI04A15

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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