Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP

July 29, 2007 updated by: Tianjin Nankai Hospital

Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline 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 Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital
      • Beijing, China, 100700
        • Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
      • Shanghai, China, 200032
        • Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
      • Tianjin, China, 300100
        • Tianjin Nankai Hospital
    • Guangdong
      • Zhanjiang, Guangdong, China, 524001
        • Affiliated Hospital of Guangdong Medical College
    • Guizhou
      • Guiyang, Guizhou, China, 550002
        • Guizhou Province People's Hospital
    • Liaoning
      • Dalian, Liaoning, China, 116011
        • The 1st Affiliated Hospital, Dalian Medical Unversity
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan Unversity
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Zhejiang Province People's Hospital
      • Hangzhou, Zhejiang, China
        • Zhejiang Province Traditional Chinese Medicine Hospital

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

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients 18 yr-70 yr
  • 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
Mortality
Time Frame: endpoint of the trial
endpoint of the trial
Morbidity
Time Frame: endpoint of the trial
endpoint of the trial
Hospitalization days
Time Frame: endpoint of the trial
endpoint of the trial
Total expenses
Time Frame: endpoint of the trial
endpoint of the trial

Secondary Outcome Measures

Outcome Measure
Time Frame
G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements
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
Parameters of nutrition
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

Peking Union Medical College

Investigators

  • Principal Investigator: Naiqiang Cui, Dr, Tianjin Nankai Hospital
  • Principal Investigator: Zhuming Jiang, Dr, Peking Union Medical College Hospital

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, 2007

Study Completion (Anticipated)

October 1, 2010

Study Registration Dates

First Submitted

July 26, 2007

First Submitted That Met QC Criteria

July 27, 2007

First Posted (Estimate)

July 30, 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

  • 2006BAI04A15-1

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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