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

Primary Purpose

Pancreatitis, Acute Necrotizing

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Qingyi granules
Sponsored by
Tianjin Nankai Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatitis, Acute Necrotizing

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All Sexes

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.

Sites / Locations

  • The 1st Affiliated Hospital, Dalian Medical UnversityRecruiting
  • West China Hospital, Sichuan UnversityRecruiting
  • Tianjin Nankai HospitalRecruiting

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
July 23, 2007
Last Updated
July 29, 2007
Sponsor
Tianjin Nankai Hospital
Collaborators
Sichuan University
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1. Study Identification

Unique Protocol Identification Number
NCT00506337
Brief Title
Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Official Title
Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2009 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tianjin Nankai Hospital
Collaborators
Sichuan University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatitis, Acute Necrotizing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Qingyi granules
Intervention Description
Control group: The therapeutic methods accord to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis" introduced by the Pancreatic Surgery Group of Surgical Chapter of Chinese Medical Association. Treatment group: In addition to the concert schemes cited in the "Guides to diagnosis and treatment of severe acute pancreatitis", during the first stage of the disease herbal Qingyi granules 1-B 4 bags dissolved in water 200ml were administered through the gastric tube q6h. Then the gastric tube was closed for 1h, and Qingyi granules 1-B another 4 bags dissolved in water 400ml were given through enema q6h. During the second stage (from the 2nd week to the 4th week after onset) Qingyi granules 2-B 2bags dissolved in water 200ml were added QD.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Naiqiang Cui, Dr
Phone
+86 22 27022268
Ext
3892
Email
cuinq@sohu.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Naiqiang Cui, Dr
Organizational Affiliation
Tianjin Nankai Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qing Xia, Dr
Organizational Affiliation
West China Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Qinghui Qi, Dr
Organizational Affiliation
The 1st Affiliated Hospital, Dalian Medical Unversity
Official's Role
Principal Investigator
Facility Information:
Facility Name
The 1st Affiliated Hospital, Dalian Medical Unversity
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qinghui Qi, Dr
Email
qiqh@medmail.com.cn
Facility Name
West China Hospital, Sichuan Unversity
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qing Xia, Dr
Email
xiaqing@medmail.com.cn
Facility Name
Tianjin Nankai Hospital
City
Tianjin
ZIP/Postal Code
300100
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiqiang Cui, Dr
Phone
+86 22 27022268
Ext
3892
Email
cuinq@sohu.com

12. IPD Sharing Statement

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

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