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

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 SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Affiliated Hospital of Guangdong Medical College
  • Guizhou Province People's Hospital
  • The 1st Affiliated Hospital, Dalian Medical Unversity
  • West China Hospital, Sichuan Unversity
  • Zhejiang Province People's Hospital
  • Zhejiang Province Traditional Chinese Medicine Hospital
  • Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
  • Peking Union Medical College Hospital
  • Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
  • Tianjin Nankai Hospital

Outcomes

Primary Outcome Measures

Mortality
Morbidity
Hospitalization days
Total expenses

Secondary Outcome Measures

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

Full Information

First Posted
July 26, 2007
Last Updated
July 29, 2007
Sponsor
Tianjin Nankai Hospital
Collaborators
Peking Union Medical College
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1. Study Identification

Unique Protocol Identification Number
NCT00508729
Brief Title
Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP
Official Title
Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2007
Overall Recruitment Status
Unknown status
Study Start Date
October 2007 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Tianjin Nankai Hospital
Collaborators
Peking Union Medical College

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

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
Primary Outcome Measure Information:
Title
Mortality
Time Frame
endpoint of the trial
Title
Morbidity
Time Frame
endpoint of the trial
Title
Hospitalization days
Time Frame
endpoint of the trial
Title
Total expenses
Time Frame
endpoint of the trial
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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
Zhuming Jiang, Dr
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Affiliated Hospital of Guangdong Medical College
City
Zhanjiang
State/Province
Guangdong
ZIP/Postal Code
524001
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Huilai Miao, Dr
Email
miaohuilai@tom.com
Facility Name
Guizhou Province People's Hospital
City
Guiyang
State/Province
Guizhou
ZIP/Postal Code
550002
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chengxian Shi, Dr
Email
chengxia1@yahoo.com.cn
Facility Name
The 1st Affiliated Hospital, Dalian Medical Unversity
City
Dalian
State/Province
Liaoning
ZIP/Postal Code
116011
Country
China
Facility Name
West China Hospital, Sichuan Unversity
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
Zhejiang Province People's Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zaiyuang Ye, Dr
Email
zaiyuanye@163.com
Facility Name
Zhejiang Province Traditional Chinese Medicine Hospital
City
Hangzhou
State/Province
Zhejiang
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Qin Zhang, Dr
Email
hz166cn@163.com
Facility Name
Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
City
Beijing
ZIP/Postal Code
100700
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Naiqing Li, Dr
Email
13301119560@m165.com
Facility Name
Peking Union Medical College Hospital
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
City
Shanghai
ZIP/Postal Code
200032
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
JIngzhe Zhang, Dr
Email
zjzzzq@sina.com
Facility Name
Tianjin Nankai Hospital
City
Tianjin
ZIP/Postal Code
300100
Country
China

12. IPD Sharing Statement

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

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