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

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ClinicalTrials.gov Identifier: NCT00506337
Recruitment Status : Unknown
Verified July 2007 by Tianjin Nankai Hospital.
Recruitment status was:  Recruiting
First Posted : July 25, 2007
Last Update Posted : July 31, 2007
Sponsor:
Collaborator:
Sichuan University
Information provided by:
Tianjin Nankai Hospital

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.

Condition or disease Intervention/treatment Phase
Pancreatitis, Acute Necrotizing Drug: Qingyi granules Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
Study Start Date : October 2006
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis
U.S. FDA Resources


Intervention Details:
    Drug: Qingyi granules

    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 Measures :
  1. 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 Measures :
  1. 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. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00506337


Contacts
Contact: Naiqiang Cui, Dr +86 22 27022268 ext 3892 cuinq@sohu.com

Locations
China, Liaoning
The 1st Affiliated Hospital, Dalian Medical Unversity Recruiting
Dalian, Liaoning, China, 116011
Contact: Qinghui Qi, Dr       qiqh@medmail.com.cn   
China, Sichuan
West China Hospital, Sichuan Unversity Recruiting
Chengdu, Sichuan, China, 610041
Contact: Qing Xia, Dr       xiaqing@medmail.com.cn   
China
Tianjin Nankai Hospital Recruiting
Tianjin, China, 300100
Contact: Naiqiang Cui, Dr    +86 22 27022268 ext 3892    cuinq@sohu.com   
Sponsors and Collaborators
Tianjin Nankai Hospital
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

ClinicalTrials.gov Identifier: NCT00506337     History of Changes
Other Study ID Numbers: 2006BAI04A15
First Posted: July 25, 2007    Key Record Dates
Last Update Posted: July 31, 2007
Last Verified: July 2007

Additional relevant MeSH terms:
Pancreatitis
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Digestive System Diseases