Evaluation of Effect of Integrated Treatment by Traditional Chinese and Western Medicine for Severe Acute Pancreatitis
1 other identifier
interventional
300
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2006
Typical duration for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 23, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2009
CompletedJuly 31, 2007
July 1, 2007
July 23, 2007
July 29, 2007
Conditions
Outcome Measures
Primary Outcomes (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
To observe the relationship between the parameters of the first and second stages and the endpoints
Secondary Outcomes (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
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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tianjin Nankai Hospitallead
- Sichuan Universitycollaborator
Study Sites (3)
The 1st Affiliated Hospital, Dalian Medical Unversity
Dalian, Liaoning, 116011, China
West China Hospital, Sichuan Unversity
Chengdu, Sichuan, 610041, China
Tianjin Nankai Hospital
Tianjin, 300100, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 23, 2007
First Posted
July 25, 2007
Study Start
October 1, 2006
Study Completion
October 1, 2009
Last Updated
July 31, 2007
Record last verified: 2007-07