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

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatitis, Acute Necrotizing

Intervention / Treatment
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* Drug: Qingyi granules


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. |