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

Pancreatitis, Acute Necrotizing Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00506337
• Other study ID #: 2006BAI04A15
• Status: Recruiting
• Phase: Phase 2/Phase 3
• First received: July 23, 2007
• Last updated: July 29, 2007
• Start date: October 2006
• Est. completion date: October 2009

Study information

• Verified date: July 2007
• Source: Tianjin Nankai Hospital
• Contact: Naiqiang Cui, Dr
• Phone: +86 22 27022268
• Email: cuinq[@]sohu.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: October 2009
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Acute Necrotizing

Intervention

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.

Locations

Country	Name	City	State
China	West China Hospital, Sichuan Unversity	Chengdu	Sichuan
China	The 1st Affiliated Hospital, Dalian Medical Unversity	Dalian	Liaoning
China	Tianjin Nankai Hospital	Tianjin

Sponsors (2)

Lead Sponsor	Collaborator
Tianjin Nankai Hospital	Sichuan University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.