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

NCT ID: NCT00506337

Last Updated: 2007-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-10-31

Study Completion Date

2009-10-31

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.

Detailed Description

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Conditions

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Pancreatitis, Acute Necrotizing

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Interventions

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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.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sichuan University

OTHER

Sponsor Role collaborator

Tianjin Nankai Hospital

OTHER

Sponsor Role lead

Principal Investigators

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Naiqiang Cui, Dr

Role: PRINCIPAL_INVESTIGATOR

Tianjin Nankai Hospital

Qing Xia, Dr

Role: PRINCIPAL_INVESTIGATOR

West China Hospital

Qinghui Qi, Dr

Role: PRINCIPAL_INVESTIGATOR

The 1st Affiliated Hospital, Dalian Medical Unversity

Locations

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The 1st Affiliated Hospital, Dalian Medical Unversity

Dalian, Liaoning, China

Site Status RECRUITING

West China Hospital, Sichuan Unversity

Chengdu, Sichuan, China

Site Status RECRUITING

Tianjin Nankai Hospital

Tianjin, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Naiqiang Cui, Dr

Role: CONTACT

Phone: +86 22 27022268

Email: [email protected]

Facility Contacts

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Qinghui Qi, Dr

Role: primary

Qing Xia, Dr

Role: primary

Naiqiang Cui, Dr

Role: primary

Other Identifiers

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2006BAI04A15

Identifier Type: -

Identifier Source: org_study_id