Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP

NCT ID: NCT00508729

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

2007-10-31

Study Completion Date

2010-10-31

Brief Summary

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With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline 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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Adult patients 18 yr-70 yr
* 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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Peking Union Medical College

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

Zhuming Jiang, Dr

Role: PRINCIPAL_INVESTIGATOR

Peking Union Medical College Hospital

Locations

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Affiliated Hospital of Guangdong Medical College

Zhanjiang, Guangdong, China

Site Status

Guizhou Province People's Hospital

Guiyang, Guizhou, China

Site Status

The 1st Affiliated Hospital, Dalian Medical Unversity

Dalian, Liaoning, China

Site Status

West China Hospital, Sichuan Unversity

Chengdu, Sichuan, China

Site Status

Zhejiang Province People's Hospital

Hangzhou, Zhejiang, China

Site Status

Zhejiang Province Traditional Chinese Medicine Hospital

Hangzhou, Zhejiang, China

Site Status

Dongzhimen Hospital of Beijing Traditional Chinese Medicine University

Beijing, , China

Site Status

Peking Union Medical College Hospital

Beijing, , China

Site Status

Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity

Shanghai, , China

Site Status

Tianjin Nankai Hospital

Tianjin, , China

Site Status

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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Huilai Miao, Dr

Role: primary

Chengxian Shi, Dr

Role: primary

Zaiyuang Ye, Dr

Role: primary

Qin Zhang, Dr

Role: primary

Naiqing Li, Dr

Role: primary

JIngzhe Zhang, Dr

Role: primary

Other Identifiers

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2006BAI04A15-1

Identifier Type: -

Identifier Source: org_study_id