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

This study is not yet open for participant recruitment.

Verified by Tianjin Nankai Hospital, July 2007

Sponsors and Collaborators:	Tianjin Nankai Hospital Peking Union Medical College
Information provided by:	Tianjin Nankai Hospital
ClinicalTrials.gov Identifier:	NCT00508729

Purpose

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.

Condition	Intervention	Phase
Pancreatitis, Acute Necrotizing	Drug: Qingyi granules	Phase II Phase III

MedlinePlus related topics: Nutritional Support

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

Further study details as provided by Tianjin Nankai Hospital:

Primary Outcome Measures:

Mortality [ Time Frame: endpoint of the trial ]
Morbidity [ Time Frame: endpoint of the trial ]
Hospitalization days [ Time Frame: endpoint of the trial ]
Total expenses [ Time Frame: endpoint of the trial ]

Secondary Outcome Measures:

G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements [ Time Frame: 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 ]
Parameters of nutrition [ Time Frame: 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 ]

Estimated Enrollment:	300
Study Start Date:	October 2007
Estimated Study Completion Date:	October 2010

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00508729

Contacts

Contact: Naiqiang Cui, Dr

+86 22 27022268 ext 3892

cuinq@sohu.com

Locations

China
Tianjin Nankai Hospital
Tianjin, China, 300100
Peking Union Medical College Hospital
Beijing, China, 100730
Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
Beijing, China, 100700
Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
Shanghai, China, 200032
China, Guangdong
Affiliated Hospital of Guangdong Medical College
Zhanjiang, Guangdong, China, 524001
China, Guizhou
Guizhou Province People's Hospital
Guiyang, Guizhou, China, 550002
China, Liaoning
The 1st Affiliated Hospital, Dalian Medical Unversity
Dalian, Liaoning, China, 116011
China, Sichuan
West China Hospital, Sichuan Unversity
Chengdu, Sichuan, China, 610041
China, Zhejiang
Zhejiang Province Traditional Chinese Medicine Hospital
Hangzhou, Zhejiang, China
Zhejiang Province People's Hospital
Hangzhou, Zhejiang, China

Sponsors and Collaborators

Tianjin Nankai Hospital

Peking Union Medical College

Investigators

Principal Investigator:	Naiqiang Cui, Dr	Tianjin Nankai Hospital
Principal Investigator:	Zhuming Jiang, Dr	Peking Union Medical College Hospital

More Information

Study ID Numbers:	2006BAI04A15-1
Study First Received:	July 26, 2007
Last Updated:	July 29, 2007
ClinicalTrials.gov Identifier:	NCT00508729
Health Authority:	China: Ministry of Health

Study placed in the following topic categories:

Digestive System Diseases
Pancreatitis, Acute Necrotizing
Pancreatic Diseases
Pancreatitis

ClinicalTrials.gov processed this record on January 16, 2009