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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2007 by Tianjin Nankai Hospital.
Recruitment status was  Not yet recruiting
Peking Union Medical College
Information provided by:
Tianjin Nankai Hospital
ClinicalTrials.gov Identifier:
First received: July 26, 2007
Last updated: July 29, 2007
Last verified: July 2007
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 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

Resource links provided by NLM:

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

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Contact: Naiqiang Cui, Dr +86 22 27022268 ext 3892 cuinq@sohu.com

China, Guangdong
Affiliated Hospital of Guangdong Medical College Not yet recruiting
Zhanjiang, Guangdong, China, 524001
Contact: Huilai Miao, Dr       miaohuilai@tom.com   
China, Guizhou
Guizhou Province People's Hospital Not yet recruiting
Guiyang, Guizhou, China, 550002
Contact: Chengxian Shi, Dr       chengxia1@yahoo.com.cn   
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 Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Qin Zhang, Dr       hz166cn@163.com   
Zhejiang Province People's Hospital Not yet recruiting
Hangzhou, Zhejiang, China
Contact: Zaiyuang Ye, Dr       zaiyuanye@163.com   
Dongzhimen Hospital of Beijing Traditional Chinese Medicine University Not yet recruiting
Beijing, China, 100700
Contact: Naiqing Li, Dr       13301119560@m165.com   
Peking Union Medical College Hospital
Beijing, China, 100730
Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity Not yet recruiting
Shanghai, China, 200032
Contact: JIngzhe Zhang, Dr       zjzzzq@sina.com   
Tianjin Nankai Hospital
Tianjin, China, 300100
Sponsors and Collaborators
Tianjin Nankai Hospital
Peking Union Medical College
Principal Investigator: Naiqiang Cui, Dr Tianjin Nankai Hospital
Principal Investigator: Zhuming Jiang, Dr Peking Union Medical College Hospital
  More Information

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

Additional relevant MeSH terms:
Pancreatitis, Acute Necrotizing
Digestive System Diseases
Pancreatic Diseases

ClinicalTrials.gov processed this record on May 26, 2016