Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP
- Conditions
- Pancreatitis, Acute Necrotizing
- Registration Number
- NCT00508729
- Lead Sponsor
- Tianjin Nankai Hospital
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 300
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Mortality endpoint of the trial Morbidity endpoint of the trial Hospitalization days endpoint of the trial Total expenses endpoint of the trial
- Secondary Outcome Measures
Name Time Method G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements 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 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
Trial Locations
- Locations (10)
Guizhou Province People's Hospital
🇨🇳Guiyang, Guizhou, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
Affiliated Hospital of Guangdong Medical College
🇨🇳Zhanjiang, Guangdong, China
The 1st Affiliated Hospital, Dalian Medical Unversity
🇨🇳Dalian, Liaoning, China
Zhejiang Province People's Hospital
🇨🇳Hangzhou, Zhejiang, China
West China Hospital, Sichuan Unversity
🇨🇳Chengdu, Sichuan, China
Tianjin Nankai Hospital
🇨🇳Tianjin, China
Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
🇨🇳Shanghai, China
Zhejiang Province Traditional Chinese Medicine Hospital
🇨🇳Hangzhou, Zhejiang, China
Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
🇨🇳Beijing, China