Clinical trial NCT00508729: Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP
Official title: Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Pancreatitis, Acute Necrotizing
Lead sponsor: Tianjin Nankai Hospital
Sponsor class: OTHER
Collaborators: name: Peking Union Medical College
First posted: 2007-07-30
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Mortality
timeFrame: endpoint of the trial
measure: Morbidity
timeFrame: endpoint of the trial
measure: Hospitalization days
timeFrame: endpoint of the trial
measure: Total expenses
timeFrame: endpoint of the trial
Secondary outcomes:
measure: G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements
timeFrame: 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
measure: Parameters of nutrition
timeFrame: 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
Other outcomes:
Locations:
city: Zhanjiang
country: China
facility: Affiliated Hospital of Guangdong Medical College
state: Guangdong
city: Guiyang
country: China
facility: Guizhou Province People's Hospital
state: Guizhou
city: Dalian
country: China
facility: The 1st Affiliated Hospital, Dalian Medical Unversity
state: Liaoning
city: Chengdu
country: China
facility: West China Hospital, Sichuan Unversity
state: Sichuan
city: Hangzhou
country: China
facility: Zhejiang Province People's Hospital
state: Zhejiang
city: Hangzhou
country: China
facility: Zhejiang Province Traditional Chinese Medicine Hospital
state: Zhejiang
city: Beijing
country: China
facility: Dongzhimen Hospital of Beijing Traditional Chinese Medicine University
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Shanghai
country: China
facility: Longhua Hospital of Shanghai Traditional Chinese Medicine Unversity
city: Tianjin
country: China
facility: Tianjin Nankai Hospital
Study officials:
affiliation: Tianjin Nankai Hospital
name: Naiqiang Cui, Dr
role: PRINCIPAL_INVESTIGATOR
affiliation: Peking Union Medical College Hospital
name: Zhuming Jiang, Dr
role: PRINCIPAL_INVESTIGATOR
References: