Pancreatitis, Acute Necrotizing
Conditions
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.
Interventions
DRUGQingyi granules
Sponsors
Peking Union Medical College
Tianjin Nankai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mortality | endpoint of the trial |
| Morbidity | endpoint of the trial |
| Hospitalization days | endpoint of the trial |
| Total expenses | endpoint of the trial |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
China
Contacts
Primary ContactNaiqiang Cui, Dr
Outcome results
None listed