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

Tianjin Nankai Hospital

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Pancreatitis, Acute Necrotizing

Treatments: Drug: Qingyi granules

Study type: Interventional

Funder types: Other

Identifiers

NCT00508729

2006BAI04A15-1

Details and patient eligibility

About

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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind