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Efficacy and Safety of Da-Cheng-Qi Decoction in Severe Acute Pancreatitis
Sponsor: Shanghai Jiao Tong University School of Medicine
Summary
This single-center prospective randomized controlled trial evaluated Da-Cheng-Qi Decoction (DCQD) as the acute-stage intervention of an integrated traditional Chinese and Western medicine whole-stage treatment protocol for severe acute pancreatitis (SAP). Sixty adults with SAP and intra-abdominal hypertension (IAP ≥ 12 mmHg) were randomized within 72 h of onset to receive standard Western treatment plus DCQD (100 mL via nasogastric tube twice daily for 7 days) or standard Western treatment alone. The primary outcome was intra-abdominal pressure measured by standardized bladder manometry every 12 h for 7 days. Secondary outcomes included stool output, length of hospital and ICU stay, and 28-day mortality. The trial was conducted at the Emergency Intensive Care Unit of Ruijin Hospital between April 2026 and July 2026.
Official title: Efficacy and Safety of Da-Cheng-Qi Decoction in the Acute Stage of Severe Acute Pancreatitis: a Single-Center, Prospective, Randomized, Controlled Trial
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-04-01
Completion Date
2026-07-25
Last Updated
2026-09-14
Healthy Volunteers
No
Interventions
Da-Cheng-Qi Decoction Plus Standard Western Treatment
Participants in this arm receive standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and circulatory, respiratory, and nutritional support) PLUS Da-Cheng-Qi Decoction, a classical purgative herbal formula comprising Rheum palmatum L. (15 g, added later), processed Magnolia officinalis (12 g), honey-bran-fried Citrus aurantium L. (15 g), and mirabilite (15 g), prescribed by TCM physicians on the basis of syndrome differentiation and prepared by the Department of Traditional Chinese Medicine. DCQD is administered 100 mL via nasogastric tube twice daily for 7 days during the acute stage.
Standard Western Treatment
Standard management of severe acute pancreatitis: acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support including circulatory, respiratory, and nutritional support.
Locations (1)
Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China