Efficacy and Safety of Da-Cheng-Qi Decoction in Severe Acute Pancreatitis

NCT07816900 | Completed DMC

• 3 other identifiers: MR-31-26-0735822026-1782026150
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Intra-abdominal Hypertension; Severe Acute Pancreatitis

Keywords

Da-Cheng-Qi Decoction; traditional Chinese medicine; intra-abdominal pressure; paralytic ileus

Outcome Measures

Primary Outcomes (1)

• Change in Intra-abdominal Pressure

  Intra-abdominal pressure measured by standardized bladder manometry at baseline and every 12 h for 7 days

  From baseline before the first dose through Day 7, assessed every 12 hours after randomization

Secondary Outcomes (5)

• Stool Output

  Day 1 through Day 7

• Length of Hospital Stay

  From randomization to hospital discharge or through study completion, an average of 33 days

• Length of ICU Stay

  From randomization to intensive care unit discharge, up to 28 days

• 28-Day Mortality

  28 days

• Adverse Events

  From randomization to day 28

Study Arms (2)

DCQD Plus Standard Western Treatment

EXPERIMENTAL

The acute-stage component of the integrated Chinese-Western whole-stage protocol. Standard Western treatment for severe acute pancreatitis (acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, organ support) PLUS DCQD granules dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days.

Drug: Da-Cheng-Qi Decoction Plus Standard Western Treatment

Standard Western Treatment

ACTIVE COMPARATOR

Standard Western treatment for severe acute pancreatitis, including acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support (circulatory, respiratory, nutritional), PLUS control granules containing one-tenth of the DCQD dose, dissolved in 100 mL warm water via nasogastric tube twice daily for 7 days, in identical opaque packaging (participant-blinded).

Other: Standard Western Treatment

Interventions

Da-Cheng-Qi Decoction Plus Standard Western Treatment DRUG

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 granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days during the acute stage.

DCQD Plus Standard Western Treatment

Standard Western Treatment OTHER

Standard management of severe acute pancreatitis: acid suppression, fasting, somatostatin analogues, antibiotics when indicated, analgesia, and organ support including circulatory, respiratory, and nutritional support, plus control granules containing one-tenth of the DCQD dose, matching the aroma, appearance, and taste of the full-dose formulation. The control granules are dissolved in 100 mL warm water and administered via nasogastric tube twice daily for 7 days, in identical opaque packaging, so that participants remain blinded to group assignment.

Standard Western Treatment

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Severe acute pancreatitis diagnosed according to the revised Atlanta classification
• Age 18-80 years
• Disease onset within 72 h
• Intra-abdominal hypertension (IAP \>= 12 mmHg) within 24 h of admission
• Written informed consent obtained

You may not qualify if:

• Age \<18 or \>80 years
• Pregnancy or lactation
• Advanced malignancy (pancreatic, hepatobiliary, or gastrointestinal)
• Severe chronic organ failure
• Autoimmune disease or immunosuppression
• Intra-abdominal hemorrhage
• Urinary tract infection or prior bladder surgery (precluding bladder manometry)
• Allergic constitution or known allergy to study medication
• Psychiatric illness

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

MeSH Terms

Conditions

Pancreatitis; Intra-Abdominal Hypertension; Intestinal Pseudo-Obstruction

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Compartment Syndromes; Muscular Diseases; Musculoskeletal Diseases; Vascular Diseases; Cardiovascular Diseases; Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases

Study Officials

• Enqiang Mao, MD, PhD

  Emergency Department, Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants were masked to group assignment; the control preparation was presented in identical packaging to mimic the appearance of the study decoction. A dedicated staff member not involved in outcome assessment prepared and coded the study drugs.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: April 1, 2026
• Primary Completion: July 5, 2026
• Study Completion: July 25, 2026
• Last Updated: September 24, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)