An interventional study of Da-Cheng-Qi Decoction Plus Standard Western Treatment and Standard Western Treatment in Severe Acute Pancreatitis and Intra-abdominal Hypertension, sponsored by Shanghai Jiao Tong University School of Medicine. Completed at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-09-24.
Sponsored by Shanghai Jiao Tong University School of Medicine · Not applicable, Interventional, and Treatment
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.
Rationale: DCQD, recorded in the Shang Han Lun, is a classical purgative formula. This trial is the acute-stage component of the "Integrated Traditional Chinese and Western Medicine Whole-Stage Treatment Protocol for SAP" (parent study, 200 participants; Medical Research Filing No. MR-31-26-073582; ethics approval 2026-178; funding: Bureau-level project 2026150).
Why only the acute stage was randomized: DCQD is administered during the acute stage (within 72 h of onset), the stage at which prospective randomization is both feasible and scientifically meaningful. Once patients enter the infection stage (Huang-Qin Decoction combined with Du-Shen Decoction) and recovery stage (Si-Jun-Zi Decoction combined with Ban-Xia-Xie-Xin Decoction), allocation has been determined by the acute-stage randomization and the acute-stage intervention has already been administered; separate prospective trials for these stages would be neither feasible nor scientifically meaningful. No independent protocols exist for the later stages; their data are collected within the parent protocol.
Final attribution: Follow-up data from these 60 participants will be fully incorporated into the parent cohort (n = 200) for final analysis. This registration covers the acute-stage randomized comparison of DCQD versus standard Western treatment alone.
DCQD composition: 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.
557 studies on the registry are indexed under Pancreatitis; 164 are open to participants now.
This study's enrollment of 60 is below the median of 100 across 349 interventional studies indexed under Pancreatitis.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
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Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
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.
Change in Intra-abdominal Pressure
Intra-abdominal pressure measured by standardized bladder manometry at baseline and every 12 h for 7 days
Time frame: From baseline before the first dose through Day 7, assessed every 12 hours after randomization
Stool Output
Cumulative stool volume per 24-hour interval.
Time frame: Day 1 through Day 7
Length of Hospital Stay
Duration of hospitalization from admission to discharge
Time frame: From randomization to hospital discharge or through study completion, an average of 33 days
Length of ICU Stay
Duration of intensive care unit stay.
Time frame: From randomization to intensive care unit discharge, up to 28 days
28-Day Mortality
All-cause mortality within 28 days of randomization.
Time frame: 28 days
Adverse Events
Incidence and severity of adverse events during treatment and follow-up.
Time frame: From randomization to day 28
Plan to share: No
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