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Clinical Study on the Therapeutic Effect of Modified Da Chaihu Decoction on Intestinal Function Recovery in Patients with Acute Pancreatitis of Fu Shi Re Jie Syndrome: A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial

Clinical Study on the Therapeutic Effect of Modified Da Chaihu Decoction on Intestinal Function Recovery in Patients with Acute Pancreatitis of Fu Shi Re Jie Syndrome: A Prospective, Multi-center, Randomized, Parallel-controlled Clinical Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001218
Enrollment
Unknown
Registered
2026-05-14
Start date
2024-11-01
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute pancreatitis

Interventions

Control group:Standard treatment
Experimental group:Standard treatment combined with modified Dachaihu Decoction for enema therapy.

Sponsors

Run Run Shaw Hospital, Zhejiang University School of Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: 1: Any 2 of the following 3 criteria: persistent pain in the upper abdomen (acute, severe onset, radiating back); 2) Serum amylase and (or) lipase were 3 times higher than the upper limit of normal; 3) Imaging examination (CT, MRI, or B-ultrasound) showed pancreatic enlargement, exudation, or necrosis. 2: Patients diagnosed as fu-organ heat junction syndrome, at least meet the following 2 main disease +1 tongue and pulse or 1 main disease +2 secondary disease +1 tongue and pulse. The main symptoms include: 1) full abdominal hard pain and refusal to press; 2) Dry stool. Secondary symptoms include: 1) diurnal hot flushes; 2) Vomiting; 3) Bad breath; 4) Short red urine. Tongue pulse: 1) the tongue is red, the fur is yellow, thick and greasy or dry; 2) Large or slippery pulse. 3: 18 -75 years old (including boundary values). 4: Admission within 72 hours of onset. 5: Volunteer to participate in the study and sign the informed consent. If the subject is unable to read and sign the informed consent due to incapacity or other reasons, its guardian is required to represent the informed process and sign the informed consent. If the subject does not have the ability to read the informed consent form (e.g., illiterate subjects), a witness is required to witness the informed process and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1: Acute pancreatitis in pregnancy. 2: Chronic pancreatitis or pancreatitis associated with pancreatic tumors. 3: Patients who have undergone surgical drainage and debridement and need emergency ERCP treatment. 4: A history of severe cardiovascular, respiratory, kidney, liver, hematological, malignant, or immune diseases. 5: Some vulnerable groups, such as mental disorders, cognitive dysfunction. 6: The investigator considered it inappropriate to participate in this clinical study.

Design outcomes

Primary

MeasureTime frame
Intestinal function;

Secondary

MeasureTime frame
Inflammatory indicators and related scores;Total score of TCM syndromes;Intestinal flora;Complications: occurrence of duodenal fistula, organ dysfunction, etc;Length of stay (treatment cycle);Total cost of treatment;The conversion rate of moderate and severe pancreatic inflammation;

Countries

China

Contacts

Public ContactHong Yu

Run Run Shaw Hospital, Zhejiang University School of Medicine

blueyu000@zju.edu.cn13605705907

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 11, 2026