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"Strengthening Spleen and Purging Fu-organs" Method Intervention for Early Enteral Nutrition in predicted Severe Acute Pancreatitis: A Multiple-Center, Double-Blind, Placebo-Controlled Randomized Trial

Clinical study on the intervention of early enteral nutrition in acute pancreatitis with the method of "strengthening spleen and purging fu-organs"

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400081325
Enrollment
Unknown
Registered
2024-02-28
Start date
2024-03-01
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

acute pancreatitis

Interventions

JPTF treatment group:JPTF granule oral/nasal feed, once every 6 hours
placebo control group:placebo granule oral/nasal feed, once every 6 hours

Sponsors

Jinjiang Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18 to 80 years (2) Meets the diagnostic criteria for "Acute Pancreatitis" (3) Meets the "predicted Severe Acute Pancreatitis" diagnostic criteria (APACHE II score = 8, or Imrie score = 3 , or CRP>150mg/L) (4) Meets the diagnostic criteria for "spleen deficiency and fu-organ excess" in TCM (5) Admission within 72 hours after onset of Acute Pancreatitis (6) Expected hospitalization time exceeds 7 days (7) Informed consent

Exclusion criteria

Exclusion criteria: (1) Pregnant pancreatitis (2) Severe respiratory failure, severe systemic circulatory failure, coma, or other dangerous symptoms that are difficult to reverse, with an estimated survival time of less than 7 days (3) Patients with deteriorating hemodynamic status who require an increase in the dosage of vasoactive drugs (under comprehensive fluid resuscitation and treatment with 2ug/kg · min or higher doses of norepinephrine, systolic blood pressure<90mmHg, arterial blood pH<7.0) (4) Individuals with known severe cardiovascular, respiratory, renal, liver, and blood system diseases, as well as severe immune dysfunction, malignant tumors, epilepsy, and other diseases (5) Long term use of hormones or immunosuppressive drugs (6) Individuals equipped with a pacemaker or defibrillator (7) The clinical situation of significant intestinal ischemia or obstruction, severe abdominal distension or compartment syndrome, active gastrointestinal bleeding, and high-level gastrointestinal fistula without satisfactory placement of enteral nutrition tubes affecting the treatment of traditional Chinese medicine and enteral nutrition through the gastrointestinal tract (8) Allergic to TCM formula or enteral nutrition (9) Undergone other clinical trials within 6 months prior to the start of the trial (10) Participated in this trial before

Design outcomes

Primary

MeasureTime frame
D5`s compliance rate of enteral nutrition;

Secondary

MeasureTime frame
Enteral nutrition tolerance score;Acute Gastrointestinal Injury Ultrasonography Score;Acute Gastrointestinal Injury grade;Gastrointestinal Dysfunction Score;all-cause mortality;Length of stay in ICU;Length of stay in hospital;Sequential Organ Failure Assessment Score; Acute Physiology and Chronic Health Evaluation II Score;Euroqol 5-dimension 5-level questionnaire(EQ-5D-5L) Score;

Countries

china

Contacts

Public ContactChen Mingzhi

Jinjiang Hospital of Traditional Chinese Medicine

cmz_1973@126.com+86 1396008350

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026