Acute pancreatitis is an inflammatory condition that commonly causes abdominal pain, abdominal distension, impaired gastrointestinal function, and elevated pancreatic and inflammatory biomarkers. Although conventional medical treatment can stabilize most patients, recovery of gastrointestinal function and relief of local inflammation may remain slow.

This completed, single-center, randomized controlled study evaluated whether adding Tongfu Qinghua Decoction administered by enema and Ruyi Jinhuang Powder applied externally to conventional medical treatment could improve clinical recovery in adults with acute pancreatitis.

A total of 100 participants aged 18 to 75 years were randomly assigned in a 1:1 ratio to receive either conventional medical treatment alone or conventional medical treatment combined with Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder. Both groups received treatment for 5 days.

The study evaluated overall clinical response, length of hospital stay, time to relief of abdominal pain and abdominal distension, recovery of bowel function, time to first food intake, serum and urinary amylase levels, C-reactive protein, procalcitonin, and treatment-related adverse events.

Acute pancreatitis is an acute inflammatory disease caused by abnormal activation of pancreatic enzymes, resulting in injury to the pancreas and surrounding tissues. Patients may experience abdominal pain, abdominal distension, reduced bowel motility, delayed passage of flatus and stool, and systemic inflammatory responses. Conventional management generally includes fasting, gastrointestinal decompression, fluid and nutritional support, inhibition of pancreatic secretion, anti-infective treatment when clinically indicated, and symptomatic treatment. However, gastrointestinal dysfunction and inflammatory responses may persist in some patients.

This study was designed to evaluate the efficacy and safety of Tongfu Qinghua Decoction administered by enema combined with external application of Ruyi Jinhuang Powder as an adjunct to conventional medical treatment in patients with acute pancreatitis.

This was a single-center, prospective, randomized, parallel-group clinical study conducted at Ruian People's Hospital. A total of 100 eligible participants were randomly assigned in a 1:1 ratio to an experimental group or a control group, with 50 participants in each group. Randomization was performed using a computer-generated random number table. Allocation information was placed in sequentially numbered, sealed, opaque envelopes, which were opened after eligibility confirmation and written informed consent.

Participants in the control group received conventional medical treatment, including restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid resuscitation, nutritional support, inhibition of pancreatic secretion, anti-infective treatment, and analgesic or antispasmodic therapy when necessary.

Participants in the experimental group received the same conventional medical treatment together with Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder.

Tongfu Qinghua Decoction was centrally prepared by the hospital's Traditional Chinese Medicine pharmacy. The core formula contained rhubarb, mirabilite, Magnolia officinalis bark, fried immature bitter orange, dandelion, Patrinia herb, Polygonum cuspidatum, honeysuckle, and Salvia miltiorrhiza. Prespecified modifications could be made according to the participant's traditional Chinese medicine syndrome manifestations.

The concentrated decoction was prepared to a volume of approximately 200 mL and cooled to 38 to 40 degrees Celsius before administration. With the participant positioned in the left lateral position, a lubricated rectal tube was inserted approximately 15 to 20 cm, and the decoction was administered slowly. Participants were instructed to retain the solution for approximately 30 minutes. The enema was administered once daily for up to 5 consecutive days. Administration could be discontinued earlier if abdominal pain and distension resolved, spontaneous bowel movements recovered, or diarrhea developed.

Ruyi Jinhuang Powder was mixed with water or tea to form a paste, applied to gauze, and placed over the Shenque acupoint and the surrounding 3 to 5 cm area. The application was secured with adhesive tape and removed after approximately 4 hours. It was administered twice daily for 5 days.

The primary clinical assessment was the overall treatment response after the 5-day treatment period. Clinical response was categorized according to changes in symptoms, signs, and laboratory indicators.

Additional assessments included length of hospital stay; time to relief of abdominal pain and abdominal distension; time to first passage of flatus; time to first bowel movement; time to recovery of bowel sounds; and time to first food intake.

Serum amylase and urinary amylase were measured before treatment and after completion of the treatment course to assess changes in pancreatic inflammatory activity. Serum C-reactive protein and procalcitonin were also measured before and after treatment to evaluate systemic inflammatory responses.

Adverse events of interest included gastrointestinal bleeding, dizziness, headache, gastrointestinal discomfort, skin rash, and perianal redness or swelling. Adverse events were collected through participant reporting, daily clinical observation, and structured assessment on treatment days 1, 3, and 5, at discharge, and 7 days after discharge.

Because the enema and external application procedures were readily identifiable, complete blinding of participants, treating clinicians, and outcome assessors was not feasible. To reduce assessment bias, outcome assessors received standardized training, data were recorded using a standardized electronic case report form, assessments were independently cross-checked by two researchers, and disagreements were reviewed by a senior clinician. Treatment-group information was concealed during data entry and statistical analysis where feasible.

Inclusion Criteria:

• Diagnosis of acute pancreatitis according to established clinical diagnostic criteria.
• Age 18 to 75 years.
• First episode of acute pancreatitis with no treatment received before enrollment.
• Voluntary participation and provision of written informed consent.

Exclusion Criteria:

• Presence of an indication for surgical intervention.
• Pre-existing severe gastrointestinal disease.
• Significant organ dysfunction or another severe underlying disease.
• Pregnancy or breastfeeding.
• A mental or psychiatric condition that prevented effective participation in the study.
• Any contraindication to traditional Chinese medicine enema treatment.

De-identified individual participant data underlying the results reported in the published article will be shared. The shared data may include demographic and baseline characteristics, treatment allocation, clinical response categories, hospitalization duration, symptom recovery times, serum and urinary amylase levels, C-reactive protein and procalcitonin levels, and adverse event information. Direct identifiers and information that could reasonably identify individual participants will not be shared.

Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.

De-identified data will be available to qualified researchers who submit a methodologically sound research proposal. Requests will be reviewed by the principal investigator and the institutional research team. Access will be granted for approved scientific purposes after completion of a data use agreement and confirmation that the proposed use complies with participant confidentiality requirements, applicable ethical approvals, and institutional data management policies. Requests should be submitted to Qingmiao189066@yeah.net.

This was an open-label study. Because the Tongfu Qinghua Decoction enema and external application of Ruyi Jinhuang Powder were readily identifiable, participants, care providers, investigators, and outcome assessors were not blinded to treatment assignment. To reduce assessment bias, standardized outcome definitions and electronic case report forms were used, assessments were independently cross-checked, and group information was concealed during data entry and statistical analysis where feasible.