Tongfu Qinghua Decoction Enema and Ruyi Jinhuang Powder for Acute Pancreatitis

A Clinical Study on the Efficacy of Rectal Administration of Tongfu Qinghua Decoction Combined With External Application of Ruyi Jinhuang Powder in Treating Acute Pancreatitis

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.

Study Overview

• Status: Completed
• Conditions: Acute Pancreatitis
• Intervention / Treatment: Drug: Tongfu Qinghua Decoction Enema; Drug: Ruyi Jinhuang Powder External Application; Other: Conventional Medical Treatment

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Rui’an, Zhejiang, China, 325200
      • Ruian People's Hospital (The Third Affiliated Hospital of Wenzhou Medical University)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tongfu Qinghua Decoction and Ruyi Jinhuang Powder Group; Participants received conventional medical treatment for acute pancreatitis together with Tongfu Qinghua Decoction administered by enema and Ruyi Jinhuang Powder applied externally. The herbal enema was administered once daily for up to 5 consecutive days. Ruyi Jinhuang Powder was applied over the Shenque acupoint and the surrounding area twice daily, with each application maintained for approximately 4 hours. Conventional medical treatment was provided throughout the treatment period.	Drug: Tongfu Qinghua Decoction Enema; Tongfu Qinghua Decoction contained rhubarb 10 g, mirabilite 10 g, Magnolia officinalis bark 10 g, fried immature bitter orange 10 g, dandelion 30 g, Patrinia herb 30 g, Polygonum cuspidatum 30 g, honeysuckle 15 g, and Salvia miltiorrhiza 20 g. Prespecified syndrome-based modifications were permitted. The herbs were centrally decocted by the hospital pharmacy and concentrated to approximately 200 mL. The decoction was cooled to 38-40 degrees Celsius and administered slowly through a rectal tube inserted approximately 15-20 cm, with the participant in the left lateral position. Participants retained the solution for approximately 30 minutes. Treatment was administered once daily for up to 5 consecutive days and could be stopped earlier if symptoms resolved, spontaneous bowel movements occurred, or diarrhea developed.; Drug: Ruyi Jinhuang Powder External Application; Ruyi Jinhuang Powder, manufactured by Jiangsu 707 Natural Pharmaceutical Co., Ltd., was mixed with water or tea to form a paste and spread onto gauze. The prepared dressing was externally applied over the Shenque acupoint (CV8) and the surrounding area extending approximately 3-5 cm. The dressing was secured with adhesive tape and removed after approximately 4 hours. The intervention was administered twice daily for 5 consecutive days.; Other: Conventional Medical Treatment; Conventional medical treatment for acute pancreatitis was provided according to the participant's clinical condition. Treatment included restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid resuscitation, nutritional support, inhibition of pancreatic secretion, and anti-infective treatment when indicated. Analgesic and antispasmodic medications were administered for symptomatic relief when necessary. The treatment course was 5 days.
Active Comparator: Conventional Medical Treatment Group; Participants received conventional medical treatment for acute pancreatitis for 5 days. Treatment included restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid and nutritional support, inhibition of pancreatic secretion, anti-infective treatment when indicated, and analgesic or antispasmodic treatment for symptomatic relief when necessary.	Other: Conventional Medical Treatment; Conventional medical treatment for acute pancreatitis was provided according to the participant's clinical condition. Treatment included restriction of oral food and fluids when clinically required, gastrointestinal decompression, fluid resuscitation, nutritional support, inhibition of pancreatic secretion, and anti-infective treatment when indicated. Analgesic and antispasmodic medications were administered for symptomatic relief when necessary. The treatment course was 5 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Clinical Response Rate	Percentage of participants who achieved complete cure, marked response, or response after the 5-day treatment period. Complete cure was defined as disappearance of clinical symptoms and signs within 5 days, together with normalization of relevant laboratory indicators. Marked response was defined as disappearance of clinical symptoms and signs within 5 days, together with substantial improvement in laboratory indicators. Response was defined as improvement in clinical symptoms, signs, and laboratory indicators within 5 days. No response was defined as no improvement or worsening of clinical symptoms and signs. Death due to deterioration of acute pancreatitis was not counted as a clinical response. The overall clinical response rate was calculated as: (number of participants with complete cure + marked response + response) / total number of participants assessed × 100%.	At the end of the 5-day treatment period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of Hospital Stay	Number of days from hospital admission to hospital discharge.	From hospital admission through discharge, approximately 1 week
Time to Abdominal Pain Relief	Number of days from initiation of the assigned treatment to the first documented relief of abdominal pain, as assessed and recorded by the study investigators.	From initiation of treatment through hospital discharge, approximately 1 week
Time to Abdominal Distension Relief	Number of days from initiation of the assigned treatment to the first documented relief of abdominal distension.	From initiation of treatment through hospital discharge, approximately 1 week
Time to First Passage of Flatus	Number of days from initiation of the assigned treatment to the participant's first documented passage of flatus.	From initiation of treatment through hospital discharge, approximately 1 week
Time to First Bowel Movement	Number of days from initiation of the assigned treatment to the participant's first documented bowel movement.	From initiation of treatment through hospital discharge, approximately 1 week
Time to Recovery of Bowel Sounds	Number of days from initiation of the assigned treatment to the first documented recovery of bowel sounds on clinical examination.	From initiation of treatment through hospital discharge, approximately 1 week
Time to First Oral Food Intake	Number of days from initiation of the assigned treatment to the participant's first documented oral food intake permitted according to clinical recovery.	From initiation of treatment through hospital discharge, approximately 1 week
Change From Baseline in Serum Amylase	Serum amylase was measured in fasting venous blood and reported in units per liter (U/L). Change from baseline was calculated as the post-treatment value minus the baseline value.	Baseline and immediately after completion of the 5-day treatment period
Change From Baseline in Urinary Amylase	Urinary amylase was measured using a midstream clean urine sample and reported in units per liter (U/L). Change from baseline was calculated as the post-treatment value minus the baseline value.	Baseline and immediately after completion of the 5-day treatment period
Change From Baseline in C-Reactive Protein	Serum C-reactive protein was measured in fasting venous blood and reported in milligrams per liter (mg/L). Change from baseline was calculated as the post-treatment value minus the baseline value.	Baseline and immediately after completion of the 5-day treatment period
Change From Baseline in Procalcitonin	Serum procalcitonin was measured in fasting venous blood and reported in micrograms per liter (µg/L). Change from baseline was calculated as the post-treatment value minus the baseline value.	Baseline and immediately after completion of the 5-day treatment period
Incidence of Adverse Events	Percentage of participants who experienced at least one adverse event during the observation period. 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 follow-up assessments.	From signing informed consent through 7 days after hospital discharge

Collaborators and Investigators

• Sponsor: The Third Affiliated Hospital of Wenzhou Medical University

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2023
• Primary Completion (Actual): August 30, 2025
• Study Completion (Actual): September 1, 2025

Study Registration Dates

• First Submitted: July 14, 2026
• First Submitted That Met QC Criteria: July 14, 2026
• First Posted (Actual): July 17, 2026

Study Record Updates

• Last Update Posted (Actual): July 17, 2026
• Last Update Submitted That Met QC Criteria: July 14, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Traditional Chinese Medicine; Gastrointestinal Function; Tongfu Qinghua Decoction; Ruyi Jinhuang Powder; Rectal Administration; Traditional Chinese Medicine Enema; External Application; Integrated Chinese and Western Medicine
• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis
• Other Study ID Numbers: RAH-AP-TFQH-RJHP-2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• IPD Sharing Access Criteria: 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No