Tongfu Qinghua Decoction Enema and Ruyi Jinhuang Powder for Acute Pancreatitis

NCT07712081 | Completed

• 1 other identifier: RAH-AP-TFQH-RJHP-2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acute Pancreatitis

Keywords

Tongfu Qinghua Decoction; Ruyi Jinhuang Powder; Traditional Chinese Medicine; Rectal Administration; Traditional Chinese Medicine Enema; External Application; Integrated Chinese and Western Medicine; Gastrointestinal Function

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Length of Hospital Stay

  From hospital admission through discharge, approximately 1 week

• Time to Abdominal Pain Relief

  From initiation of treatment through hospital discharge, approximately 1 week

• Time to Abdominal Distension Relief

  From initiation of treatment through hospital discharge, approximately 1 week

• Time to First Passage of Flatus

  From initiation of treatment through hospital discharge, approximately 1 week

• Time to First Bowel Movement

  From initiation of treatment through hospital discharge, approximately 1 week

Study Arms (2)

Tongfu Qinghua Decoction and Ruyi Jinhuang Powder Group

EXPERIMENTAL

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; Drug: Ruyi Jinhuang Powder External Application; Other: Conventional Medical Treatment

Conventional Medical Treatment Group

ACTIVE COMPARATOR

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

Interventions

Tongfu Qinghua Decoction Enema DRUG

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.

Tongfu Qinghua Decoction and Ruyi Jinhuang Powder Group

Conventional Medical Treatment OTHER

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.

Conventional Medical Treatment Group; Tongfu Qinghua Decoction and Ruyi Jinhuang Powder Group

Ruyi Jinhuang Powder External Application DRUG

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.

Tongfu Qinghua Decoction and Ruyi Jinhuang Powder Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Wenzhou Medical University: lead

Study Sites (1)

Ruian People's Hospital (The Third Affiliated Hospital of Wenzhou Medical University)

Rui’an, Zhejiang, 325200, China

Location

MeSH Terms

Conditions

Pancreatitis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: This was a two-arm, randomized, parallel-group controlled study. Participants were 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 for 5 days.

Study Record Dates

• First Submitted: July 14, 2026
• First Posted: July 17, 2026
• Study Start: October 1, 2023
• Primary Completion: August 30, 2025
• Study Completion: September 1, 2025
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Data will become available beginning 6 months after publication of the primary study results and will remain available for 5 years.
• 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.

Locations

CN (1)