Tongfu Qinghua Decoction Enema and Ruyi Jinhuang Powder for Acute Pancreatitis

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

Interventions

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.

Sponsors & Collaborators

• The Third Affiliated Hospital of Wenzhou Medical University

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-10-01

Primary Completion

2025-08-30

Completion

2025-09-01

Countries

• China

Study Locations