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Tongfu Qinghua Decoction Enema and Ruyi Jinhuang Powder for Acute Pancreatitis
Sponsor: The Third Affiliated Hospital of Wenzhou Medical University
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.
Official title: 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
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
100
Start Date
2023-10-01
Completion Date
2025-09-01
Last Updated
2026-07-17
Healthy Volunteers
No
Conditions
Interventions
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.
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.
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.
Locations (1)
Ruian People's Hospital (The Third Affiliated Hospital of Wenzhou Medical University)
Rui’an, Zhejiang, China