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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall Clinical Response Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Overall Clinical Response Rate
时间窗: At the end of the 5-day treatment period
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%.
次要结局
- 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)
- Time to Recovery of Bowel Sounds(From initiation of treatment through hospital discharge, approximately 1 week)
- Time to First Oral Food Intake(From initiation of treatment through hospital discharge, approximately 1 week)
- Change From Baseline in Serum Amylase(Baseline and immediately after completion of the 5-day treatment period)
- Change From Baseline in Urinary Amylase(Baseline and immediately after completion of the 5-day treatment period)
- Change From Baseline in C-Reactive Protein(Baseline and immediately after completion of the 5-day treatment period)
- Change From Baseline in Procalcitonin(Baseline and immediately after completion of the 5-day treatment period)
- Incidence of Adverse Events(From signing informed consent through 7 days after hospital discharge)
研究者
Mengyao Wang
Principal Investigator
The Third Affiliated Hospital of Wenzhou Medical University