Acute pancreatitis abdominal pain
Conditions
Interventions
Test group:Liuhe Dan ointment for external use. 20g~40g once (equivalent to 1-2 doses), once a day, evenly apply and cover the entire affected area according to the patients abdominal and lumbar condi
Control group:Liuhedan ointment simulator for external use. 20g~40g once (equivalent to 1-2 doses), once a day, evenly apply and cover the entire affected area according to the patients abdominal and
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age range from 18 to 65 years old (including 18 and 65 years old), regardless of gender; (2) Meets the diagnostic criteria for moderate to severe acute pancreatitis; (3) Symptoms of abdominal pain were present during screening and randomization, with a score of 3 = VAS score of abdominal pain = 8; (4) Disease duration = 14 days; (5) Agree to participate in this clinical trial and voluntarily sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Known or suspected to be allergic to the components of the investigational drug, or allergic constitution. (2) Known or suspected allergic reactions to the components of the corresponding acute analgesic drug tramadol hydrochloride injection. (3) Combined with other diseases that cause abdominal pain, such as gastrointestinal perforation, severe cholecystitis, biliary obstruction, purulent cholangitis, etc. (4) Within the first week of screening, other abdominal topical preparations such as diclofenac diethylamine emulsion and mirabilite were used. (5) ALT, AST = 1.5 times the upper limit of normal value, and SCr>the upper limit of normal value. (6) Have a history of any of the following serious cardiovascular and cerebrovascular diseases: ? Has experienced unstable angina or undergone coronary artery bypass grafting surgery or percutaneous coronary intervention within 3 months prior to the first administration. ? Myocardial infarction, shock, or life-threatening arrhythmia occurred within 6 months prior to the first administration. ? History of left ventricular outflow tract obstruction (such as aortic stenosis, idiopathic hypertrophic subvalvular aortic stenosis). ? When screening, heart failure = grade II (NYHA classification standard). ? Acute stroke occurred within 6 months prior to the first administration, excluding asymptomatic stroke. (7) Uncontrolled/poorly controlled hypertension (hypertension history at screening, regular medication treatment, blood pressure measured twice in succession at screening = 160/100mmHg), or poorly controlled diabetes (diabetes history at screening, regular medication treatment, random blood glucose = 11.1 mmol/L or fasting blood glucose = 7.0 mmol/L). (8) Unable to cooperate or unwilling to cooperate due to neurological or psychiatric disorders. (9) Merge legally defined disabilities (blind, deaf, mute, intellectual disabilities, mental disorders, etc.). (10) Suspect or confirm a long-term history of drug or drug abuse. (11) Pregnant women, lactating women, or those with recent fertility plans. (12) Have participated in other intervention clinical trials within the past three months. (13) The researchers believe that they cannot participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time for disappearance of abdominal pain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in VAS scores of abdominal pain at 1h, 2h, 4h, and 6h within the first 6 hours of application compared to before the first application;Changes in VAS score of abdominal pain before and after daily application on the second and third day of medication;The disappearance rate of abdominal pain on the 5th, 7th, 10th, and 14th day of medication;During the experiment, if the subject experiences swelling in the lumbar and rib regions, the changes in subcutaneous tissue measurements (thickness of the lumbar and rib skin and subcutaneous tissue) compared to baseline on the 4th, 7th, or 1st day before discharge from the abdominal wall superficial color ultrasound will be evaluated;Changes in inflammatory markers (CRP, IL-6) compared to baseline on the 3rd, 7th, and 14th day of medication;Hospitalization days;Eating time;Frequency and dosage of emergency analgesics use; | — |
Countries
China
Contacts
Public ContactQing Xia/ Shen Qi
West China Hospital of Sichuan University
Outcome results
None listed