liver and gallbladder damp-heat type hypochondriac pain(gallbladder stone disease)
Conditions
Interventions
Control group:Orally take simulator of Dachaihu decoction combined with Sijin powder (placebo) for 4 weeks
Experimental group:Orally take Dachaihu decoction combined with Sijin powder for 4 weeks
Sponsors
DongFang hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study a subject must meet all of the following criteria: 1) Diagnosed as gallbladder stone disease with ultrasonography within 2 months. 2) TCM syndrome differentiation belongs to the syndrome of liver and gallbladder damp-heat type. 3) Age is ranged between 18 and 65 years old regardless of gender. 4) Have had hypochondriac pain in the last 1-2 weeks. 5) Voluntarily signed informed consent and could cooperate with corresponding treatment and follow-up.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: 1) Diagnosed as choledocholithiasis acute cholecystitis (acute simple cholecystitis acute suppurative cholecystitis acute gangrenous cholecystitis acute obstructive suppurative cholecystitis etc.) gallbladder perforation complicated with peritonitis and biliary pancreatitis required ERCP or even other surgical intervention. 2) Intake of drugs related to the treatment of this disease or drugs affecting gallbladder functions including antibiotics ursodeoxycholic acid etc. within 2 weeks before randomization. 3) Axillary temperature = 38.5?; WBC = 1.2 times above the upper limit of normal. 4) Abnormal liver function (ALT and AST= 1.5 times above the upper limit of normal value); Abnormal renal function (Urea Cre). 5) Total loss of gallbladder function. 6) Previous complications of intrahepatic bile duct stones digestive tract tumors digestive tract ulcers atrophic gastritis or severe superficial gastritis chronic hepatitis hiatal hernia and chronic pancreatitis. 7) Severe circulatory respiratory digestive urinary endocrine blood system diseases or (and) mental illness. 8) Allergic physique constitution or being allergic to the drugs used in this study. 9) Alcohol and drug abusers (alcohol standards: =50g per day for men =30g per day for women; Substance abuse is determined by clinical symptoms). 10) Pregnant or lactating women(Female subjects are required to use contraception). 11) Enrollment in other clinical study within the last 3 months before screening. 12) Other conditions deemed unsuitable for inclusion by the researchers.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Visual analogue scale of hypochondriac pain;TCM syndrome score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Epigastrial CT scan;safety examination;blood biochemical examination;Ultrasonography of gallbladder; | — |
Countries
China
Contacts
Public ContactShi-rui
DongFang hospital of Beijing University of Chinese Medicine
Outcome results
None listed