This study is a double-blind, prospective, single-center controlled trial conducted at a tertiary hospital, aiming to determine whether dietary therapy can effectively expel gallstones.
Gallstones are a common clinical condition, and their prevalence has been increasing globally in recent years. Gallstone formation is a result of various combined factors, and in its early stages, gallstones often exist in a sludge-like form. Currently, there is no definitive research on whether gallbladder sludge can be effectively expelled through medication or dietary therapy. Therefore, the investigators are conducting a double-blind, prospective, single-center controlled trial to verify whether gallbladder sludge-like stones can be effectively expelled using dietary therapy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
100
Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids
Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids
Long Deng
Lanzhou, Gansu, China
RECRUITINGNumber of patients with complete expulsion of gallbladder sludge after three days of intervention
Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
Time frame: 7 days
2）Number of patients with complete expulsion of gallbladder sludge after six days of intervention
Determined by ultrasound examination before and after the intervention to assess whether gallbladder sludge has been fully expelled
Time frame: 7 days
Gallbladder Volume
Measured by ultrasound (L × W × D × 0.52)
Time frame: 7 days
Gallbladder Wall Thickness
Measured by ultrasound, accurate to 0.1 mm
Time frame: 7 days
Serum bilirubin
Determined by lab examination within 3.4-17.1μmol/L
Time frame: 7 days
Presence of Abdominal Pain Post-Intervention
If abdominal pain is present, it will be assessed using the Numerical Rating Scale (NRS) within 0-10, The higher the score, the more serious it is
Time frame: 7 days
Occurrence of Acute Pancreatitis Post-Intervention
Pain and Amy \>3times as normal
Time frame: 14 days
Occurrence of Gastrointestinal Bleeding Post-Intervention
Black stool or decrease of HB
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Time frame: 14 days
Nausea, Vomiting, and Diarrhea Post-Intervention
Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention
Time frame: 14 days