An interventional study of Functional fatty acids and Placebo in Gallbladder Stone, sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-12-31.
Sponsored by Hepatopancreatobiliary Surgery Institute of Gansu Province · Not applicable, Interventional, and Treatment
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's planned enrollment of 100 is close to the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Hepatopancreatobiliary Surgery Institute of Gansu Province is the lead sponsor of 44 studies on the registry; 8 are open to participants now.
Compared within Gallstones, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholecystolithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Oral Administration of functional fatty acids
Drug: Functional fatty acids
Oral Administration of Placebo
Other: Placebo
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
Number 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
Time frame: 14 days
Nausea, Vomiting, and Diarrhea Post-Intervention
Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention
Time frame: 14 days
Plan to share: No
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Hepatopancreatobiliary Surgery Institute of Gansu Province