Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Functional fatty acids | Experimental | Oral Administration of functional fatty acids |
|
| Placebo | Placebo Comparator | Oral Administration of Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional fatty acids | Drug | Days 1-3: Oral Administration of functional fatty acids Days 4-6: Oral Administration of functional fatty acids |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| Gallbladder Volume | Measured by ultrasound (L × W × D × 0.52) | 7 days |
| Gallbladder Wall Thickness | Measured by ultrasound, accurate to 0.1 mm |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wenbo Meng, M.D. | Contact | 13919177177 | mengwb@lzu.edu.cn | |
| Long Deng, M.D. | Contact | 13893192432 | ldyy_longdengld@lzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wenbo Meng, M.D. | Hepatopancreatobiliary Surgery Institute of Gansu Province | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Long Deng | Recruiting | Lanzhou | Gansu | 730000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35445045 | Background | Zhuang Q, Cheng J, Xia J, Ning M, Wu S, Shen S, Shi Y, Huang D, Dong Z, Wan X. Gypenosides Prevent and Dissolve Cholesterol Gallstones by Modulating the Homeostasis of Cholesterol and Bile Acids. Front Med (Lausanne). 2022 Apr 4;9:818144. doi: 10.3389/fmed.2022.818144. eCollection 2022. | |
| 35704084 | Background |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D041761 | Cholecystolithiasis |
| D042882 | Gallstones |
| D002764 | Cholecystitis |
| ID | Term |
|---|---|
| D002769 | Cholelithiasis |
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D005705 | Gallbladder Diseases |
Not provided
Not provided
Parallel Assignment
Not provided
Not provided
Double (Investigator, Participant)
| Placebo | Other | Days 1-3: Placebo Days 4-6: Oral Administration of functional fatty acids |
|
| 7 days |
| Serum bilirubin | Determined by lab examination within 3.4-17.1μmol/L | 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 | 7 days |
| Occurrence of Acute Pancreatitis Post-Intervention | Pain and Amy >3times as normal | 14 days |
| Occurrence of Gastrointestinal Bleeding Post-Intervention | Black stool or decrease of HB | 14 days |
| Nausea, Vomiting, and Diarrhea Post-Intervention | Frequency of Nausea, Vomiting, and Diarrhea Post-Intervention | 14 days |
| Mulliri A, Menahem B, Alves A, Dupont B. Ursodeoxycholic acid for the prevention of gallstones and subsequent cholecystectomy after bariatric surgery: a meta-analysis of randomized controlled trials. J Gastroenterol. 2022 Aug;57(8):529-539. doi: 10.1007/s00535-022-01886-4. Epub 2022 Jun 15. |
| D002137 |
| Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |