Trials / Unknown
UnknownNCT03578055
BDD With UDCA Therapy After Laparoscopic Cholecystectomy
Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 172 (estimated)
- Sponsor
- Ewha Womans University Mokdong Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
Prospective Study for the Effects of Biphenyl Dimethyl Dicarboxylate and Ursodeoxycolic Acid Therapy on Liver Function and Quality of Life After Laparoscopic Cholecystectomy Primary endpoint: peak level of postoperative AST (aspartate transaminase) and postoperative ALT (alanine tansaminase) Secondary endpoint: postoperative GIQLI (Gastrointestinal Quality of Life index) score
Detailed description
Because the gallbladder is adjacent to the liver, liver enzymes are often elevated when cholecystitis occurs. BDD and UDCA drugs are known to be effective in preserving liver function. The use of BDD and UDCA drugs in patients with cholecystitis is expected to inhibit elevated liver enzyme levels and to maintain liver function. The aim of this study is to analyze the effects of BDD and UDCA medication on postoperative changes in hepatic enzyme levels and quality of life in patients LFT elevated cholecystitis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | BDD with UDCA | Dosage: Udex 1 capsule, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery |
| DRUG | Placebo | Dosage: 1 capsule of placebo, 3 times daily Time of administration: 30 minutes after meal Duration of administration: From the day before surgery to 4 weeks after surgery |
Timeline
- Start date
- 2018-04-24
- Primary completion
- 2019-11-30
- Completion
- 2019-12-31
- First posted
- 2018-07-05
- Last updated
- 2018-07-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT03578055. Inclusion in this directory is not an endorsement.