Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Pharmbio Korea Co., Ltd. | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Postcholecystectomy syndrome (PCS) includes a heterogeneous group of diseases, usually manifested by the presence of abdominal symptoms following gallbladder removal. The pathogenesis of PCS has not been identified; therefore there is no consensus of medical treatment on PCS. The Action of Rowachol are to inhibit hepatic 3-hydroxy-3-methylglutaric acid(HMG)-coenzyme A(CoA) reductase, to inhibits cholesterol nucleation in bile from patients with cholesterol gallstones, and to promote biliary lipid secretion.
The purpose of this study is to determine whether Rowachol is useful in the prevention of PCS and symptoms change after laparoscopic cholecystectomy
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rowachol | Experimental | Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months |
|
| Placebo | Placebo Comparator | Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rowachol | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| the Number of the Participants Have Postoperative RUQ Pain | Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month. The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual. The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results. | postoperative 3-month |
| Measure | Description | Time Frame |
|---|---|---|
| Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | postoperative 3-month |
| Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| In Woong Han, M.D. | DongGuk University College of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DongGuk University Ilsan Hospital | Goyang-si | Gyeonggi-do | 410-773 | South Korea | ||
| Chung-Ang University Hospital |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Rowachol | Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol |
| FG001 | Placebo | Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Rowachol | Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol |
| BG001 | Placebo | Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | the Number of the Participants Have Postoperative RUQ Pain | Right upper quadrant(RUQ) pain by European Organization for Research and Treatment of Cancer(EORTC) quality of life questionnaire(QLQ) C-30 No. 9, 19 at baseline and postoperative 3-month. The pain score of individuals at postoperative 3-month is calculated by EORTC QLQ C-30 manual. The pain score range is 0 to 100. Higher score means participants feel more pain(worse). If a participant's pain score is over 30, we define he/she has post operative RUQ pain. we use the number of the participants have post operative RUQ pain(score over 30) as the results. | Posted | Number | number of participants | postoperative 3-month |
|
postoperative 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Rowachol | Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months Rowachol |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Post operative minor bile leak | Hepatobiliary disorders | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. In Woong Han | DongGuk University Ilsan Hospital | cardioman76@gmail.com |
Not provided
| ID | Term |
|---|---|
| D017562 | Postcholecystectomy Syndrome |
| ID | Term |
|---|---|
| D001660 | Biliary Tract Diseases |
| D004066 | Digestive System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
Not provided
Not provided
| ID | Term |
|---|---|
| C018655 | Rowachol |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. |
| postoperative 3-month |
| Laboratory Test Results of Postoperative 3-month(WBC Count) | laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | postoperative 3-month |
| Seoul |
| 156-755 |
| South Korea |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Placebo |
Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo |
|
|
| Secondary | Laboratory Test Results of Postoperative 3-month(Total Bilirubin, Direct Bilirubin) | laboratory test results(liver function test such as total bilirubin, direct bilirubin) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | Posted | Mean | Standard Deviation | mg/dL | postoperative 3-month |
|
|
|
| Secondary | Laboratory Test Results of Postoperative 3-month(Alkaline Phosphatase, Aspartate Aminotransferase, Alanine Aminotransferase) | laboratory test results(liver function test such as Alkaline phosphatase, Aspartate aminotransferase, Alanine aminotransferase) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | Posted | Mean | Standard Deviation | IU/dL | postoperative 3-month |
|
|
|
| Secondary | Laboratory Test Results of Postoperative 3-month(WBC Count) | laboratory test results(WBC count) measured at postoperative 3-month of Rowachol group and placebo group. each result is mean values. | Posted | Mean | Standard Deviation | cells (10^6/µl) | postoperative 3-month |
|
|
|
| 0 |
| 64 |
| 0 |
| 64 |
| EG001 | Placebo | Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months Placebo | 0 | 63 | 1 | 63 |
Not provided
Not provided
| D013568 | Pathological Conditions, Signs and Symptoms |
| Alanine aminotransferase |
|