Effect of Rowachol on Prevention of Postcholecystectomy Syndrome

D

DongGuk University

Status and phase

Completed
Phase 4

Conditions

Postcholecystectomy Syndrome

Treatments

Drug: Rowachol
Drug: Placebo

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT01765465
S-2012-E0816-00001

Details and patient eligibility

About

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

Enrollment

138 patients

Sex

All

Ages

18 to 84 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with pathologic diseases scheduled for laparoscopic cholecystectomy

Exclusion criteria

  • Current immunosuppressive therapy
  • Chemotherapy within 4 weeks before operation
  • Radiotherapy completed longer than 4 weeks before operation
  • Inability to follow the instructions given by the investigator
  • Severe psychiatric or neurologic diseases
  • Drug- and/or alcohol-abuse according to local standards
  • Participation in another intervention-trial with interference of a primary or secondary endpoint of this study
  • Lack of compliance
  • Lack of informed consent

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

138 participants in 2 patient groups, including a placebo group

Rowachol
Experimental group
Description:
Rowachol treatment with 200mg PO tid, on postoperative 1 days to 3 months
Treatment:
Drug: Rowachol
Placebo
Placebo Comparator group
Description:
Placebo treatment with 200mg PO tid, on postoperative 1 days to 3 months
Treatment:
Drug: Placebo

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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