NCT01099319

Renalof in the Treatment of Elderly Patients With Gallstones

Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Catalysis SL · Industry
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the efficacy and safety of Renalof administration in the treatment of gallstones (cholelithiasis) as determined by ultrasonography and clinical evaluation in elderly patients (aged \>65 years). The duration of this double-blind placebo controlled phase 3 clinical trial will be 6 months. The estimated number of patients to be recruited and randomized for the study is 40.

Conditions

• Cholelithiasis

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Renalof	One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
DIETARY_SUPPLEMENT	Placebo	One Placebo tablet (Orally administered) every 8 hours, for 6 months

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-06-01
• Completion: 2011-06-01
• First posted: 2010-04-06
• Last updated: 2012-05-08

Locations

1 site across 1 country: Cuba