Renalof in the Treatment of Elderly Patients With Gallstones

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

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.

Inclusion Criteria:

• Confirmation of cholelithiasis by ultrasonography with or without clinical symptoms.
• Signed informed consent

Exclusion Criteria:

• Previous surgical intervention for the treatment of cholelithiasis
• Cholelithiasis with acute symptoms requiring emergency surgery
• Cholelithiasis associated with neoplastic condition of any localization or origin
• Usage of other antioxidants within the duration of the clinical trial
• Handicap and/or psychiatric condition preventing treatment accomplishment