Renalof in the Treatment of Elderly Patients With Gallstones

Phase 3

Completed

• Conditions: Cholelithiasis
• Interventions: Dietary Supplement: Renalof; Dietary Supplement: Placebo

• Registration Number: NCT01099319
• Lead Sponsor: Catalysis SL

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-05
• Study First Submitted QC: 2010-04-05
• Study First Posted: 2010-04-06
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-06
• Last Update Posted: 2012-05-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Renalof	Renalof	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
Size of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)	6 month
Number of calculi at month 0 and 6 (month 0 refers to the beginning of treatment and month 6 refers to the end of the treatment)	6 month

Secondary Outcome Measures

Name	Time	Method
Presence of digestive symptoms associated with cholelithiasis	6 month
Occurrence of adverse effects during treatment	6 month

Trial Locations

Locations (1)

"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital; 🇨🇺 Havana City, Havana, Cuba