Back to resultsRenalof in the Treatment of Elderly Patients With Gallstones
Primary Purpose
Cholelithiasis
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Renalof
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Cholelithiasis focused on measuring Dietary supplement, Renalof, gallstones, elderly
Eligibility Criteria
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
Sites / Locations
- "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Renalof
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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)
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)
Secondary Outcome Measures
Presence of digestive symptoms associated with cholelithiasis
Occurrence of adverse effects during treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01099319
Brief Title
Renalof in the Treatment of Elderly Patients With Gallstones
Official Title
Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholelithiasis
Keywords
Dietary supplement, Renalof, gallstones, elderly
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Renalof
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Renalof
Intervention Description
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
One Placebo tablet (Orally administered) every 8 hours, for 6 months
Primary Outcome Measure Information:
Title
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)
Time Frame
6 month
Title
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)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Presence of digestive symptoms associated with cholelithiasis
Time Frame
6 month
Title
Occurrence of adverse effects during treatment
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guillermo Hernández Mojena, MD
Organizational Affiliation
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
City
Havana City
State/Province
Havana
Country
Cuba
12. IPD Sharing Statement
Learn more about this trial
Renalof in the Treatment of Elderly Patients With Gallstones
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