Renalof in the Treatment of Elderly Patients With Gallstones

May 6, 2012 updated by: Catalysis SL

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Cuba
    • Havana
      • Havana City, Havana, Cuba
        • "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Dietary supplement: Placebo
One Placebo tablet (Orally administered) every 8 hours, for 6 months
Experimental: Renalof
Dietary supplement: Renalof
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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)
Time Frame: 6 month
6 month

Secondary Outcome Measures

Outcome Measure
Time Frame
Presence of digestive symptoms associated with cholelithiasis
Time Frame: 6 month
6 month
Occurrence of adverse effects during treatment
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Catalysis SL

Investigators

  • Principal Investigator: Guillermo Hernández Mojena, MD, "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

June 1, 2011

Study Completion (Actual)

June 1, 2011

Study Registration Dates

First Submitted

April 5, 2010

First Submitted That Met QC Criteria

April 5, 2010

First Posted (Estimate)

April 6, 2010

Study Record Updates

Last Update Posted (Estimate)

May 8, 2012

Last Update Submitted That Met QC Criteria

May 6, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAT-1001-CU

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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