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Renalof in the Treatment of Elderly Patients With Gallstones

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ClinicalTrials.gov Identifier: NCT01099319
Recruitment Status : Completed
First Posted : April 6, 2010
Last Update Posted : May 8, 2012
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cholelithiasis Dietary Supplement: Renalof Dietary Supplement: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones
Study Start Date : January 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gallstones

Arm Intervention/treatment
Experimental: Renalof Dietary Supplement: Renalof
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.

Placebo Comparator: Placebo Dietary Supplement: Placebo
One Placebo tablet (Orally administered) every 8 hours, for 6 months




Primary Outcome Measures :
  1. 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 ]
  2. 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 Measures :
  1. Presence of digestive symptoms associated with cholelithiasis [ Time Frame: 6 month ]
  2. Occurrence of adverse effects during treatment [ Time Frame: 6 month ]


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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01099319


Locations
Cuba
"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital
Havana City, Havana, Cuba
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Guillermo Hernández Mojena, MD "Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Responsible Party: Catalysis SL
ClinicalTrials.gov Identifier: NCT01099319     History of Changes
Other Study ID Numbers: CAT-1001-CU
First Posted: April 6, 2010    Key Record Dates
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Catalysis SL:
Dietary supplement
Renalof
gallstones
elderly

Additional relevant MeSH terms:
Gallstones
Cholelithiasis
Cholecystolithiasis
Biliary Tract Diseases
Digestive System Diseases
Gallbladder Diseases
Calculi
Pathological Conditions, Anatomical