Renalof in the Treatment of Elderly Patients With Gallstones

• Sponsor: Catalysis SL (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01099319
• Collaborator: (none)
• Enrollment: 40
• Location: 1
• Arms: 2
• Duration (Months): 17
• Patients Per Site Per Month: 2.4

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Cholelithiasis	Dietary Supplement: Renalof; Dietary Supplement: Placebo	Phase 3

Study Design

• Study Type: Interventional
• 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: Jan 1, 2010
• Actual Primary Completion Date: Jun 1, 2011
• Actual Study Completion Date: Jun 1, 2011

Arms and Interventions

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

Outcome Measures

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) [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) [6 month]

Secondary Outcome Measures

1. Presence of digestive symptoms associated with cholelithiasis [6 month]

2. Occurrence of adverse effects during treatment [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	"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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Catalysis SL
• ClinicalTrials.gov Identifier: NCT01099319
• Other Study ID Numbers: CAT-1001-CU
• First Posted: Apr 6, 2010
• Last Update Posted: May 8, 2012
• Last Verified: May 1, 2012

• Keywords provided by Catalysis SL: Dietary supplement; Renalof; gallstones; elderly
• Additional relevant MeSH terms: Gallstones; Cholelithiasis; Cholecystolithiasis

Study Results

No Results Posted as of May 8, 2012