Renalof in the Treatment of Elderly Patients With Gallstones

Cholelithiasis Clinical Trial

Official title:

Efficacy and Safety of Renalof Administration in the Treatment of Elderly Patients With Gallstones

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01099319
• Other study ID #: CAT-1001-CU
• Status: Completed
• Phase: Phase 3
• First received: April 5, 2010
• Last updated: May 6, 2012
• Start date: January 2010
• Est. completion date: June 2011

Study information

• Verified date: May 2012
• Source: Catalysis SL
• Contact: n/a
• Is FDA regulated: No
• Health authority: Cuba: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cholecystolithiasis
• Cholelithiasis
• Gallstones

Intervention

Dietary Supplement:
• Renalof
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
• Placebo
One Placebo tablet (Orally administered) every 8 hours, for 6 months

Locations

Country	Name	City	State
Cuba	"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital	Havana City	Havana

Sponsors (1)

Lead Sponsor	Collaborator
Catalysis SL

Country where clinical trial is conducted

Cuba, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	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	Yes
Secondary	Presence of digestive symptoms associated with cholelithiasis		6 month	No
Secondary	Occurrence of adverse effects during treatment		6 month	Yes