Renalof in the Treatment of Elderly Patients With Gallstones

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01099319

Enrollment

Registered

2010-04-06

Start date

2010-01-31

Completion date

2011-06-30

Last updated

2012-05-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholelithiasis

Keywords

Dietary supplement, Renalof, gallstones, elderly

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.

Interventions

DIETARY_SUPPLEMENTRenalof

One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.

DIETARY_SUPPLEMENTPlacebo

One Placebo tablet (Orally administered) every 8 hours, for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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)	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)	6 month

Secondary

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

Countries

Cuba

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026