Renalof in the Treatment of Elderly Patients With Gallstones

Catalysis SL

Status and phase: Completed; Phase 3

Conditions: Cholelithiasis

Treatments: Dietary Supplement: Renalof; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01099319

CAT-1001-CU

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 65+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

40 participants in 2 patient groups, including a placebo group

Renalof

Experimental group

Treatment:

Dietary Supplement: Renalof

Placebo

Placebo Comparator group

Treatment:

Dietary Supplement: Placebo