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NCT Number: NCT01099319

Renalof in the Treatment of Elderly Patients With Gallstones

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.

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Key information

Conditions

Cholelithiasis Biliary Tract Diseases Calculi Cholecystolithiasis Digestive System Diseases Gallbladder Diseases Gallstones Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

"Dr. Salvador Allende" Clinical-Surgical-Docent Hospital

Havana, La Habana, Cuba

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Renalof

Dietary Supplement

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

Placebo

Dietary Supplement

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

Primary outcomes

  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 outcomes

  1. Presence of digestive symptoms associated with cholelithiasis

    Time frame: 6 month

  2. Occurrence of adverse effects during treatment

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Catalysis SL

Industry

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Apr 6, 2010
Registry last updated
May 8, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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