A Phase 3 interventional study of Renalof and Placebo in Cholelithiasis, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 65 Years and older. Per ClinicalTrials.gov, last updated 2012-05-08.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
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.
199 studies on the registry are indexed under Gallstones; 35 are open to participants now.
This study's enrollment of 40 is below the median of 98 across 121 interventional studies indexed under Gallstones.
Browse Gallstones studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
Compared within Gallstones, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cholelithiasis. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dietary Supplement: Renalof
Dietary Supplement: Placebo
One 325 mg Renalof tablet (Orally administered) every 8 hours, for 6 months.
One Placebo tablet (Orally administered) every 8 hours, for 6 months
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
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
Presence of digestive symptoms associated with cholelithiasis
Time frame: 6 month
Occurrence of adverse effects during treatment
Time frame: 6 month
The record gives a start of Jan 2010, a primary completion of Jun 2011 and a completion of Jun 2011. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2012. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.