A Phase 3 interventional study of Oncoxin + Viusid and Placebo in Rheumatoid Arthritis, sponsored by Catalysis SL. Completed at 1 site in Cuba. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2011-05-09.
Sponsored by Catalysis SL · Phase 3, Interventional, and Treatment
The purpose of the study is to assess the efficacy of Oncoxin+Viusid administration in the treatment of rheumatoid arthritis. The duration of this double-blind placebo controlled phase 3 clinical trial will be 12 weeks. The estimated number of persons with rheumatoid arthritis to be recruited and randomized for the study is 86. The primary outcome measure: DAS28 score will be assessed at the end of the study.
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 86 is below the median of 96 across 2,220 interventional studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Catalysis SL is the lead sponsor of 53 studies on the registry; 4 are open to participants now.
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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.
Oncoxin + Viusid
Dietary Supplement: Oncoxin + Viusid
Dietary Supplement: Placebo
Drug pages: Green Tea Extract-based Antioxidant Supplement · Viusid
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
50 ml of Placebo (orally administered) twice a day, for 12 weeks.
Disease Activity Score (DAS 28 score) at week 12.
DAS 28=(0.56√NAD+ 0.28√NAT+0.7lnVSG+0.14EGE) where NAD: number of joints with pain; NAT: number of joints with increased volume; VSG: sedimentation rate of erythrocytes; EGE: Global assessment of disease by the patient on a visual analog scale (1 to 100 mm)
Time frame: 12 weeks
Number of patients with Adverse Events at week 12
Time frame: 12 weeks
The record gives a start of Sep 2009, a primary completion of Mar 2011 and a completion of Apr 2011. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Green Tea Extract-based Antioxidant Supplement · Viusid