Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00969527
Recruitment Status : Completed
First Posted : September 1, 2009
Last Update Posted : May 9, 2011
Information provided by:
Catalysis SL

August 27, 2009
September 1, 2009
May 9, 2011
September 2009
March 2011   (Final data collection date for primary outcome measure)
Disease Activity Score (DAS 28 score) at week 12. [ Time Frame: 12 weeks ]
DAS 28=(0.56√NAD+ 0.28√NAT+0.7ln⁡VSG+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)
DAS 28 score at week 12. [ Time Frame: 12 weeks ]
Complete list of historical versions of study NCT00969527 on Archive Site
Number of patients with Adverse Events at week 12 [ Time Frame: 12 weeks ]
Adverse effects at week 12 [ Time Frame: 12 weeks ]
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Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
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.
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Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Rheumatoid Arthritis
  • Dietary Supplement: Oncoxin + Viusid
    50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
  • Dietary Supplement: Placebo
    50 ml of Placebo (orally administered) twice a day, for 12 weeks.
  • Experimental: A
    Oncoxin + Viusid
    Intervention: Dietary Supplement: Oncoxin + Viusid
  • Placebo Comparator: B
    Intervention: Dietary Supplement: Placebo
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
April 2011
March 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Treatment-naive subjects with recent onset rheumatoid arthritis
  • Signed informed consent

Exclusion Criteria:

  • Subjects with rheumatoid arthritis symptoms other than those associated with joints at disease onset
  • Subjects with joint function impairment secondary to other conditions not associated with rheumatoid arthritis
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Juan Carlos Delgado Morales, "Fructuoso Rodríguez" Orthopedic Hospital
Catalysis SL
Not Provided
Principal Investigator: Juan Carlos Delgado Morales, MD "Fructuoso Rodríguez" Orthopedic Hospital
Catalysis SL
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP