Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by:
Catalysis SL
ClinicalTrials.gov Identifier:
NCT00969527
First received: August 27, 2009
Last updated: May 6, 2011
Last verified: May 2011

August 27, 2009
May 6, 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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00969527 on ClinicalTrials.gov Archive Site
Number of patients with Adverse Events at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Adverse effects at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Cuba
 
NCT00969527
CAT-0903-CU
Yes
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