Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Dietary Supplement: Oncoxin + ViusidDietary Supplement: Placebo
- Registration Number
- NCT00969527
- Lead Sponsor
- Catalysis SL
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 86
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A Oncoxin + Viusid Oncoxin + Viusid B Placebo -
- Primary Outcome Measures
Name Time Method Disease Activity Score (DAS 28 score) at week 12. 12 weeks 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)
- Secondary Outcome Measures
Name Time Method Number of patients with Adverse Events at week 12 12 weeks
Trial Locations
- Locations (1)
Fructuoso Rodriguez Orthopedic Hospital
🇨🇺Havana, Cuba