Rheumatoid Arthritis
Conditions
Keywords
Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
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.
Interventions
DIETARY_SUPPLEMENTOncoxin + Viusid
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
DIETARY_SUPPLEMENTPlacebo
50 ml of Placebo (orally administered) twice a day, for 12 weeks.
Sponsors
Catalysis SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Number of patients with Adverse Events at week 12 | 12 weeks |
Countries
Cuba
Outcome results
None listed