Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
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ClinicalTrials.gov Identifier: NCT00969527 |
Recruitment Status :
Completed
First Posted : September 1, 2009
Last Update Posted : May 9, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Rheumatoid Arthritis | Dietary Supplement: Oncoxin + Viusid Dietary Supplement: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 86 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis |
Study Start Date : | September 2009 |
Actual Primary Completion Date : | March 2011 |
Actual Study Completion Date : | April 2011 |

Arm | Intervention/treatment |
---|---|
Experimental: A
Oncoxin + Viusid
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Dietary Supplement: Oncoxin + Viusid
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks. |
Placebo Comparator: B |
Dietary Supplement: Placebo
50 ml of Placebo (orally administered) twice a day, for 12 weeks. |
- Disease Activity Score (DAS 28 score) at week 12. [ Time Frame: 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)
- Number of patients with Adverse Events at week 12 [ Time Frame: 12 weeks ]

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts 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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00969527
Cuba | |
Fructuoso Rodriguez Orthopedic Hospital | |
Havana, Cuba, 10400 |
Principal Investigator: | Juan Carlos Delgado Morales, MD | "Fructuoso Rodríguez" Orthopedic Hospital |
Responsible Party: | Juan Carlos Delgado Morales, "Fructuoso Rodríguez" Orthopedic Hospital |
ClinicalTrials.gov Identifier: | NCT00969527 |
Other Study ID Numbers: |
CAT-0903-CU |
First Posted: | September 1, 2009 Key Record Dates |
Last Update Posted: | May 9, 2011 |
Last Verified: | May 2011 |
Oncoxin Viusid dietary supplements rheumatoid arthritis |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |