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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
Sponsor:
Information provided by:
Catalysis SL

Study Description
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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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Dietary Supplement: Oncoxin + Viusid Dietary Supplement: Placebo Phase 3

Study Design
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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

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Arms and Interventions
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Arm Intervention/treatment
Experimental: A
Oncoxin + Viusid
 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.


Outcome Measures
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Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. Number of patients with Adverse Events at week 12 [ Time Frame: 12 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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


Locations
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Cuba
Fructuoso Rodriguez Orthopedic Hospital
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
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Principal Investigator: Juan Carlos Delgado Morales, MD "Fructuoso Rodríguez" Orthopedic Hospital
More Information
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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
Keywords provided by Catalysis SL:
Oncoxin
Viusid
dietary supplements
rheumatoid arthritis
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases