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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
History of Changes
  Purpose

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 Intervention Phase
Rheumatoid Arthritis
 Dietary Supplement: Oncoxin + Viusid
Dietary Supplement: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Catalysis SL:

Primary Outcome Measures:
  • 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)


Secondary Outcome Measures:
  • Number of patients with Adverse Events at week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 86
Study Start Date: September 2009
Study Completion Date: April 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00969527

Locations
Cuba
Fructuoso Rodriguez Orthopedic Hospital
Havana, Cuba, 10400
Sponsors and Collaborators
Catalysis SL
Investigators
Principal Investigator: Juan Carlos Delgado Morales, MD "Fructuoso Rodríguez" Orthopedic Hospital
  More Information

No publications provided

Responsible Party: Juan Carlos Delgado Morales, "Fructuoso Rodríguez" Orthopedic Hospital
ClinicalTrials.gov Identifier: NCT00969527     History of Changes
Other Study ID Numbers: CAT-0903-CU
Study First Received: August 27, 2009
Last Updated: May 6, 2011
Health Authority: Cuba: National Coordinating Center of Clinical Trials (CENCEC)

Keywords provided by Catalysis SL:
Oncoxin
Viusid
dietary supplements
rheumatoid arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 19, 2013