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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014