Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Completed
Phase
Phase 3
Locations
Cuba
Study Type
Interventional
Intervention
Oncoxin + Viusid
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rheumatoid Arthritis focused on measuring Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
Eligibility 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
Sites / Locations
- Fructuoso Rodriguez Orthopedic Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
A
B
Arm Description
Oncoxin + Viusid
Outcomes
Primary Outcome Measures
Disease Activity Score (DAS 28 score) at week 12.
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 Outcome Measures
Number of patients with Adverse Events at week 12
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00969527
Brief Title
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
Official Title
Assessment of the Efficacy of Oncoxin+Viusid Administration in the Treatment of Rheumatoid Arthritis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2011
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
April 2011 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Catalysis SL
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
Oncoxin, Viusid, dietary supplements, rheumatoid arthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
86 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Experimental
Arm Description
Oncoxin + Viusid
Arm Title
B
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Oncoxin + Viusid
Intervention Description
50 ml of Oncoxin + Viusid (Orally administered) twice a day, for 12 weeks.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
50 ml of Placebo (orally administered) twice a day, for 12 weeks.
Primary Outcome Measure Information:
Title
Disease Activity Score (DAS 28 score) at week 12.
Description
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)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Number of patients with Adverse Events at week 12
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Juan Carlos Delgado Morales, MD
Organizational Affiliation
"Fructuoso Rodríguez" Orthopedic Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fructuoso Rodriguez Orthopedic Hospital
City
Havana
ZIP/Postal Code
10400
Country
Cuba
12. IPD Sharing Statement
Learn more about this trial
Efficacy of Oncoxin Plus Viusid in the Treatment of Rheumatoid Arthritis
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