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Efficacy Study of FANG(30) for Active Rheumatoid Arthritis in Adult Patients

NCT00749645 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2016-06-23

No results posted yet for this study

Summary

This is a Clinical Pilot Phase II interventional, double blind, randomized and placebo controlled study to document the efficacy, tolerability and safety of FANG(30) in 60 adult patients affected with active Rheumatoid Arthritis. Also, to evaluate the effect of an andrographolide natural formula, identified as FANG(30) or "the study product", on the immunological functions that influence chronic inflammatory process in these patients, who could benefit with this treatment.

Conditions

  • Arthritis, Rheumatoid

Interventions

DRUG

FANG(30)

Andrographolide formula Oral tablets, 30mg, three times per day, during a total of 105 continuous days.

DRUG

Placebo

Placebo 30mg tabs, 3/day, 105 days continuously.

Sponsors & Collaborators

  • Fondo Nacional de Desarrollo Científico y Tecnológico, Chile

    collaborator OTHER_GOV

  • Juan C. Bertoglio, MD

    lead OTHER

Principal Investigators

  • Juan L. Hancke, DVM, PhD · Universidad Austral de Chile

  • Rafael A. Burgos, DVM, MSc · Universidad Austral de Chile

  • Juan C. Bertoglio, MD · Universidad Austral de Chile

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-10-31
Primary Completion
2008-01-31
Completion
2008-02-29

Countries

  • Chile

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00749645 on ClinicalTrials.gov