CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
FANG(30) +1 moredrug
Likely dose
FANG(30) 30mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00749645
NCT00749645Phase 2Completed
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Clinical Phase II Pilot Study of the Efficacy of FANG(30) to Treat Active Rheumatoid Arthritis in Adult Patients

Juan C. Bertoglio, MD·interventional·Posted Sep 9, 2008·Updated Jun 23, 2016

In Brief

A Phase 2 clinical trial evaluating FANG(30) and Placebo for Arthritis, Rheumatoid. Completed, enrolled 60 participants across 2 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsArthritis, Rheumatoid
CountriesChile
CollaboratorsFondo Nacional de Desarrollo Científico y Tecnológico, Chile

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 9, 2008
Enrollment StartOct 1, 2006
Primary CompletionJan 1, 2008
Study CompletionFeb 1, 2008
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 17.8 years ago

Interventions

FANG(30)drug

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

Placebodrug

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