Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)
Status:
Completed
Trial end date:
2015-05-01
Target enrollment:
Participant gender:
Summary
To evaluate the efficacy of ApE coated tablets, on the relapse rate in a group of relapsing
remitting multiple sclerosis (RRMS) patients, as compared to a placebo group in a period of
12 months. This study will also determine the safety and tolerability of the drug
administered over interferon beta vs. administration of a placebo formulation (also over
interferon) during the evaluation period. Response will be assessed and measured by daily
self patient recording, monthly clinical neurologist, and every three months serological and
magnetic resonance parameters.
Place of Study: National study in Chile with one center at the Regional Hospital in the city
of Valdivia, including 30 patients enrolled by their respective neurologists.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
Universidad Austral de Chile
Collaborators:
Comisión Nacional de Investigación Científica y Tecnológica University of Chile