1 - Andrographis paniculata extract. Active comparator, consists of 15 adult patients with active Recurrent Remitting Multiple Sclerosis, randomly assigned, taking the active test product (Andrographis paniculata p/st extract, oral lozenges, one BID, for 12 months), in addition to base medication (Interferon).

2 - Excipients. Placebo comparator, consists of 15 adult patients with active Recurrent Remitting Multiple Sclerosis, randomly assigned, taking the placebo formulation (Only the excipients of the active test product, in oral lozenges of same shape, one BID, for 12 months), in addition to base medication (Interferon).

Multiple Sclerosis, Relapsing-Remitting

Andrographis paniculata Extract (ApE), Oral tablets 650 mg, with 170 mg. of andrographolides active principles, three times per day, during a total of 365 continuous days.
Other Names:
• ApE tablets, EUROMED Specific. Santiago Chile.

1 - Andrographis paniculata p/st extract

Placebo 650mg tabs, 2/day, 365 days continuously.
Other Names:
• Excipients tablets EUROMED Specific. Santiago Chile

2 - Excipients

Miller, Aaron E.; Coyle, Patricia K. CLINICAL FEATURES OF MULTIPLE SCLEROSIS. CONTINUUM: Lifelong Learning in Neurology. December 2004 - Volume 10 - Issue 6, Multiple Sclerosis - pp 38-73. doi: 10.1212/01.CON.0000293634.15851.7d

María A. Hidalgo, Juan L. Hancke, Juan C. Bertoglio and Rafael A. Burgos. Andrographolide, a New Potential Drug for the Long Term Treatment of Rheumatoid Arthritis Disease. Innovative Rheumatology. International standard book (ISBN) 978-953-51-0916-7

Hospital Regional

Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)

Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).

Clinical parameters (stamina, sensorial, neurosensitive, neuromotor and cognitive function), will be measured by the Fatigue Severity Scale (FSS) and Expanded Disability Scale (EDSS) in patients with RRMS treated with ApE and placebo.

Patients dairy of possible adverse symptoms, general clinical laboratory and comparative statistical parameters

CNS number, size, location and gadolinium uptaking of lesions in brain and / or spine will be measured by magnetic resonance (MR) at 0, 3, 6 and 12 months.

Plasmatic levels of IFNg, Interleukin 17 (IL17), Interleukin IL10, Interleukin 6 (IL6), IL4, TNFa, will be measured at 0, 3, 6 and 12 months

All these trial results, will be submitted to publication in a major journal of the specialty, upon conclusion of data processing and evaluation.

Juan C. Bertoglio, MD

Principal Clinical Investigator

Universidad Austral de Chile

Comisión Nacional de Investigación Científica y Tecnológica

University of Chile

1 - Active comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the active product, in addition to base medication (Mtx + Pdn)

2 - Placebo comparator, consisted of 30 adult patients with active Rheumatoid Arthritis, randomly assigned, taking the placebo formulation, in addition to base medication (Mtx + Pdn)

Arthritis, Rheumatoid

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

FANG(30)

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

Placebo

Government of Chile - Science and Technology Development Fund (Study main sponsor)

deoxyandrographolide/andrographis

Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)

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

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