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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidad Austral de Chile
• Collaborators: Comisión Nacional de Investigación Científica y Tecnológica; University of Chile
• Treatments: Andrographolide

Criteria

Inclusion Criteria:

• Patients diagnosed with MS according to McDonald scale

• Relapsing Remitting Forms of MS (subtypes of Lublin)

• Minor or less incapacity according to EDSS scale

• At least one relapse in the last 2 years

• Sign an informed consent

Exclusion Criteria:

• Primary and Secondary Progressive MS patients.

• Use of corticosteroids up to one month previous to enrollment

• Use of immunosuppressors up to one month previous to enrollment

• Use of drugs that induce hepatic metabolism

• Pregnancy, contraception, breast feeding.

• Psychiatric disorders

• Systemic diseases

• Chronic renal failure

• Diabetes mellitus

• Cardiac failure

• Respiratory failure

• Cancer