Status:
COMPLETED
Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)
Lead Sponsor:
Universidad Austral de Chile
Collaborating Sponsors:
Comisión Nacional de Investigación Científica y Tecnológica
University of Chile
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
Introduction: Multiple sclerosis is a chronic inflammatory demyelinating disease of the central nervous system that predominantly affects young adults (1). Although its etiology has not yet been eluci...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2015
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02280876
Start Date
January 1 2012
End Date
May 1 2015
Last Update
June 23 2016
Active Locations (1)
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1
Hospital Regional
Valdivia, Los Ríos Region, Chile, 5090000