Clinical TrialID 134

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

NCT02280876

Multiple Sclerosis, Relapsing-Remitting

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Record Fields

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Clinical Trial Id
134
Evidence Id
134
Core Evidence Id
134
Source Clinical Trial Id
129
Herb2 Clinical Trial Id
HBCT000129
Nct Id
NCT02280876
Title
Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)
Status
Completed
Phase
Phase 1|Phase 2
Study Result
No
Study Condition
Multiple Sclerosis, Relapsing-Remitting
Study Type
Interventional
Study Design
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR)|Primary Purpose: TREATMENT
Intervention
DRUG: 1 - Andrographis paniculata p/st extract|DRUG: 2 - Excipients
Intervention Allocation
Randomized
Intervention Model
Parallel
Intervention Mask
Triple
Intervention Purpose
Treatment
Gender
All
Age
Adult
Enrollment
30
Outcome Measure
Clinical inflammatory (stamina) and disability score parameters (sensorial, neurosensitive, neuromotor and cognitive function) in patients with RRMS, treated with ApE and placebo administered over beta interferon., 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., 12 months
Sponsor Collaborator
Universidad Austral de Chile|Comisión Nacional de Investigación Científica y Tecnológica|University of Chile
Funded By
OTHER
Location
Hospital Regional, Valdivia, Los Ríos, 5090000, Chile
Other Id
PaCRU-02/PCNS.EM/12|PCNS-EM
Start Date
2012-01
Primary Completion Date
2015-02
Completion Date
2015-05
First Posted
2014-11-02
Results First Posted
Last Update Posted
2016-06-23
Study Document
Study Url
https://clinicaltrials.gov/study/NCT02280876
Title Cn
Title En
Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS)
Bilingual Status
semi_complete