CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 30 enrolled
Drug / intervention
1 - Andrographis paniculata p/st extract +1 moredrug
Likely dose
1 - Andrographis paniculata p/st extract 650 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02280876
NCT02280876Phase 2Completed
CompareCT.gov

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

Universidad Austral de Chile·interventional·Posted Nov 3, 2014·Updated Jun 23, 2016

In Brief

A Phase 2 clinical trial evaluating 1 - Andrographis paniculata p/st extract and 2 - Excipients for Multiple Sclerosis, Relapsing-Remitting. Completed, enrolled 30 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsMultiple Sclerosis, Relapsing-Remitting
CountriesChile
CollaboratorsComisión Nacional de Investigación Científica y Tecnológica, University of Chile

Timeline

Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedNov 3, 2014
Enrollment StartJan 1, 2012
Primary CompletionFeb 1, 2015
Study CompletionMay 1, 2015
TodayJul 2, 2026
Enrollment to primary: 3.1 yearsPosted 11.7 years ago

Interventions

1 - Andrographis paniculata p/st extractdrug

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.

2 - Excipientsdrug

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