Efficacy Study of Andrographis Paniculata Purified Standardized Extract (ApE) in Patients With Multiple Sclerosis (MS) (PCNS-EM)
|ClinicalTrials.gov Identifier: NCT02280876|
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : June 23, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis, Relapsing-Remitting||Drug: 1 - Andrographis paniculata p/st extract Drug: 2 - Excipients||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||February 2015|
|Actual Study Completion Date :||May 2015|
Active Comparator: 1 - Andrographis paniculata p/st extract
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).
Drug: 1 - Andrographis paniculata p/st extract
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.
• ApE tablets, EUROMED Specific. Santiago Chile.
Placebo Comparator: 2 - Excipients
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).
Drug: 2 - Excipients
Placebo 650mg tabs, 2/day, 365 days continuously.
• Excipients tablets EUROMED Specific. Santiago Chile
Other Name: Placebo formulation
- 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. [ Time Frame: 12 months ]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.
- Safety, tolerability and efficacy of ApE and placebo administered over beta interferon in RRMS treated patients (adverse symptoms, general clinical laboratory and comparative statistical parameters) [ Time Frame: 12 months ]Patients dairy of possible adverse symptoms, general clinical laboratory and comparative statistical parameters
- Central Nervous System (CNS) local inflammatory activity and anatomical damage parameters (functional and structural lesions) in RRMS patients treated with ApE and placebo administered over beta interferon. [ Time Frame: 12 months ]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 inflammatory activity parameters (cytokines) in RRMS patients treated with ApE and placebo administered over beta interferon. [ Time Frame: 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280876
|Valdivia, Los Ríos, Chile, 5090000|
|Study Director:||Juan L. Hancke, PhD||Universidad Austral de Chile|