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Trial record 23 of 761 for:    region | Chile

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

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ClinicalTrials.gov Identifier: NCT02280876
Recruitment Status : Completed
First Posted : November 3, 2014
Last Update Posted : June 23, 2016
Sponsor:
Collaborators:
Comisión Nacional de Investigación Científica y Tecnológica
University of Chile
Information provided by (Responsible Party):
Juan C. Bertoglio, MD, Universidad Austral de Chile

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 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

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.

Other Names:

• ApE tablets, EUROMED Specific. Santiago Chile.

Other Names:
  • Andrographolide
  • Verum formulation
  • Andrographis paniculata Extract ( ApE )
  • Paractin®

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.

Other Names:

• Excipients tablets EUROMED Specific. Santiago Chile

Other Name: Placebo formulation




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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.

  2. 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



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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280876


Locations
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Chile
Hospital Regional
Valdivia, Los Ríos, Chile, 5090000
Sponsors and Collaborators
Universidad Austral de Chile
Comisión Nacional de Investigación Científica y Tecnológica
University of Chile
Investigators
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Study Director: Juan L. Hancke, PhD Universidad Austral de Chile

Additional Information:
Publications of Results:
Other Publications:

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Responsible Party: Juan C. Bertoglio, MD, Principal Clinical Investigator, Universidad Austral de Chile
ClinicalTrials.gov Identifier: NCT02280876     History of Changes
Other Study ID Numbers: PaCRU-02/PCNS.EM/12
PCNS-EM ( Other Grant/Funding Number: FONDEF D09I1085 (CONICYT - Chile) )
First Posted: November 3, 2014    Key Record Dates
Last Update Posted: June 23, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: All these trial results, will be submitted to publication in a major journal of the specialty, upon conclusion of data processing and evaluation.

Keywords provided by Juan C. Bertoglio, MD, Universidad Austral de Chile:
MS
Demyelinating Autoimmune Diseases
CNS
Nervous System Diseases

Additional relevant MeSH terms:
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Sclerosis
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Andrographolide
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antirheumatic Agents
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antiviral Agents
Platelet Aggregation Inhibitors