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Status unknownNCT02273635Updated Oct 27, 2014

Efficacy, Safety and Tolerability of Andrographolides Versus Placebo in Patients With Progressive Forms of MS

A Phase 1/2 interventional study of Andrographolides and placebo in Primary Progressive Multiple Sclerosis and Multiple Sclerosis, Secondary Progressive, sponsored by Innobioscience SpA. Status unknown at 1 site in Chile. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-10-27.

Sponsored by Innobioscience SpA · Phase 1/2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2014), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 1/2
Study type
Interventional
Enrollment
68
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

The purpose of this study is to compare the efficacy and safety of andrographolide 140 mg administered twice a day orally versus a placebo as a modifying treatment of the disease in patients with the progressive forms of Multiple Sclerosis (MS).

The principal outcome is to determine the efficacy, of andrographolide in retarding the progression of brain atrophy in patients with progressive forms of MS.

Read the detailed description

  1. Evaluate the clinical efficacy of andrographolide 140 mg administered orally twice a day versus a placebo in:

    • Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) and Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.
    • Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT), Symbol Digit Modalities Test (SDMT) and depression (Beck) at 24 months compared to the baseline.
    • Quality of life Multiple Sclerosis Impact Scale (MSIS 29) and fatigue (Krupp) through parameters reported by the patients at at 24 months compared to the baseline.
    • Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.
    • Delay in the decrease in brain volume measured by Magnetic Resonance (MR) at 24 months compared to the baseline.
    • Number and volume of new lesions or larger size in T2 by MR at 24 months compared to the baseline.
    • Number of new hipointense lesions in T1 or (gadolinium captive) by MR at 24 months compared to the baseline.
    • Delay in the retineal thinning measured by Optical Coherence Tomography (OCT) and visual field at 24 months compared to the baseline.
    • Safety of andrographolide at 24 months through the record of adverse effects in symptom dairy and programmed interviews.

  2. Explore the pharmacokinetic of andrographolide 140 mg administered orally twice day in:

    • bio availability and concentration of andrographolide in the patients with treatment.
    • half-life, maximum concentration, clearance of andrographolide in equilibrium state.

  3. Determine the immunomodulatory effects of andrographolide 140 mg administered twice a day orally on lymphocyte populations in patients through the:

    • Determination of Th1, Th2, Th17 and Treg lymphocyte sub-populations.
    • Determination of cytokines IFNgama, TNFalpha, IL2, IL17alpha and TGFbeta.

Population: adult patients, men and women with progressive forms of MS. The number of patients to be selected will be 68, to randomly assign 34 patients to each group.

02

Conditions studied

  • Primary Progressive Multiple Sclerosis
  • Multiple Sclerosis, Secondary Progressive
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 68 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

This is the only study on the registry with Innobioscience SpA as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Signed Informed Consent previous to the initiation of the study before any evaluation.
  • Men and women > 18 years of age with Minimental > 24.
  • Patients with diagnosis of secondary progressive MS without relapses or primary progressive MS according to the criteria of McDonald 2010.

Exclusion criteria

Exclusion Criteria:

  • Relapsing-remitting MS
  • Current Immunomodulatory or immunosuppressive therapy
  • Uncontrolled systemic diseases not controlled or treated with immunotherapy (i.e Rheumatoid Arthritis, Lupus Erythematosus).
  • Pregnant women
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
68 participants (estimated)

Study arms

  • Experimental
    andrographolides

    Coated tablets containing 140 mg andrographolides twice a day orally administered for a period of 24 months.

    Drug: Andrographolides

  • Placebo comparator
    sugar tablets

    Coated tablets containing 140 mgs excipients twice a day orally administered for a period of 24 months.

    Drug: placebo

Interventions

  • DrugAndrographolides

    140 mg andrographolides coated tablets twice a day orally administered for 24 months.

    Also known as: andrographolide, neoandrographolide, deoxyandrographolide, IB-MS 14

  • Drugplacebo

    140 mg excipients coated tablets twice a day orally administered for 24 months

06

What researchers measure

Primary outcomes

  1. Brain atrophy in patients with progressive forms of MS

    Retarding the progression of brain atrophy as measured by MR quantified by the percentage of change in volume size utilizing SIENA.

    Time frame: 24 months

Secondary outcomes

  1. Expanded Disability Status Scale (EDSS)

    Delay in the disability capacity progression through the Expanded Disability Status Scale (EDSS) at 24 months compared to the baseline.

    Time frame: 24 months

  2. Paced Auditory Serial Addition Test (PASAT)

    Delay in cognitive impairment by means of Paced Auditory Serial Addition Test (PASAT) at 24 months compared to the baseline.

    Time frame: 24 months

  3. Quality of life Multiple Sclerosis Impact Scale (MSIS 29)

    Quality of life Multiple Sclerosis Impact Scale (MSIS 29) through parameters reported by the patients at 24 months compared to the baseline.

    Time frame: 24 months

  4. Treatment Satisfaction Questionnaire for Medication (TSQM)

    Tolerability of andrographolide measured by the Treatment Satisfaction Questionnaire for Medication (TSQM) at 24 months.

    Time frame: 24 months

  5. Number of new T2 lesions

    Number of new lesions T2 by MR at 24 months compared to the baseline.

    Time frame: 24 months

  6. New hypointense lesions in T1

    Number of new hypointense lesions in T1 by MR at 24 months compared to the baseline.

    Time frame: 24 months

  7. Optical Coherence Tomography (OCT)

    Delay in the retinal thinning measured by Optical Coherence Tomography (OCT) at 24 months compared to the baseline.

    Time frame: 24 months

  8. Record of adverse effects in daily symptoms and programmed interviews.

    Safety of andrographolide at 24 months through the record of adverse effects in daily symptoms and programmed interviews.

    Time frame: 24 months

  9. Multiple Sclerosis Functional Composite (MSFC)

    Delay in the disability capacity progression through the Multiple Sclerosis Functional Composite (MSFC) at 24 months compared to the baseline.

    Time frame: 24 months

  10. Symbol Digit Modalities Test (SDMT)

    Delay in cognitive impairment by means of Symbol Digit Modalities Test (SDMT) at 24 months compared to the baseline.

    Time frame: 24 months

  11. Depression by Beck scale

    Evaluate mood disorders by means of Beck scale at 24 months compared to the baseline.

    Time frame: 24 months

  12. Fatigue by Krupp scale

    Evaluate fatigue by Krupp scale reported by the patients at 24 months compared to the baseline.

    Time frame: 24 months

  13. Number of new gadolinium enhancement lesions in T1 by MR

    Number of new gadolinium enhancement lesions in T1 by MR at 24 months compared to the baseline.

    Time frame: 24 months

  14. Visual field

    Change in visual field at 24 months compared to the baseline.

    Time frame: 24 months

  15. Volume of new T2 lesions

    Volume of size in T2 by MR at 24 months compared to the baseline.

    Time frame: 24 months

07

Study locations

1 of 1 sites recruiting
  • Multiple Sclerosis Centre, Pontificia Universidad Catolica de Chile
    Santiago, Metropolitana 8330033, Chile
    Recruiting
08

References and documents

Publications

  • Iruretagoyena MI, Tobar JA, Gonzalez PA, Sepulveda SE, Figueroa CA, Burgos RA, Hancke JL, Kalergis AM. Andrographolide interferes with T cell activation and reduces experimental autoimmune encephalomyelitis in the mouse. J Pharmacol Exp Ther. 2005 Jan;312(1):366-72. doi: 10.1124/jpet.104.072512. Epub 2004 Aug 26. PubMed 15331658 ↗
  • Iruretagoyena MI, Sepulveda SE, Lezana JP, Hermoso M, Bronfman M, Gutierrez MA, Jacobelli SH, Kalergis AM. Inhibition of nuclear factor-kappa B enhances the capacity of immature dendritic cells to induce antigen-specific tolerance in experimental autoimmune encephalomyelitis. J Pharmacol Exp Ther. 2006 Jul;318(1):59-67. doi: 10.1124/jpet.106.103259. Epub 2006 Apr 5. PubMed 16597709 ↗
  • Burgos RA, Hancke JL, Bertoglio JC, Aguirre V, Arriagada S, Calvo M, Caceres DD. Efficacy of an Andrographis paniculata composition for the relief of rheumatoid arthritis symptoms: a prospective randomized placebo-controlled trial. Clin Rheumatol. 2009 Aug;28(8):931-46. doi: 10.1007/s10067-009-1180-5. Epub 2009 Apr 29. PubMed 19408036 ↗
  • Cabrera D, Gutierrez J, Cabello-Verrugio C, Morales MG, Mezzano S, Fadic R, Casar JC, Hancke JL, Brandan E. Andrographolide attenuates skeletal muscle dystrophy in mdx mice and increases efficiency of cell therapy by reducing fibrosis. Skelet Muscle. 2014 Mar 21;4:6. doi: 10.1186/2044-5040-4-6. eCollection 2014. PubMed 24655808 ↗
  • Carretta MD, Alarcon P, Jara E, Solis L, Hancke JL, Concha II, Hidalgo MA, Burgos RA. Andrographolide reduces IL-2 production in T-cells by interfering with NFAT and MAPK activation. Eur J Pharmacol. 2009 Jan 14;602(2-3):413-21. doi: 10.1016/j.ejphar.2008.11.011. Epub 2008 Nov 13. PubMed 19038244 ↗
  • Burgos RA, Seguel K, Perez M, Meneses A, Ortega M, Guarda MI, Loaiza A, Hancke JL. Andrographolide inhibits IFN-gamma and IL-2 cytokine production and protects against cell apoptosis. Planta Med. 2005 May;71(5):429-34. doi: 10.1055/s-2005-864138. PubMed 15931581 ↗
  • Hidalgo MA, Romero A, Figueroa J, Cortes P, Concha II, Hancke JL, Burgos RA. Andrographolide interferes with binding of nuclear factor-kappaB to DNA in HL-60-derived neutrophilic cells. Br J Pharmacol. 2005 Mar;144(5):680-6. doi: 10.1038/sj.bjp.0706105. PubMed 15678086 ↗
  • Sandborn WJ, Targan SR, Byers VS, Rutty DA, Mu H, Zhang X, Tang T. Andrographis paniculata extract (HMPL-004) for active ulcerative colitis. Am J Gastroenterol. 2013 Jan;108(1):90-8. doi: 10.1038/ajg.2012.340. Epub 2012 Oct 9. PubMed 23044768 ↗
  • Tang T, Targan SR, Li ZS, Xu C, Byers VS, Sandborn WJ. Randomised clinical trial: herbal extract HMPL-004 in active ulcerative colitis - a double-blind comparison with sustained release mesalazine. Aliment Pharmacol Ther. 2011 Jan;33(2):194-202. doi: 10.1111/j.1365-2036.2010.04515.x. Epub 2010 Nov 30. PubMed 21114791 ↗
  • Ciampi E, Uribe-San-Martin R, Carcamo C, Cruz JP, Reyes A, Reyes D, Pinto C, Vasquez M, Burgos RA, Hancke J. Efficacy of andrographolide in not active progressive multiple sclerosis: a prospective exploratory double-blind, parallel-group, randomized, placebo-controlled trial. BMC Neurol. 2020 May 7;20(1):173. doi: 10.1186/s12883-020-01745-w. PubMed 32380977 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02273635
Lead sponsor
Innobioscience SpA
Collaborators
Pontificia Universidad Catolica de Chile, University of Chile, Universidad Austral de Chile
Responsible party
Sponsor
First posted
Oct 24, 2014
Start date
Sep 2014
Primary completion
Nov 2016 (estimated)
Completion
Apr 2017 (estimated)
Last update
Oct 27, 2014

Study contacts

Claudia A Carcamo, MD, PhD
Contact
ccarcamo@med.puc.cl
+56223546885
Ethel L Ciampi, MD
Contact
anticsnap@gmail.com
+56223546885
Juan L Hancke, DVM, PhD
study director · Universidad Austral de Chile

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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