Efficacy Study of Andrographis Paniculata Purified Standardized Extrac
Randomized, Comparative, Double Blind Controlled Phase II Clinical Trial, to Evaluate the Efficacy of ApE in Patients With Multiple Sclerosis (MS).
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Andrographolide
Placebo
- 2 - Excipients
What it measured
Main measures
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.
12 months
Disability progressionThinking and memoryFatigueImmune response
Other 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)
12 months
Immune responseSafety
Who could take part
Relapsing MS · 18 to 55
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
Andrographis paniculata decreases fatigue in patients with relapsing-remitting multiple sclerosis: a 12-month double-blind placebo-controlled pilot study.BMC Neurol · 2016
Background
Noseworthy JH, Lucchinetti C, Rodriguez M, Weinshenker BG. Multiple sclerosis. N Engl J Med. 2000 Sep 28;343(13):938-52. doi: 10.1056/NEJM200009283431307. No abstract available.Background
Wingerchuk DM, Lucchinetti CF, Noseworthy JH. Multiple sclerosis: current pathophysiological concepts. Lab Invest. 2001 Mar;81(3):263-81. doi: 10.1038/labinvest.3780235.Background
Galboiz Y, Miller A. Immunological indicators of disease activity and prognosis in multiple sclerosis. Curr Opin Neurol. 2002 Jun;15(3):233-7. doi: 10.1097/00019052-200206000-00002.Background
Phillips JT, Rice G, Frohman E, Vande Gaer L, Scott T, Haas J, Eggenberger E, Freedman MS, Stuart W, Cunha L, Jacobs L, Oger J, Arnold D, Murray TJ, DiBiase M, Jethwa V, Goelz S. A multicenter, open-label, phase II study of the immunogenicity and safety of a new prefilled syringe (liquid) formulation of Avonex in patients with multiple sclerosis. Clin Ther. 2004 Apr;26(4):511-21. doi: 10.1016/s014Background
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.Background
Rajagopal S, Kumar RA, Deevi DS, Satyanarayana C, Rajagopalan R. Andrographolide, a potential cancer therapeutic agent isolated from Andrographis paniculata. J Exp Ther Oncol. 2003 May-Jun;3(3):147-58. doi: 10.1046/j.1359-4117.2003.01090.x.Background
Calabrese C, Berman SH, Babish JG, Ma X, Shinto L, Dorr M, Wells K, Wenner CA, Standish LJ. A phase I trial of andrographolide in HIV positive patients and normal volunteers. Phytother Res. 2000 Aug;14(5):333-8. doi: 10.1002/1099-1573(200008)14:53.0.co;2-d.Background
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.Background
Burgos RA, Hidalgo MA, Monsalve J, LaBranche TP, Eyre P, Hancke JL. 14-deoxyandrographolide as a platelet activating factor antagonist in bovine neutrophils. Planta Med. 2005 Jul;71(7):604-8. doi: 10.1055/s-2005-871264.
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History
Started
Jan 2012
Main results due
Feb 2015
Finished
May 2015