Biomaterial Database

The effect of Neuragen PN on neuropathic pain: A randomized, double blind, placebo controlled clinical trial. 2010

Li Li

Department of Kinesiology, Louisiana State University, Baton Rouge, 70803, USA. lli3@lsu.edu

BACKGROUND A double blind, randomized, placebo controlled study to evaluate the safety and efficacy of the naturally derived topical oil, "Neuragen PN" for the treatment of neuropathic pain. METHODS Sixty participants with plantar cutaneous (foot sole) pain due to all cause peripheral neuropathy were recruited from the community. Each subject was randomly assigned to receive one of two treatments (Neuragen PN or placebo) per week in a crossover design. The primary outcome measure was acute spontaneous pain level as reported on a visual analog scale. RESULTS There was an overall pain reduction for both treatments from pre to post application. As compared to the placebo, Neuragen PN led to significantly (p < .05) greater pain reduction. Fifty six of sixty subjects (93.3%) receiving Neuragen PN reported pain reduction within 30 minutes. This reduction within 30 minutes occurred in only twenty one of sixty (35.0%) subjects receiving the placebo. In a break out analysis of the diabetic only subgroup, 94% of subjects in the Neuragen PN group achieved pain reduction within 30 minutes vs 11.0% of the placebo group. No adverse events were observed. CONCLUSIONS This randomized, placebo controlled, clinical trial with crossover design revealed that the naturally derived oil, Neuragen PN, provided significant relief from neuropathic pain in an all cause neuropathy group. Participants with diabetes within this group experienced similar pain relief. BACKGROUND ISRCTN registered: ISRCTN13226601.

UI	MeSH Term	Description	Entries
D008297	Male		Males
D008419	Materia Medica	Materials or substances used in the composition of traditional medical remedies. The use of this term in MeSH was formerly restricted to historical articles or those concerned with traditional medicine, but it can also refer to homeopathic remedies. Nosodes are specific types of homeopathic remedies prepared from causal agents or disease products.	Homeopathic Remedies,Nosodes,Medica, Materia,Remedies, Homeopathic
D008875	Middle Aged	An adult aged 45 - 64 years.	Middle Age
D009437	Neuralgia	Intense or aching pain that occurs along the course or distribution of a peripheral or cranial nerve.	Nerve Pain,Neurodynia,Paroxysmal Nerve Pain,Neuralgia, Atypical,Neuralgia, Iliohypogastric Nerve,Neuralgia, Ilioinguinal,Neuralgia, Perineal,Neuralgia, Stump,Neuralgia, Supraorbital,Neuralgia, Vidian,Neuropathic Pain,Atypical Neuralgia,Atypical Neuralgias,Iliohypogastric Nerve Neuralgia,Iliohypogastric Nerve Neuralgias,Ilioinguinal Neuralgia,Ilioinguinal Neuralgias,Nerve Neuralgia, Iliohypogastric,Nerve Neuralgias, Iliohypogastric,Nerve Pain, Paroxysmal,Nerve Pains,Nerve Pains, Paroxysmal,Neuralgias,Neuralgias, Atypical,Neuralgias, Iliohypogastric Nerve,Neuralgias, Ilioinguinal,Neuralgias, Perineal,Neuralgias, Stump,Neuralgias, Supraorbital,Neuralgias, Vidian,Neurodynias,Neuropathic Pains,Pain, Nerve,Pain, Neuropathic,Pain, Paroxysmal Nerve,Pains, Nerve,Pains, Neuropathic,Pains, Paroxysmal Nerve,Paroxysmal Nerve Pains,Perineal Neuralgia,Perineal Neuralgias,Stump Neuralgia,Stump Neuralgias,Supraorbital Neuralgia,Supraorbital Neuralgias,Vidian Neuralgia,Vidian Neuralgias
D009822	Oils, Volatile	Oils which evaporate readily. The volatile oils occur in aromatic plants, to which they give odor and other characteristics. Most volatile oils consist of a mixture of two or more TERPENES or of a mixture of an eleoptene (the more volatile constituent of a volatile oil) with a stearopten (the more solid constituent). The synonym essential oils refers to the essence of a plant, as its perfume or scent, and not to its indispensability.	Essential Oil,Oil, Essential,Oil, Volatile,Oils, Essential,Volatile Oil,Essential Oils,Volatile Oils
D010523	Peripheral Nervous System Diseases	Diseases of the peripheral nerves external to the brain and spinal cord, which includes diseases of the nerve roots, ganglia, plexi, autonomic nerves, sensory nerves, and motor nerves.	Peripheral Nerve Diseases,Peripheral Neuropathies,PNS (Peripheral Nervous System) Diseases,PNS Diseases,Peripheral Nervous System Disease,Peripheral Nervous System Disorders,Nerve Disease, Peripheral,Nerve Diseases, Peripheral,Neuropathy, Peripheral,PNS Disease,Peripheral Nerve Disease,Peripheral Neuropathy
D010758	Phosphorus	A non-metal element that has the atomic symbol P, atomic number 15, and atomic weight 31. It is an essential element that takes part in a broad variety of biochemical reactions.	Black Phosphorus,Phosphorus-31,Red Phosphorus,White Phosphorus,Yellow Phosphorus,Phosphorus 31,Phosphorus, Black,Phosphorus, Red,Phosphorus, White,Phosphorus, Yellow
D010936	Plant Extracts	Concentrated pharmaceutical preparations of plants obtained by removing active constituents with a suitable solvent, which is evaporated away, and adjusting the residue to a prescribed standard.	Herbal Medicines,Plant Extract,Extract, Plant,Extracts, Plant,Medicines, Herbal
D003929	Diabetic Neuropathies	Peripheral, autonomic, and cranial nerve disorders that are associated with DIABETES MELLITUS. These conditions usually result from diabetic microvascular injury involving small blood vessels that supply nerves (VASA NERVORUM). Relatively common conditions which may be associated with diabetic neuropathy include third nerve palsy (see OCULOMOTOR NERVE DISEASES); MONONEUROPATHY; mononeuropathy multiplex; diabetic amyotrophy; a painful POLYNEUROPATHY; autonomic neuropathy; and thoracoabdominal neuropathy. (From Adams et al., Principles of Neurology, 6th ed, p1325)	Diabetic Amyotrophy,Diabetic Autonomic Neuropathy,Diabetic Neuralgia,Diabetic Polyneuropathy,Neuralgia, Diabetic,Asymmetric Diabetic Proximal Motor Neuropathy,Diabetic Asymmetric Polyneuropathy,Diabetic Mononeuropathy,Diabetic Mononeuropathy Simplex,Diabetic Neuropathy, Painful,Mononeuropathy, Diabetic,Symmetric Diabetic Proximal Motor Neuropathy,Amyotrophies, Diabetic,Amyotrophy, Diabetic,Asymmetric Polyneuropathies, Diabetic,Asymmetric Polyneuropathy, Diabetic,Autonomic Neuropathies, Diabetic,Autonomic Neuropathy, Diabetic,Diabetic Amyotrophies,Diabetic Asymmetric Polyneuropathies,Diabetic Autonomic Neuropathies,Diabetic Mononeuropathies,Diabetic Mononeuropathy Simplices,Diabetic Neuralgias,Diabetic Neuropathies, Painful,Diabetic Neuropathy,Diabetic Polyneuropathies,Mononeuropathies, Diabetic,Mononeuropathy Simplex, Diabetic,Mononeuropathy Simplices, Diabetic,Neuralgias, Diabetic,Neuropathies, Diabetic,Neuropathies, Diabetic Autonomic,Neuropathies, Painful Diabetic,Neuropathy, Diabetic,Neuropathy, Diabetic Autonomic,Neuropathy, Painful Diabetic,Painful Diabetic Neuropathies,Painful Diabetic Neuropathy,Polyneuropathies, Diabetic,Polyneuropathies, Diabetic Asymmetric,Polyneuropathy, Diabetic,Polyneuropathy, Diabetic Asymmetric,Simplex, Diabetic Mononeuropathy,Simplices, Diabetic Mononeuropathy
D004311	Double-Blind Method	A method of studying a drug or procedure in which both the subjects and investigators are kept unaware of who is actually getting which specific treatment.	Double-Masked Study,Double-Blind Study,Double-Masked Method,Double Blind Method,Double Blind Study,Double Masked Method,Double Masked Study,Double-Blind Methods,Double-Blind Studies,Double-Masked Methods,Double-Masked Studies,Method, Double-Blind,Method, Double-Masked,Methods, Double-Blind,Methods, Double-Masked,Studies, Double-Blind,Studies, Double-Masked,Study, Double-Blind,Study, Double-Masked