FORM-2
THE PATENTS ACT, 1970
(39 of 1970)
&
THE PATENTS RULES, 2003
PROVISIONAL
Specification
(See section 10 and rule 13)
HOMEOPATHIC COMBINATION TREATMENT TO HEAL NEUROLOGICAL DISORDERS
(a) OSWAL GUNVANT DEVICHAND,
an Indian National, of 12, Akash Darshan Society, Survey No. 585, Gultekdi,
Pune 411 037 Maharashtra, India; and
(b) OSWAL POOJA GUNVANT,
an Indian National,
of Bldg. No. 18, Clover Highland, Near NIBM, Kondhwa, Pune 411 048,
Maharashtra, India
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION.

Field of the Invention:
This invention relates to a formulation for the treatment of neurological disorders and conditions including, but not restricted to, Cerebral Palsy, Mental Subnormality, Autism, Down's Syndrome, Global Delays, Developmental Disabilities, Neuropathies, Brain Injuries, various Neurological Syndromes, Neurometabolic Disorders, Stroke, and the like. The invented formulation envisaged is a combination of homeopathic remedies, which leads to positive improvements in patients suffering from neurological disorders.
Background & Prior art:
Neurological disorders including mental subnormality affect between 1-3% of the total worldwide population according to World Health Organization (WHO) estimates. Rehabilitation of patients with these disorders mainly depends upon measures like assistive technology; speech therapy; behavioral therapy; occupational therapy; counseling; symptomatic drug therapy for convulsions, involuntary movements, spasticity, etc; and surgery for corrective measures. But currently there is very little choice of treatment to heal these disorders and they are generally considered irreversible. The development of an effective medical and drug-based treatment of these disorders is thus a challenge before the medical field.
The present invention discloses a combination of homoeopathic medicines for the treatment of the aforesaid neurological disorders.
The history of homeopathy goes back to the eighteenth century and the research of the German physician Samuel Hahnemann, who postulated the principle of "like cures like". In the nineteenth century, Hugo Paul Friedrich Schultz postulated that toxins can have the opposite effect in small doses compared to large doses. In 1888, Schultz showed that very low concentrations of yeast toxins increased yeast growth over 100 fold. At the same time, the psychiatrist Rudolph Arndt developed his "Basic Law of Biology," which states that weak stimuli slightly accelerate the vital activity, middle-strong stimuli raise it, strong stimuli suppresses it, and very strong stimuli halt vital activity. These separate observations were formulated by Arndt in 1888 into one of the earliest laws of pharmacology representing the homeopathic effect, the Arndt-Schultz rule, which states: every stimulus on a living


cell elicits an activity, which is inversely proportional to the intensity of the stimulus (Martius F., 1923, Das Arndt-Schultz Grundgesetz, Muench Med. Wschr., 70(31):1005-1006). This law was later restated by Ferdinand Hueppe as: for every substance, small doses stimulate, moderate doses inhibit, large doses kill. Allopathic medicine, with its emphasis on moderate drug doses, works to inhibit undesired physical symptoms and to kill undesired pathogens. Homeopathic medicine, on the other hand, begins with small doses and moves towards progressively higher dilutions to stimulate the body's own natural electromagnetic forces. One of the basic tenets of homeopathic medicine is that a cure for a disease can be evoked by using a high dilution medicine that resembles, yet is different from, the cause of the disease. Critical reviews of more than 100 controlled and/or clinical studies of homeopathy show that patients received positive healing benefits from homeopathy beyond the placebo effect e.g. Jonas et al, 2003, Ann. Intern. Med. 138:393-399; Linde et al, 1997, Lancet. 350(9081):834-843; Reilly et al, 1994, Lancet. 344:1601-1606); Kleijnen et al, 1991, Bmj. 910418 302(6772):316-323. Homeopathy is widely accepted as a useful therapeutic approach throughout Europe, N. America, the British Commonwealth countries, and India.
The development of the present invention also finds echoes in the system of Ayurveda - the Indian system of medicine, which has a tradition going back a few thousand years. Ayurveda mentions the effectiveness of minute doses of medicine in treating ailments. The word Ayurveda is made up of two basic terms viz. "AYU" and "VEDA" wherein "AYU" stands for life and "VEDA" means science or knowledge. Thus Ayurveda means "the science of life".
Ayurveda says there is not a single substance in this Universe which has no medicinal value. A "VAIDYA" (conventional name for a Doctor in Ayurveda) has to use his/her intelligence and keep on preparing newer combinations of remedies, i.e. "KALPA" to bring a state of health in patients or sufferers. Ayurveda says a substance works in the body by its properties i.e. "GUNA". The medicinal properties of a substance can be increased by subjecting it to various treatments i.e. "SANSKAR". Due to "SANSKAR", medicinal properties i.e. "GUNA" can be increased or decreased; sometimes "SANSKAR" can also alter the site of action of these substances inside the body. By subjecting the medicine to different treatments i.e. "SANSKARS", the medicine can be administered in minute doses i.e. "SOOKSHMA", which can even increase its effectiveness, while reducing the chances of side


effects. A medicine is called "SOOKSHMA" when it goes deep inside the body, or because of its fine size it enters the smallest "SROTASAS", which are the channels of circulation or tracts within the body. "SOOKSHMA" means minute quantity and minute size, and being so, it can be absorbed into the "SROTASAS" faster. "SROTASAS" are named so because of their tendency to trickle or ooze ("SRU" means flow) secretions through them (these secretions may be correlated with neurotransmitters). "SROTASAS" are the pathways for the nutrient products, waste products and "DOSHAS" during the process of metabolism ("DOSHAS" are explained in Ayurveda as entities, which when in equilibrium, the body is in good health; and when their equilibrium is disturbed, pathologies are produced in the body). While the basic sites of "SROTASAS" with different functions are fixed, their openings are innumerable, (these openings can be compared to connection of neurons at synapses.) A medicine is called "VYAVAYI", when a medicine before being assimilated in the gastrointestinal tract gets circulated in the complete body and then it is digested. Because of "VYAVAYI" property, a medicine is absorbed instantaneously and it goes to the minutest "SROTASAS" immediately and it acts immediately. A medicine is called "AASHUKARI" when after administration it spreads in whole body immediately and acts quickly.
According to basic principles of pharmacology in Ayurveda, when two medicinal substances having similar properties, i.e. "GUNAS" are combined together, it increases their potential (Synergism). Medicine should be given in such a manner that it will be pleasant to the mind. A medicine is ideal if it can be given in many ways and having many properties, i.e. "GUNAS". An ideal medicine should have following properties:
• Can be given in low dose
• Have immediate action
• Act on various pathologies ("DOSHAS")
• Is easily assimilable
• Is tasty
• Is pleasant
• And, able to cure the disease or pathology
According to Ayurveda, the treatment of neurological conditions should preferably involve ingredients which act as a gentle counterbalance to the neurological


symptoms, i.e. "SHAMANA CHIKITSA". This is done with the help of specific plants and body minerals that have action on neurological symptoms and conditions.
The combination of the present invention is based on the principle of synergistic effects of various homeopathic medicines that are complementary to each other, and taken together produce holistic healing and a unique treatment of various neurological disorders.
The development of the present invention is based on homeopathic principles. The potentized dilutions in the combination of the present invention act in small doses, and hence stimulate, according to Ferdinand Hueppe's law: for every substance, small doses stimulate, moderate doses inhibit, large doses kill. The potentized dilutions in the combination of the present invention also act on the principle of "like cures like". It is hypothesized that the ingredients of the present invention take care of action potentials which are required for nerve impulse transmission. It is also hypothesized that the homeopathically prepared minerals in the present invention restore the disturbed molecular motions of the minerals to their normal state. Also, it is hypothesized that the body salts in the present invention reactivate the chemical changes for neurotransmission, while the herbal extracts act as a catalyst to speed up the improvement. Possibly, the present invention removes blockage of synaptic levels or helps myelination.
The development of the present invention incidentally also finds echoes in the principles of Ayurveda as described above - for example, the combination has synergistic effect, it is prepared using a new combinations of remedies, ("KALPA"), is given in low dosage ("SOOKSHMA"), has an immediate action even before being assimilated in the gastrointestinal tract ("VYAVAYI"), spreads in the whole body immediately ("ASHUKARI"), is pleasant to take, and acts on various pathologies.
In this light, the present invention discloses the effectiveness on a number of cases of neurological disorders, and therefore represents a breakthrough in the medical field.
Details of preferred embodiment of the invention:
The individual ingredients of the preferred embodiment of the present invention are tinctures and/or homeopathic preparations selected from:


1) At least One ingredient selected from the group of homeopathic medicines acting on Nervous system (Neuritis - injuries of nerves and traumatic) from amongst: Allium Cepa, Arnica Montana, Bellis Perennis, Calendula Officinalis, Hypericum Perforatum, Phosphoricum Acidum
2) At least One ingredient selected from the group of homeopathic medicines acting on Nervous system (Paraplegia) from amongst: Aconitum Napellus, Alumina, Anahalonium Lewinii, Argentum Nitricum, Arnica Montana, Arsenicum Album, Belladonna, Caulophyllum Thalictroides, Causticum, Cocculus Indicus, Conium Maculatum, Cuprum Metallicum, Curare, Dulcamara, Formica Rufa, Gelsemium Sempervirens, Hypericum Perforatum, Kalium Iodatum, Kalium Tartaricum, Kalmia Latifolia, Lachesis Mutus, Lathyrus Sativus, Latrodectus Hasselti, Manganum Aceticum, Mercurius Corrosivus, Nux Vomica, Oxalicum Acidum, Phosphorus, Physostigma Venenosum, Picricum Acidum, Plumbum Aceticum, Rhus Toxicodendron, Secale Cornutum, Strychninum Purum, Thaelium Metallicum, Thyroidinum
3) At least One ingredient selected from the group of homeopathic medicines acting on Nervous system (Degeneration - multiple sclerosis) from amongst: Argentum Nitricum, Atropinum, Aurum Metallicum, Baryta Carbonica, Belladonna, Calcarea Carbonica, Causticum, Chelidonium Majus, Crotalus Horridus, Gelsemium Sempervirens, Lathyrus Sativus, Lycopodium Clavatum, Nux Vomica, Oxalicum Acidum, Phosphorus, Physostigma Venenosum, Plumbum Metallicum, Silicea Terra, Strychninum Purum, Sulphur, Tarentula Hispanica, Thuja Occidentalis
4) At least One ingredient selected from the group of homeopathic medicines acting on Locomotor system (Gait - walking, child slow to learn) from amongst: Baryta Carbonica, Calcarea Carbonica, Calcarea Phosphorica, Causticum, Natrium Muriaticum, Silicea Terra
5) At least One ingredient selected from the group of homeopathic medicines acting on Mind (Memory - forgetful, weak or lost) from amongst: Absinthium, Aconitum Napellus, Aethusa Cynapium, Agnus Castus, Alumina, Ambra Grisea, Anacardium Orientale, Anhalonium Lewinii, Argentum Nitricum, Arnica Montana, Aurum Metallicum, Azadirachta Indica, Baryta Carbonica, Calendula Officinalis, Calcarea Carbonica, Calcarea Phoshphorica, Camphora Officinalis, Cannabis Indica, Carbo


Vegitabilis, Cocculus Indicus, Conium Maculatum, Glycerinum, Ichthyolum, Kalium Bromatum, Kalium Carbonicum, Kalium Phosphoricum, Lac Caninum, Lachesis Mutus, Lecithinum, Lycopodium Clavatum, Medorrhinum, Mercurius Solubilis -Hydrargyrum, Natrium Carbonicum, Natrium Muriaticum, Nitricum Acidum, Nux Moschata, Nux Vomica, Oleander - Nerium Odorum, Opium - Papaver Somniferum, Phosphoricum Acidum, Phosphorus, Picricum Acidum, Plumbum Metallicum, Rhododendron Chrysanthum, Rhus Toxicodendron, Selenium Metallicum, Sepia Officinalis, Silicea Terra, Sulphur, Syphilinum, Tellurium Metallicum, Thyroidinum, Zincum Metallicum, Zincum Phosphoricum, Zincum Picricum
6) At least One ingredient selected from the group of homeopathic medicines acting on Mind (Speech - slow, difficult enunciation, inarticulate, stammering) from amongst: Aesculus Glabra, Agaricus Muscarius, Anacardium Orientale, Anhalonium Lewinii, Atropninum, Baryta Carbonica, Belladonna, Bothrops Lanciolatus, Bovista Lycoperdon, Bufo Rana, Cannabis Indica, Cannabis Sativa, Causticum, Cereus Serpentinus, Cicuta Virosa, Cuprum Metallicum, Gelsemium Sempervirens, Hyoscyamus Niger, Ignatia Amara, Kalium Bromatum, Kalium Cyanatum, Lachesis Mutus, Laurocerasus, Mercurius Solubilis - Hydrargyrum, Mygale Lasiodora, Naja Tripudians, Natrium Muriaticum, Nux Moschata, Oleander - Nerium Odorum, Opium - Papaver Somniferum, Phosphorus, Stramonium, Sulfonalum, Thuja Occidentalis, Vipera Berus
7) At least One ingredient selected from the group of homeopathic medicines acting on Mind (Brain Fag) from amongst: Aethusa Cynapium, Ailanthus Glandulosa, Alfalfa, Anacardium Orientale, Anhalonium Lewinii, Argentum Nitricum, Avena Sativa, Baptisia Tinctoria, Calcarea Carbonica, Calcarea Phosphorica, Coca -Erythroxylon Coca, Cocculus Indicus, Cuprum Metallicum, Gelsemium Sempervirens, Kalium Bromatum, Kalium Phosphoricum, Lecithinum, Natrium Muriaticum, Nux Vomica, Phosphoricum Acidum, Phosphorus, Picricum Acidum, Silicea Terra, Stychninum Phosphoricum, Zincum Metallicum, Zincum Phosphoricum, Zincum Picricum
8) At least One ingredient selected from the group of homeopathic medicines acting on Mind (Propensity - To be destructive, bite, strike, tear clothes) from amongst: Belladonna, Bufo Rana, Cantharis Vesicatoria, Cuprum Metallicum, Hyoscyamus


Niger, Lilium Tigrinum, Secale Cornutum, Stramonium, Tarentula Hispanica, Veratrum Album
9) At least One ingredient selected from the group of homeopathic medicines acting on Urinary system (Enuresis - Incontinence - Remedies in general) from amongst: Aconitum Napellus, Agaricus Muscarius, Apis Mellifica, Argentum Nitricum, Arnica Montana, Arsenicum Album, Atropinum, Belladonna, Benzoicum Acidum, Calcarea Carbonica, Cantharis Vesicatoria, Causticum, Cicuta Virosa, Cimicifuga Racemosa, Cina Maritima, Conium Maculatum, Dulcamara, Equisetum Hyemale, Eryngium Aquaticum, Eupatorium Perfoliatum, Eupatorium Purpureum, Ferrum Metallicum, Ferrum Phosphoricum, Gelsemium Sempervirens, Hydrangea Arborescens, Hyoscyamus Niger, Kalium Bromatum, Kalium Nitricum, Kalium Phosphoricum, Kreosotum, Linaria Vulgaris, Lupulus Humulus, Lycopodium Clavatum, Magnasia Phosphorica, Medorrhinum, Nux Vomica, Opium - Papaver Somniferum, Petroleum, Phosphoricum Acidum, Physostigma Venenosum, Plantago Major, Pulsatilla Pratensis, Rhus Aromatica, Rhus Toxicodendron, Sabal Serrulata, Sanicula Aqua, Santoninum, Secale Cornutum, Senega, Sepia Officinalis, Silicea Terra, Stramonium, Sulphur, Terebinthiniae Oleum, Thyroidinum, Thuja Occidentalis, Triticum Repens - Agropyrum Repens, Tuberculinum Bovinum Kent, Uranium Nitricum, Verbascum Thapsus, Zincum Metallicum
In accordance with one preferred embodiment of the invention, the formulation comprises:
1) Arnica Montana
2) Hypericum Perforatum
3) Causticum
4) Hyoscyamus Niger
5) Zincum Phosphoricum
6) Natrium Muriaticum
7) Calcarea Phosphorica
8) Kalium Phosphoricum
9) Ferrum Phosphoricum


The above ingredients of the present invention will work in the potency range of 30 - 1 m., but the actual potency may vary according to the requirements of the patient and condition.
Homeopathic ingredients of the present invention are non-toxic and do not produce undesirable side-effects. Each of the ingredients is also part of leading homeopathic pharmacopeia including the United States Homeopathic Pharmacopeia, Homeopathic Pharmacopeia of India, and the like. Some of the ingredients of the present invention are incidentally also in use in Ayurveda for many centuries. The formulation of the invention is prepared by adding the different ingredient dilutions in equal quantities to tablets/globules made from lactose or sucrose, which are readily available in the market. The dilutions of the homeopathic ingredients are preferably added till the tablets are thoroughly moistened. The available tablets are of various sizes. Typically three pills are given in the morning and/or evening, although the quantity/dosage is relatively unimportant. It is advisable that the mouth and tongue are clean and relatively odor-free to ensure maximum absorption and availability of the formulation. For this it is desirable that one should not eat or drink anything else for half an hour before and after intake of the formulation of the invention. It is also advisable that foods like non-vegetarian food and coffee and strong odor foods like raw onion or garlic should preferably be avoided to get the best results. However it is suggested that the key effectiveness of the present invention arises from the unique combination mentioned in the formulation. The formulation of the present invention can also be given as a complement to other forms of medicine or rehabilitation.
Study of treatment effects:
The formulation of the present invention was administered to 10 patients suffering from various neurological disorders over the last 10 months. The details of the results and the patients that were administered are presented below. All patients were video monitored. Opinions about improvements by therapists and parents were recorded. Nerve conduction velocity (NCV) study was conducted whenever necessary before and after treatment.
In all these patients, before starting the invention treatment, conventional treatments like Occupational Therapy, Speech Therapy, and Symptomatic drug


treatment were tried. The response seen after administration of the present invention treatment was much greater than with the previous conventional treatment indicating the efficacy of the invention. No side effects were seen in any of the patients. Following are details of improvements seen after administration of the present invention.
Patient 1: Male, 5 years old, was suffering from cerebral palsy spastic diplegia with a birth history of premature delivery at 7th month and having a low birth weight of 1.1 kg. He came with the following complaints: delayed motor milestones, partial bowel and bladder control. With 2 months of treatment with the present invention, his drooling was decreased, and his tendency of hitting his face with his hands decreased. In the 3rd month, tightness around hip joints decreased. His lateral cruising was better in the 6th month of treatment and he started showing inclination for academics.
Patient 2: Female, 9 years old, was suffering from microcephaly with mental retardation and delayed milestones. There was a history of delayed birth cry with low birth weight of 1.2 kg. Her Electro Encephelograph (EEG) was showing evidence of bilateral centro-temporal epileptiform activity, right more than left. But she was not given any anti-seizure medication ti!! then. She came with complaints of less balance while walking and speech was limited to the word "abba" (Indian word for father). She started responding significantly in only 1 month - her understanding improved, drooling was decreased, frequency of falling reduced, her head circumference increased from 43.8 to 44 cm. With 3 months of treatment, her balance improved further, she started climbing a few steps without support, started eating comparatively more tidily, with better chewing of food and started spitting out liquids while brushing her teeth. With 6 months of treatment, she showed global improvements in motor functions and cognitive functions, she started understanding a local language Marathi which she did not understand before, and she performed a good dance at school, stopped soiling her clothes, started to understand the difference between her belongings and those of others.
Patient 3: Female, 6 years old, was suffering from Attention Deficit Hyperactivity Disorder (ADHD). There was a family history of consanguineous marriage. She was brought to the clinic with complaints of mental subnormality and hyperactivity. She started responding in just 1 month of treatment, with improved understanding and


started following commands in a better way. She discontinued treatment after the 1st month for 4 months due to a cough and cold infection. Despite discontinuation of the treatment, her improvements continued in her tooth-brushing skills and developed color concepts. With 2 more months after resumption of treatment, her understanding improved further, she started identifying most of the pictures in books and started writing a few alphabets in Arabic script with a good finger-grip. But her hyperactivity continued as before.
Patient 4: Male, 8 years old, coming from a lower-income group, suffering from Microcephaly, with Attention Deficit Hyperactivity Disorder (ADHD) and delayed speech and language. The patient also had behavioral problems. With just 1 month of treatment, his hyperactivity was reduced, he started speaking many new words, starting calling his own name, his understanding was better and he was less irritable. With 3 months of treatment, his hyperactivity was further reduced, speech improved with more clarity, he was more independent in his dressing abilities, and his understanding was further better. With 5 months of treatment, his head circumference was found to have increased from 45.5 to 45.7 cms. He started speaking at 2-3 word level sentences.
Patient 5: Male, 9 years old, came with complaints of Attention Deficit Hyperactivity Disorder (ADHD), delayed speech and with a few autistic features. He was obsessive about playing with plastic articles such as bags, etc. There was a history of consanguineous marriage. Birth history was normal, but at the age of 6-8 months, there was an incidence of fall from his bed and then jerks started followed by regression in milestones. Scan was showing periventricular calcification. Electro Encephelograph (EEG) was showing right centro-parietal spikes. With 4 months of treatment his hyperactivity was less, he started sitting in one place for 15-20 minutes, obsession with plastic articles was reduced, and he started obeying some orders and started attempting to dress himself. He started to inform parents about his toilet needs. With 5 months of treatment, his facial expressions were better, previous improvements were maintained, he started brushing his teeth and taking bath. With 10 months of treatment, his previous improvements were maintained and he started obeying simple requests like bringing a glass of water, bringing the television remote control, etc.


Patient 6: Male, 15 years old with a diagnosis of cerebral palsy spastic diplegia. There was a history of premature delivery at 7 months of age, with low birth weight of 900 gms. There was also a history of neonatal jaundice. He came with complaints of unable to walk effectively and reduced fine-motor skills. With just 2 months of medicine, his kneel-standing balance improved. With 4 months treatment his bilateral hip extension improved and with 7 months of treatment, slightly better standing tolerance was seen.
Patient 7: Female, 4 years old with a diagnosis of right hemiplegic cerebral palsy. She had a normal birth history. When she arrived for treatment, her speech was unclear and right-sided movements were not upto the mark. With 1 month of treatment, her grip was better, and she was more cheerful. With 4 months of treatment, her spasticity was reduced, her walking was better, hand functions were better. At the end of the 5th month, her physiotherapist remarked "she has been doing very well in all aspects, has started stepping on her own on to a 7-inch high stool".
Patient 8: Female, 14 years old, with a diagnosis of microcephaly with seizure disorder, right hemiparesis and mental subnormality. The birth history was full-term delivery with delayed birth cry and low birth weight. She had jaundice after birth and from the 3rd month after birth onwards she had convulsions. She still gets convulsions at a gap of 2-3 months. Her scan was showing mild cerebral atrophy and Electro Encephelograph (EEG) was abnormal. She came with complaints of delayed motor milestones, poor scholastic performance with right-sided weakness. With 6 months of treatment, she could make use of her right hand and could hold and release her grip. Her understanding was improved, head circumference even at this age increased from 46 to 47 cms. Her myoclonic jerks were less than before.
Patient 9: Male, 4 years old with a diagnosis of macrocephaly with hypotonia and global developmental delay. The birth history was full-term delivery, lower caesarian section (LCSC) done due to large head. Birth cry was normal. There was a history of neonatal jaundice. He was well up to 3 months of age and then started getting myoclonic jerks. By the 6th month of age, he started losing his eye-contact and social smile. Magnetic Resonance Image (MRI) was showing dilated ventricles and EEG was abnormal. Metabolic screening tests were normal. He came with complaints of delayed motor, speech and mental milestones, seizure disorders and


there was no bladder-bowel control. His parents have reported that 1 week after starting the medicine, his limb movements increased, his looks and expressions became more meaningful and he "is trying to be happy and enjoying all his time. He is expecting pampering and people to talk to him and attend him". With 5 months of treatment, he became more active, started recognizing parents and grandparents, making continuous noises, visual tracking of objects improved, and sitting balance became better when made to sit. His supported-standing balance was slightly better and he was better emotionally and understanding improved.
Patent 10: Male, 57 years old, came with a history of numbness in the area of radial half - palmer aspect of hand, weakness of right arm, joint deformity of right index finger with diminished grip strength in both arms. The problem started about 2.5 years back with right shoulder pain. On investigation, Magnetic Resonance Image (MRI) of cervical region was showing cervical extensive spondiloarthopathy showing: 1) C5/6 level bilateral foraminal stenosis due to osteophytes, compression of right exiting C6 and bilateral exiting C7 nerve roots as well as diffuse posterior disk osteophyte complexes causing degenerative central canal stenosis at these levels. 2) No cervical compressive myelopathy seen. He was operated in December 2005 for decompression. Before starting treatment with the present invention his nerve conduction velocity (NCV) study was showing evidence of motor nerve degeneration in muscles of both upper limbs (more severe on the right) at root, anterior horn cell level. With 4 months of treatment, his pain in the right index finger was less. With 6 months treatment, his repeat NCV study was showing the motor activities in biceps and dorsal interossi showed improvement. With 9 months of treatment, his grip strength was much better. Considering his diagnosis of anterior horn cell level lesion, these improvements with 6 months of treatment are significant and show objective evidence of regeneration with NCV study.
The results show that the present invention has beneficial effects on motor and higher mental functions and can significantly improve the quality of life of patients with neurological disorders.
How the invention acts:
It has been postulated that in the case of homeopathy, highly dilute compounds transfer biological activity to cells by electromagnetic fields (Benveniste, 1993,


Frontier Perspec. 3(2): 13-15). Further it has been hypothesized by Del Giudice et al in the case of homeopathic formulations that interactions between the electric dipoles of water and the radiation fields of a charged molecule generate a permanent polarization of water that becomes coherent and has the ability to transmit specific information to cell receptors (Del Giudice, E., Preparata, G., Vitiello, G., 1988, Phys. Rev. Lett. 61:1085-1088). The positive benefits of the homeopathic method of treatment are well documented and also account for the tremendous popularity of homeopathy worldwide.
Based on the observations of patients, it can be suggested that the present invention is probably acting on the neurotransmitters or nerve growth factor. Also it is hypothesized that the body salts in the present invention reactivate the chemical changes for neurotransmission, while the herbal extracts act as catalyst to speed up the improvement. Possibly, the present invention removes blockage of synaptic levels or helps myelination.
None of the individual ingredients of the present invention have been described to have a treatment action on specific neurological disorders like Cerebral Palsy, Mental Subnormality, Autism, and the like. Hence, the present invention, having a widespread positive action on different neurological disorders, is indeed unique. The formulations of the present invention also do not require casework diagnostics to attempt to discover the similimum (remedy most resembling patient's symptoms) and then attempt to prescribe the correct potency, duration and dosage. Hence, the present invention is a common formulation for several neurological disorders mentioned, and no drug individualization using single drug ingredient per dose as practiced in classical homeopathy is required. All ingredients of the present invention are complementary to each other according to the Homeopathic Pharmacopeia and the individual components are in use in Homeopathy and some in Ayurveda for many years.
While the preferred embodiment mentioned earlier might offer the best results for the aforementioned neurological disorders, it is expected that the there are other possible variations of the preferred formulation of the invention that are expected to also have good therapeutic properties. The homeopathic formulations of the invention can be varied in terms of the potencies and doses, or in terms of the ingredients. The homeopathic formulation of the invention can be administered


either in alcoholic or non-alcoholic form. Each of the ingredients in the formulation of the invention may also be given in potencies ranging from lower potencies including tincture to higher potencies of 50 m and above. The preferred homeopathic formulation of the invention comprises 9 different ingredients. Some of the formulations of the invention can also be made by not using one or more of the 9 ingredients. As one or some of the 9 ingredients are excluded from the formulations, the formulations will still have effective properties. The homeopathic formulation of the invention can comprise 8 ingredients, 7 ingredients, 6 ingredients or 5 ingredients. However, each omission of an ingredient from the list of 9 slightly lessens the total product effectiveness. The formulation of the invention may be combined with other treatment methods and substances used in the treatment of neurological disorders including allopathic medicines, vitamins, minerals, amino acids, traditional homeopathic remedies, inert substances, etc. The individual components could be given in potentized forms and also in other forms such as, but not limited to, mother tincture, biotechnology form, nanotechnology form, etc. The individual components of the treatment may be administered all together at the same time and/or in various permutations and combinations, for example a few ingredients could be administered together at one time, and the others at a different time, etc. Additional components could be added to the treatment that could increase its effectiveness or allow it to function with the same level of effectiveness.
Variations of drug delivery method:
Oral dosage is the preferred method of delivering the formulation of the invention. The active ingredients of the homeopathic formulations may be used with any of the standard delivery systems used in oral homeopathy in any acceptable combination such as: sugar pills, tablets, drops, pills, water, glycerin, milk sugar and cane sugar vehicles, alcohol, medicated powders, medicated globules (pellets, pilules), cones, etc. The active ingredients of the homeopathic formulations may also be administered through inhalation, topical application on skin, administered parenterally, such as intravenously, or with any other method of homeopathic and/or herbal and/or allopathic drug administration, such as intramuscular, intracutaneous, intravenous or subcutaneous injections. Other possible drug delivery methods include implanting a pump or other instrument to deliver the said formulation in the body, drug delivery systems used in modern medicine,


biotechnology, nanotechnology, etc. The formulation could also be taken nasally, or as eyedrops, or eardrops or in the form of a suppository or a patch. For each of these different delivery methods, the formulation would have to be of course prepared in an appropriate potency, and carried in a safe and effective base as, for example, described in OTC, HPUS and other medical literature.
While considerable emphasis has been placed herein on specific ingredients of the formulation, it will be appreciated that many changes can be made in the preferred formulation without departing from the principles of the invention. These and other changes in the preferred invention will be apparent to those skilled in the art from the disclosure herein, whereby it is to be distinctly understood that the foregoing descriptive matter is to be interpreted merely as illustrative of the invention and not as a limitation.