|Title of Invention||
MEDICINAL FORMULATION CONTAINING A MIXTURE OF HIV TYPE I AND HIV TYPE II FOR TREATMENT OF AUTOIMMUNE DISEASES
|Abstract||A novel medicinal formulation for the treatment of autoimmune diseases, said formulation comprising, combined serially diluted and potentized HIV TYPE I virus and HIV TYPE II virus, said dilution effected in a vehicle selected from a group consisting of distilled water or ethyl alcohol and mixture of distilled water and ethyl alcohol.|
THE PATENT ACT, 1970
(39 of 1970)
THE PATENT RULES, 2003
(See section 10 and Rule 13)
DR. SHAH RAJESH
An Indian National
of Life Force Center, 415, Commercial Complex, 4th Floor,
Above Shopper's Stop, G.M. Road, Chembur,
Mumbai-400 089, Maharashtra, India.
THE FOLLOWING SPECIFICATION DESCRIBES THE INVENTION
This invention relates to a medicinal formulation.
Envisaged in accordance with this invention is a formulation containing a combination of HIV Type I and HIV Type II containing preparations.
Experimentation carried out by the inventor whereby both the preparations were used in combination, produced much better and more predictable results.
Logically, the use of the formulation in accordance with this invention offers a wider antigenic action and in turn, broader immune reaction leading to superior applicability in terms of effective and faster results. HIV Type I and HIV Type II
Field of invention
The present invention relates to a novel medicinal formulation for triggering certain immune response which may lead to therapeutic and prophylactic measures in the treatment of various immunologically mediated diseases such as HIV infection, Psoriasis, Allergic disorders, auto-immune diseases, viral infections, collagen diseases and various opportunistic infections..
As used in the present specification, the following words and phrases are generally intended to have the meanings as set forth below, except to the extent that the context in which they are used indicates otherwise.
HIV: Human immunodeficiency virus (HIV) is a retrovirus that causes Acquired Immunodeficiency Syndrome (AIDS), a condition in which the immune system fails to function which results into life-threatening opportunistic infections.
HIV-I (HUMAN IMMUNODEFICIENCY VIRUS TYPE 1): The retrovirus isolated and recognized as the etiologic agent (cause) of AIDS. HIV-1 is classified as a lentivirus in a subgroup of retroviruses. Most viruses and all bacteria, plants, and animals have genetic codes made up of DNA, which uses RNA to build specific proteins. The genetic material of a retrovirus such as HIV is RNA. HIV inserts its own RNA into the host cell DNA, preventing the host cell from carrying out its natural functions and turning it into an HIV "factory."
HIV-II (HUMAN IMMUNODEFICIENCY VIRUS TYPE 2): This virus is closely related to HIV-1 that also causes AIDS. It was first isolated in West Africa. Although HIV-1 and HIV-2 are similar in their viral structure, modes of transmission, and resulting opportunistic infections, they differ in their geographic patterns of infection.
CD4 cells CD4 count: CD4 cells are helper T cells which are infected by HIV virus. HIV infection leads to low levels of CD4 count. When the CD4+ T cell numbers decline below a critical level, body's cell-mediated immunity is lost, and the body tehn becomes more susceptible to opportunistic infections.
CD8 count: CD8 are the suppressor T cells, which are are lymphocytes (white blood cells), formed in the thymus and are part of the immune system. They have been found to be abnormal in persons with AIDS. The normal ratio of helper T cells (CD4 cells) to suppressor T cells (CD8 cells) is approximately 2.
The CD4/CD8 ratio: This is an indicator of the overall level of immune suppression or damage done by HIV. The lower the CD4/CD8 ratio, the worse the damage. The CD4/CD8 ratio is rarely less than 1.0 in HIV negative individuals, but may drop as low as 0.1 in patients with recent HIV
infection or very advanced disease. The CD4/CD8 ratio will generally gradually decline over years of HIV infection in the absence of antiretroviral
Potency: Potency is an unit of the dose of homeopathic medicine. Usually denoted as 'c' or centesimal potency, which means that the said preparation has been made using the ratio of the original substance (1 part) to the vehicle 99parts (non-medicated substance, mostly ethyl alcohol (90 to 100%), normal saline or distilled water). It may be noted that there may be some variation in this ratio, which is not likely to alter the efficacy of the medicine. An alternative method is based on the use of 1:10 ratio and it is denoted as 'x' or decimal potency.
Background and Prior Art:
HIV infection in humans is considered as one of the most destructive pandemics ever affected the humans. It is estimated that about 0.6% of the
world's living population is infected with HTV. A third of these deaths are occurring in sub-Saharan Africa, retarding economic growth and increasing poverty. According to current estimates, HIV is set to infect 90 million people in Africa, resulting in a minimum estimate of 18 million orphans. Antiviral
The current treatment entails antiretroviral treatment, which helps to certains extent; very expensive and have adverse effects. There is no vaccine available for HIV as on now. There are no therapeuticv measures prepared using the HIV type I and type II virus for the treatment of HIV infection or other disease conditions.
Use of nosodes in homeopathy: Nosodes are the drug substances used in homeopathy since the early part of the 19th century; whereby an infinitesimal part of the original diseased tissues or organisms (bacteria or virus) are used by the method called potentisation, which entails mixing of 1 part (say 1ml of serum contaning organisms) with 99 parts of non-medicated vehicle (water or alcohol) and exposing the content to powerful striking (about 10 times) on hard surface, by holding the bottle in the fist. This process can also be done with the help of a mechanical devices which may allow such mechanical hard-hitting. This procedure is called as potentisaiton. One such round of 10 to 15 strokes given to the bottle which has substance in the ratio of (about) 1:99 leads to the drug substnace whose power is lc or 1 centicimal potency. Such a procedure is repeted for 30 times (30c potency),
100 times (100c potency), 200 times (200c potency) 1 million times (One
million c potency).
The nosodes prepared from various diseased products and infected disease material have been found to be useful in homeopathic practice. Despite the fact that they are prepared from various infective agents such as Mycobactrium tuberculosis, Rabies virus, etc. they are free from side effects and their safety is well established.
The prepration of nosodes derives from homotoxicology, a type of homeopathic therapy created by Hans-Heinrich Reckeweg in Germany in the first part of 18th century.
Homeopathic medicine, since its inception under Hahneman at the beginning of the 19th century, follows the principle of "infinitesimals." From this notion, the dosages of nosodes are in very minute and diluted forms. Thus, nosodes are not nearly as harmful as the untreated pathological product.
A 'nosode' is similar to an "oral vaccine" in the sense that its purpose is to "immunize" the body against a specific as well as related disease conditions. The major difference between a nosode and a vaccine is, of course, the extremely small quantity of antigenic material in a nosode.
In the case of nosodes from bacteria, viruses or diseased tissues, the preparation introduces the molecular imprints of possible antigens and other constituents of the pathological agent to the immune system. The working of the nosode is based on the fact that the immune system is induced to develop a defense mechanism which is effective against variety of antigens
with this kind of molecular imprint, without being exposed to the virulence of the living agent.
Nosodes are also used as inter-current remedies in the treatment of chronic diseases.
At present, there is no nosode prepared from the saline of patient suffering from HIV Type I and HIV type II. The most suitable source for the HIV Type I and II nosodes is the saline of patients who were detected positive for HIV Type I and II respectively and they should be negative for other similar infections such as Hepatitis C, herpes, etc.
The current Patents of HIV type I and HIV type II have been registered separately by Dr Rajesh Shah, India. However, as the experience has evolved suggesting that the combination of HIV type I nosode with HIV type II nosode is more effective than the individual preparation.
Objective of invention:
The objective of this invention is to provide a novel, broad spectrum immunity enhancing, immunity correcting, reliable medicinal formulation prepared from the combination of both the HIV virus types, namely, HIV type I and HIV type II, prepared from the separate sera of patients suffering from HIV Type I and HIV Type II infection respectively. It was made sure that both the patients were negative for Hepatitis C and Herpes infections.
The objective of this invention is to use the preparation for the treatment of patients who have HIV infections and AIDS. It is anticipated that the said preparation may be able to stimulate the immune system due to its potent and subtle antigenic action, whereby the viral load of HIV virus (Type I and II) may get lower with its use. Similarly, CD4 count increase and improvement of CD4/CD8 count ratio may be achieved.
Yet another objective is to use this preparation for post-exposure prophylaxis for the treatment of HIV infections as well as to explore its application as a potential vaccine like preparation.
Yet another objective is to use this preparation for the treatment of various immunologically mediated disorders such as Psoriasis, Rheumatoid Arthritis, Lichen Planus, etc. by correcting the immune status of such patients.
Yet another objective is to use this preparation for the treatment of various viral infections such as Molluscum contagiosa, herpes genitalis, etc. by stimulating antiviral activities in the body.
Yet another objective is to use this preparation for the treatment of collagen diseases such as Rheumatoid Arthritis, Ankylosing Spondylitis, etc.
Yet another objective is to use this preparation is to reduce levels of various cytokines such as IL 8, Tumor Necrosis Factor alpha, Interferon y (gamma) (IFN-y) which are important mediators of immunological diseases such as
Psoriasis, Alopecia areata, Rheumatoid Arthritis, Ulcerative colitis, Lichen Planus, Vitiligo, Cancer, etc.
Yet another objective is to use this preparation is to control and prevent opportunities infections in patients who have HIV infection.
Yet another object of this invention is to provide a method for preparation of a novel formulation, potentised by means of a mathematico-mechanical process for maximal therapeutic benefits.
Yet another object of this invention is to provide a novel medicinal formulation which is reproducible and which contains precisely defined antigenic material.
Particularly envisaged in accordance with this invention is a safe medicinal formulation containing serially agitated dilutions of mixture of antigens from aforementioned strains of HIV type I and II.
The composition of this invention referred to as HIV compound, the combination of HIV Type I and HIV Type II, has been found to be effective in the treatment of various immunologically mediated diseases, autoimmune diseases, collagen diseases, viral infections. Its role seems potential in the treatment of AIDS as therapeutic as well as post-infection prophylactic, whereby it could reduce the viral load as well as increase the CD4 count and CD4/CD8 ratio.
- There is no such known therapeutic measure comparable with the HTV compound prepared from the HIV type I and II virus; used for HIV infection as well as for extra-HTV infection related ailments.
The exact mechanism of its action required to be explored. However, HIV compound seems to be working by triggering specific immune response against HIV and general immune response whereby it could help various immunologically mediated diseases.
This HIV compound may broadly be compared with HIV vaccine.
The HIV compound has also been found to be effective for ailments other than the AIDS. This compound may be administered repeatedly and in same or different potency (power or dose) over the period of time, without any adverse effects.
HIV compound is sourced from both the HIV types, that is HTV type I and HIV type II; that is, it has wider application and efficacy.
Procedure of collection:
Samples of Serum of patient who was HIV Type I positive was collected from a reputed laboratory. Similarly, another sample of another patient who was positive for HIV Type II was also collected. It was made sure that both the samples were positive only for the respective HIV Type and they were
not positive for the other HIV type. It was also confirmed that both the
samples were negative for other related viral infections such as Hepatitis C and Herpes genitalis. This procedure confirmed that the said sera had only the specific virus and had no contamination with other known virus. The samples were labeled as HIV Type I and HIV Type II.
Procedure of preparation of medicine from HIV virus:
HIV Type I: One milligram of serum which must have contained several m millions of HIG Type virus was taken from this bottle and mixed with about 100 drops of distilled water in another bottle. It may be noted that any minor variation in the serum quantity (1ml or more or less) and in the quantity of distilled water (100 drops or more or less) would not change the efficacy of the ultimate product not would it alter the originality of the product. Also, in this case, distilled water is considered as non-medicated vehicle, which may be replaced with any non-medicated substances such as ethyl alcohol or any such substance, which may not alter the effect of the original substance.
This bottle thus prepared was labels as bottle 'HIV Type I'. It was a vial 10 ml size.
It may also be noted that this initial procedure of the use of the infected serum from the patient may be replaced by using the colonies of HIV virus, whenever it may be possible to do so in future. At this time, there is no facility to have a culture of HIV virus.
HTV Type II: The procedure as above was repeated using serum of HIV type
II positive patient.
This bottle thus prepared was labels as bottle 'HIV Type IF. It was a vial 10 ml size.
i. The bottle labeled 'HIV Type F was held firmly in a closed fist (taking all
aseptic precautions) and stricken very hard on a hard surface from distance
of about two feet. This procedure was repeated 10 times. This simple
procedure led to very vigorous shaking of the bottle content. This bottle was
labeled as 'HIV Type I - lc\ (lc = 1 centesimal), where lc denotes the first
level of power or dose of the preparation.
ii. One drop from the bottle labeled as 'HIV Type I - lc' is now mixed with
about 99 drops of alcohol or distilled water, in another bottle. This new
bottle is now exposed to the same procedure of vigorous shaking as above,
10 times and the resultant bottle is now labeled as 'HIV Type I - 2c'.
It may be noted the manual procedure of vigorous shaking by giving powerful strokes may be replaced by any mechanical (or electromechanically) device which might do a similar job, saving human efforts involved in the process. Also, any use of such a device may not be claimed as originality of the product, as it is just the means of procedure.
Also, any variation in the number of strokes from 10 to 100 or more or less, also would not add to any originality in the procedure.
ii. Similarly, HIV Type II- 2c was prepared.
i. The procedure was repeated to prepare HIV Type I - 3c, HIV Type I -
HIV Type I - 100c... HIV Type I - 1000c... HIV Type I - 1 million c and
ii. The procedure was repeated to prepare HIV Type II - 3c, HIV Type II -4c...HIV Type II- 100c... HIV Type II- 1000c... HIV Type II- 1 million c and more.
The final products, preparations from two different virus sources are now ready for future.
These preparations are in incredibly minute dose, which are devoid of any virus or any disease-producing properties of the original organisms. These preparation are safe and free from known side effects.
It may also be noted that the homeopathic medicines thus prepared in the 15c or more potency, the scientists have not been able to find any molecule of the original substance when examined with the latest of electron microscope. In other words, such preparations beyond 15c potency, are from any toxicity.
It may be noted that several toxic substances such as Arsenic, potassium
iodide, hydrocyanic acid, snake venom, etc. are in use in homeopathy since
over 100 years, and they have been found to be free from their original toxicity. Such apparently toxic products are legally sold over the counter in most countries.
It may be noted that the proportion of mixing of primary serum with the vehicle can range from 1:99 to 50:50. Preferably 1ml of the primary culture is mixed with 90 ml of the vehicle.
Although the dilution represented by the term 'c' means a dilution of 1:99, for the purposes of this specification the term 'c' is deemed to mean any dilution in the range of 1:99 to 50:50.
The HIV compound:
The inventor of HIV Type I and HIV Type II experimented with the
individual components in several patients. However, in a study, it was
observed that when used in combination of two identical (or different)
potencies, the results were much better. That is, instead of using HIV Type I
50c, if it was combined with HIV Type II 50c, or similar potency; the results
were faster and better.
Based on this experience, the HIV compound was prepared whereby any two equal (of separate) potency was administered at the same time to patients. For example, HIV Type I- 50c combined with HIV Type II- 50c or combined with HIV Type 11-100 c, etc.
It may be noted that there may be several combinations and permutations possible while using the HIV compound.
About the potency:
Homeopathic medicines prepared from the diseased body tissues or organisms are prescribed to patients in various potencies, as per the well defined parameters of potency selection. Some of the parameters may be described in brief hereunder:
1. Age: Younger patients with higher susceptibility may be prescribed medium to high potency such as 30c to 1000c.
2. Functional pathology: Patients with functional disorders are prescribed medium to high potency.
3. Structural pathology: Patients with structural pathology are prescribed low potency to start with.
4. Nosode: When used as a nosode, 30c potency is the ideal in it can be stepped up slowly.
5. Response: In case there is no response or the remedy stops acting, the potency can be stepped up from 30c to 50c to 100c to 500c.
6. Active pathology: In case of active pathology such as tubercular cavities or ulcers, higher potencies should be avoided.
7. Susceptibility: Higher the susceptibility, higher the potency.
8. Newer medicines in their initial evaluation period are better prescribed in 30c potency, if they are prepared from organism, venoms or any toxic source.
Serial Dilution And Potentization :
Further to the procedure explained above, it may be noted as under.
Potentization is a mathematico-mechanical process for rendering inert or poisonous antigen containing pathological residues, to a state of physical solubility, physiological assimilability so as to enhance their therapeutic activity and harmlessness, for use as a healing remedy.
The primary object of potentization is to reduce all substances designed for therapeutic use to "a state of approximately perfect solution or complete ionization, which is fully accomplished only by infinite dilution." (Arrhenius.)
Each resulting diluted culture is potentised typically by stroking by holding the bottle in a closed fist and striking the fist on a hard surface repeatedly at a regular frequency or by exercising similar powerful stroke using a mechanical device which can strike a bottle on a hard surface. Such strokes are given about 10 times.
Advantage and Application of the new preparation HIV compound:
These preparations are prepared from the specific HIV virus types but they lack the viral toxicity.
Preliminary clinical investigations have shown that the formulations prepared according to the above process help to retain the capacity to induce immune response in the body, which helps in treating a wide range of immunologically mediated diseases.
HTV Type I and II serum was procured from Hidusabha Hospital, Ghatkopar East, Mumbai, India; of patients who were respectively HIV Type I and Type II positive.
Note on the combination of HIV Type I and Type II:
The investigator, who also has patent pending for HIV Type I as well as for HIV Type II preparations, has experimented with both the versions separately in a series of cases. The results were good. However, when the investigator carried out a study whereby both the preparations were used in combination, they produced much better and more predictable results.
Logically, the use of both the preparations offer a wider antigenic action and in turn, broader immune reaction leading to superior applicability in terms of effective and faster results.
34 year old male with Psoriasis since 1 and Vi months Moderately severe lesions.
No remission. History of similar complaints 7 years ago. HIV TYPE I and HIV TYPE II given in 50 potency. Patient recovered 90-95% in a period of 2 months. Almost complete recovery after 5 months of treatment.
30 year old male with Psoriasis since 8 months
HIV TYPE I and HIV TYPE II given in 50 potency. Later in 100, 200 and
Patient recovered 60% in a period of 12 months. Discontinued treatment thereafter.
22 year old male with Psoriasis since 1 month
Mild to moderate lesions.
HIV TYPE I and HIV TYPE II given in 35 potency. Later in 200 potency
After an initial aggravation for 6 weeks, patient started improving. Within
the next 9 months, he cleared up almost completely.
21 year old male with Psoriasis since 15 years
Masked lesions. (Mild)
HTV TYPE I and HIV TYPE II given in 50 potency. Later in 200 potency.
Patient recovered almost completely in a period of 9 months.
44 year old male with Psoriasis since 13 years
Remission once for 5 years.
HIV TYPE I and HIV TYPE II given in 50 potency.
Patient recovered 75% in a period of 3 months.
35 year old male with Psoriasis since 8 years
HIV TYPE I and HIV TYPE II given in 200 potency.
Patient recovered 90% in a period of 3 months.
56 year old male with Psoriasis since 25 years Extensive lesions.
Spontaneous remissions 2-3 times (lasting for 1-2 months) HTV TYPE I and HIV TYPE II given in 200 potency. Patient recovered 75-80% in a period of 6 months.
38 year old female with Psoriasis since 2 years
HIV TYPE I and HIV TYPE II given in 50 potency.
Patient recovered almost completely in a period of 5 months.
30 year old female with Psoriasis since 15 years
HIV TYPE I and HIV TYPE II given in 50 potency. Later in 100 potency.
Patient recovered more than 90% in a period of 10 months.
5 and ½ year old male with Psoriasis since 2years
Remission 2-3 times (each lasting about 2 weeks)
HTV TYPE I given in 35 potency and he was 75% better with this in 1
month. Later HIV TYPE I and HIV TYPE II given together when his
complaints started increasing again.
Patient recovered almost completely after treatment for another 3 months.
Application and usage of HIV TYPE I and HIV TYPE II combination:
The said preparation of combination is found to be useful and its scope requires further exploration for the following conditions:
1. Various immunologically mediated diseases like Psoriasis, Eczema, allergic disorders, auto-immune diseases, etc.
2. Viral infections such as herpes genitalis, herpes zoster, AIDS, etc.
3. Therapeutic and prophylactic use in cases of HIV infections and AIDS
4. Collagen diseases
5. Various other chronic diseases
Dated this 21st day of February, 2007
of R. K. Dewan &Co Applicant's Patent Attorney
|Indian Patent Application Number||347/MUM/2007|
|PG Journal Number||46/2010|
|Date of Filing||21-Feb-2007|
|Name of Patentee||DR. SHAH RAJESH|
|Applicant Address||LIFE FORCE CENTER, 415, KRUSHAL COMMERCIAL COMPLEX, 4TH FLOOR, ABOVE SHOPPER'S STOP, G. M. ROAD, CHEMBUR, MUMBAI-400089,|
|PCT International Classification Number||A61K39/12|
|PCT International Application Number||N/A|
|PCT International Filing date|