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A Polynosodic Homeopathic Composition

Abstract: The present disclosure relates to a polynosodic homeopathic composition comprising a homogenized mixture of a potentized polynosode and a vehicle. The polynosode is obtained from virulent strains of a plurality of pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans. The ratio of the potentized polynosode to the vehicle is 1:9 for 1X potency and 1:99 for 1C potency. The polynosodic homeopathic composition of the present disclosure has effective prohibition of diseases that occur due to different pathogens in a single administration, thereby making it economical for the patient and increasing patient compliance. The present disclosure also relates to a process for preparing a polynosodic homeopathic composition.

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Notices, Deadlines & Correspondence

Patent Information

Application #
Filing Date
13 September 2019
Publication Number
12/2021
Publication Type
INA
Invention Field
BIOTECHNOLOGY
Status
Email
dewan@rkdewanmail.com
Parent Application

Applicants

RAJESH SHAH
LIFE FORCE CENTRE, 415, KRUSHAL COMMERCIAL COMPLEX, 4TH FLOOR, ABOVE SHOPPER'S STOP, G.M. ROAD, CHEMBUR MUMBAI-400 089, MAHARASHTRA, INDIA

Inventors

1. RAJESH SHAH
LIFE FORCE CENTRE, 415, KRUSHAL COMMERCIAL COMPLEX, 4TH FLOOR, ABOVE SHOPPER'S STOP, G.M. ROAD, CHEMBUR MUMBAI-400 089, MAHARASHTRA, INDIA

Specification

Claims:
WE CLAIM:

1. A polynosodic homeopathic composition comprising a homogenized mixture of:
a. a potentized polynosode; and
b. a vehicle;
wherein the potentized polynosode is obtained from virulent strains of a plurality of pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans; and wherein the ratio of the potentized polynosode to the vehicle is 1:9 for 1X potency and 1:99 for 1C potency.

2. The composition as claimed in claim 1, wherein the virulent strains of Escherichia coli is at least one selected from the group consisting of Escherichia coli ATCC 11775, Escherichia coli ATCC 25922, Escherichia coli ATCC 8739, Escherichia coli (ECECO-COMB) and Escherichia coli (ECCOMB).

3. The composition as claimed in claim 1, wherein the virulent strains of Salmonella typhi is at least one selected from the group consisting of Salmonella enterica subsp. enterica serovar Typhimurium ATCC 51812, Salmonella enterica subsp. enterica serovar Typhimurium ATCC 13311, Salmonella Typhimurium (STCOMB) and Salmonella Typhimurium (STETCOMB).

4. The composition as claimed in claim 1, wherein the virulent strain of Klebsiella pneumoniae is Klebsiella pneumoniae ATCC BAA-2146.

5. The composition as claimed in claim 1, wherein the virulent strain of Neisseria gonorrhoeae is Neisseria gonorrhoeae ATCC 43069.

6. The composition as claimed in claim 1, wherein the virulent strains of Candida albicans is at least one selected from the group consisting of Candida albicans ATCC 24433, Candida albicans ATCC 26790, Candida albicans ATCC 60193 and Candida albicans (CANACOMB).

7. The composition as claimed in claim 1, wherein the vehicle is selected from the group consisting of alcohol, water and sachhrum lactose.

8. The composition as claimed in claim 1, for use in the treatment of diseases or disorders associated with pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans.

9. A process for preparing a polynosodic homeopathic composition, the process comprising the following steps of:
a. preparing a polynosode by:
• isolating virulent strains of a plurality of pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans;
• cultivating the isolated virulent strains on a suitable growth medium to obtain cultured strains;
• triturating the cultured strains with a vehicle to obtain the polynosode, wherein the ratio of the cultured strains to the vehicle is in the range of 1:99 to 50:50;
b. potentizing the polynosode by serially diluting and succussing the polynosode in the vehicle to obtain a potentized polynosode having potency in the range of 1C to 1 million C;
c. iterating the step (b) for 30 to 10,000 times to obtain the polynosodic homeopathic composition;
wherein the potency of the composition is in the range of 30C to 10,000C.

10. The process as claimed in claim 9, wherein the vehicle is selected from the group consisting of alcohol, water and sacchrum lactose.

11. The process as claimed in claim 9, wherein the vehicle for the trituration in step (a) is sacchrum lactose.

12. The process as claimed in claim 9, wherein the vehicle for the potentization in step (b) is selected from alcohol and water.

13. The process as claimed in claim 9, wherein the potentization in step (b) is performed using an electro-mechanical potentizer.

Dated this 13th day of September, 2019


MOHAN DEWAN (IN/PA-25)
of R.K. DEWAN & COMPANY
APPLICANT’S PATENT ATTORNEY

TO,
THE CONTROLLER OF PATENTS
THE PATENT OFFICE, AT MUMBAI
, Description:FIELD
The present disclosure relates to a polynosodic homeopathic composition.

DEFINITIONS
As used in the present disclosure, the following terms are generally intended to have the meaning as set forth below, except to the extent that the context in which they are used indicate otherwise.
Centesimal Potency: The term “centesimal potency” refers to the principle that the first potency must contain one-hundredth part of the original drug and each succeeding potency must contain one-hundredth part of the preceding one. This scale is designated by suffixing the letter 'C' or 'CH' to the number indicating the potency, i.e., the first potency is 1C or 1CH, followed by 2C or 2CH and so on.
Decimal Potency: The term “decimal potency” refers to the principle that the first potency should contain one-tenth part of the original drug and each succeeding potency should contain one-tenth part of the potency preceding it. The decimal potency is denoted by suffixing the letter 'X' or 'D' to the number indicating the potency, i.e. the first potency is 1X or 1D in the decimal scale, followed by 2X or 2D and so on.
Nosode: The term “Nosode” refers to a very dilute and potentized pathological tissue sample taken from the blood, feces, mucus, pus or tissue of an affected body part or organism such as bacteria, virus or parasites and administered to a human to promote immunity against disease.
Polynosode: The term “Polynosode” refers to a polynosodic homeopathic composition comprising more than one nosode.
Potentization: The term “potentization” refers to the process of making a polynosodic homeopathic composition more potent by serial dilution and succussion. Potentization is the process for the reduction, according to scale, of crude, inert or poisonous medical substances to a state of physical solubility, physiological assimilability and therapeutic activity and harmlessness for use as homeopathic healing remedies.
Succussion: The term “succussion” refers to the vigorous shaking of a diluted homeopathic composition in order to activate the medicinal substance. Succussion is the process of potentization, by which preparation of the composition takes place by the use of a liquid vehicle like alcohol or water and by shaking in a definite method.
Trituration: The term “trituration” refers to grinding one compound into another to dilute one of the ingredients, add volume for processing and handling or to mask undesirable qualities.

BACKGROUND
The background information herein below relates to the present disclosure but is not necessarily prior art.
Nosode is a composition made from diseased or pathological tissues. Substances such as bacteria, virus, hormones as well as tissue and blood products are used in the fabrication of nosodes. Nosodes such as Tuberculinum, Carcinosinum, Medorrhinum, Psorinum, etc. play an indispensable role in the treatment of acute as well as chronic diseases such as tuberculosis, cancer, gonorrhea, skin diseases, metabolic diseases or other acute or chronic diseases.
Five major pathogens which commonly affect the gastrointestinal tract, genitourinary tract, respiratory system, skin and immune system are Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans. In the past, there have been nosodes available for prohibiting diseases that occur due to these pathogens. However, it is inconvenient and also expensive for patients to administer different nosodes multiple times for each pathogen. There is a lack of nosodes which can be recommended and used in the prohibition of different diseases that occur due to multiple pathogens. Since nosodes only contain a specific pathogen, there is a need for multiple administrations of different nosodes to combat multi-pathogen infections. However, this may be expensive and the need for multiple administrations may also affect patient compliance
Therefore, there is felt a need to provide a homeopathic composition that mitigates the aforestated drawbacks.

OBJECTS
Some of the objects of the present disclosure, which at least one embodiment herein satisfies, are as follows:
It is an object of the present disclosure to ameliorate one or more problems of the prior art or to at least provide a useful alternative.
It is another object of the present disclosure to provide a homeopathic composition which can be effectively used against single or multiple pathogens as well as for diseases not associated with any specific pathogen.
It is yet another object of the present invention to provide a process for preparation of a homeopathic composition.
Other objects and advantages of the present disclosure will be more apparent from the following description, which is not intended to limit the scope of the present disclosure.

DETAILED DESCRIPTION
Embodiments, of the present disclosure, will now be described herein. Embodiments are provided so as to thoroughly and fully convey the scope of the present disclosure to the person skilled in the art. Numerous details are set forth, relating to specific components, and methods, to provide a complete understanding of embodiments of the present disclosure. It will be apparent to the person skilled in the art that the details provided in the embodiments should not be construed to limit the scope of the present disclosure. In some embodiments, well-known processes, well-known apparatus structures, and well-known techniques are not described in detail.
The terminology used, in the present disclosure, is only for the purpose of explaining a particular embodiment and such terminology shall not be considered to limit the scope of the present disclosure. As used in the present disclosure, the forms "a,” "an," and "the" may be intended to include the plural forms as well, unless the context clearly suggests otherwise. The terms "comprises," "comprising," “including,” and “having,” are open ended transitional phrases and therefore specify the presence of stated features, integers, steps, operations, elements, modules, units and/or components, but do not forbid the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. The particular order of steps disclosed in the method and process of the present disclosure is not to be construed as necessarily requiring their performance as described or illustrated. It is also to be understood that additional or alternative steps may be employed.
As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed elements.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
Nosode is a composition made from a dilute and potentized pathological tissue sample taken from blood, feces, mucus, pus or tissue of an infected or diseased organism or organism such as bacteria, virus or parasites and administered to a human to promote immunity against disease.
Five of the major pathogens which commonly affect the gastrointestinal tract, genitourinary tract, respiratory system, skin and immune system are Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans. These pathogens have the capacity to produce major and minor diseases of multiple organs and systems in animals and humans as follows:
Escherichia coli: Gastroenteritis, urinary tract infections, neonatal meningitis, hemorrhagic colitis, Crohn’s disease, bowel necrosis, hemolytic-uremic syndrome, peritonitis, mastitis, septicemia and Gram-negative pneumonia.
Salmonella typhi: Typhoid fever or Enteric Fever.
Klebsiella pneumoniae: Pneumonia, urinary tract infections, septicemia, meningitis, diarrhea and soft tissue infections.
Neisseria gonorrhoeae: Gonorrhoeae, urethritis, epididymitis, orchitis, cystitis, pelvic inflammatory disease, proctitis, prostatitis, pharyngitis, meningitis, endocarditis and tenosynovitis.
Candida albicans: Local and systemic infections in immunocompromised states involving mouth, genitals, urinary tract, asthma and small intestinal fungal overgrowth (SIFO).
Conventionally, individual nosodes have been used for treating diseases or disorders associated with Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans respectively. The nosodes target individual pathogens and different nosodes need to be administered in case of multi-organism infection. However, this is inconvenient and expensive for patients.
Therefore there is felt a need for a homeopathic composition that is effective against multiple pathogens and does not require multiple administrations.
The present disclosure envisages a polynosodic homeopathic composition that is effective against multiple pathogens, which can be recommended and used in the control of diseases that occur due to single or multiple pathogens as well as diseases not associated with a specific pathogen and which requires single administration for effective protection from such pathogens instead of multiple administrations of several different nosodes.
In an aspect of the present disclosure, there is provided a polynosodic homeopathic composition comprising a homogenized mixture of a potentized polynosode and a vehicle.
The polynosode is obtained from virulent strains of a plurality of pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans.
The virulent strain of Escherichia coli used is at least one selected from the group consisting of Escherichia coli ATCC 11775, Escherichia coli ATCC 25922, Escherichia coli ATCC 8739, Escherichia coli (ECECO-COMB) and Escherichia coli (ECCOMB).
The virulent strain of Salmonella typhi used is at least one selected from the group consisting of Salmonella enterica subsp. enterica serovar Typhimurium ATCC 51812, Salmonella enterica subsp. enterica serovar Typhimurium ATCC 13311, Salmonella Typhimurium (STCOMB) and Salmonella Typhimurium (STETCOMB).
The virulent strain of Klebsiella pneumoniae used is Klebsiella pneumoniae ATCC BAA-2146.
The virulent strain of Neisseria gonorrhoeae used is Neisseria gonorrhoeae ATCC 43069.
The virulent strain of Candida albicans used is at least one selected from the group consisting of Candida albicans ATCC 24433, Candida albicans ATCC 6790, Candida albicans ATCC 60193 and Candida albicans (CANACOMB).
The virulent strains of the pathogens were obtained from the United States of America.
In accordance with an embodiment of the present disclosure, the vehicle is at least one selected from the group consisting of alcohol, water and sachhrum lactose.
In accordance with an embodiment of the present disclosure, the ratio of the potentized polynosode to the vehicle is 1:9 for 1X potency and 1:99 for 1C potency or any other ratio of proportion wherein Unit ‘X’ refers to Decimal potency and unit ‘C’ refers to Centesimal potency.
In accordance with an embodiment of the present disclosure, the polynosodic homeopathic composition is used in the treatment of diseases or disorders associated with pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans.
In accordance with an embodiment of the present disclosure, the polynosodic homeopathic composition can be used in any combination of one or more pathogens, in conjunction with conventionally known medicines or as a stand-alone therapeutic agent.
The polynosodic homeopathic composition can be used for specific diseases or general indications. It may also be used as a prophylactic measure. The polynosodic homeopathic composition of the present disclosure also produces immunostimulatory and immunomodulatory effect. The polynosodic homeopathic composition may even be used for the treatment of diseases and disorders associated with multiple pathogens other than Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans as well as for those diseases not caused by any specific pathogen, for instance, migraine, chronic abdominal pain, chronic backaches, etc.
The polynosodic homeopathic composition of the present disclosure can be formulated for oral dosage or parenteral administration. The oral dosage forms include pills, tablets, drops and syrup.
Since the polynosodic homeopathic composition comprises a potentized polynosode, it can be used to treat diseases and disorders associated with single or multiple pathogens or the diseases not caused by any specific pathogen, in a single administration. Since there is no need for administration of multiple individual nosodes, the treatment is more economical for the patient and also increases patient compliance.
In another aspect of the present disclosure, there is provided a process for preparing a polynosodic homeopathic composition. The process comprises preparing a polynosode by isolating virulent strains of a plurality of pathogens selected from the group consisting of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans; cultivating the isolated virulent strains on a suitable growth medium to obtain cultured strains and triturating the cultured strains with a vehicle to obtain the polynosode, wherein the ratio of the cultured strains to the vehicle is in a predetermined range. The polynosode is potentized by serially diluting and succussing the polynosode in the vehicle to obtain a potentized polynosode having predetermined potency. The potentization step is iterated for a predetermined number of times to obtain a polynosodic homeopathic composition having a predetermined potency.
In accordance with an exemplary embodiment of the present disclosure, the suitable growth medium is selected from the group consisting of Eosin Methylene Blue and nutrient agar, Xylose Lysine Deoxycholate (XLD) and nutrient agar, MacConkey agar and nutrient agar, Thayer Martin agar and nutrient agar and Sabouraud dextrose agar.
In accordance with an exemplary embodiment of the present disclosure, the vehicle for the process is selected from the group consisting of alcohol, water and sachhrum lactose.
In accordance with an exemplary embodiment of the present disclosure, for the trituration step, the ratio of the cultured strains to the vehicle is in the range of 1: 99 to 50:50.
In accordance with an exemplary embodiment of the present disclosure, the vehicle used for the trituration step is sachhrum lactose.
The trituration step can be carried out for about 20 minutes such that it includes 6 minutes of grinding, 3 minutes of scraping and 1 minute of mixing wherein all three are repeated.
In accordance with an exemplary embodiment of the present disclosure, the potentized polynosode has potency in the range of 1C to 1 million C.
In accordance with an exemplary embodiment of the present disclosure, the vehicle used for the potentization step is selected from alcohol and water.
In accordance with an exemplary embodiment of the present disclosure, the potentization step is performed using an electro-mechanical potentizer.
In accordance with an exemplary embodiment of the present disclosure, the potency of the polynosodic homeopathic composition is in the range of 30C to 10,000C.
Typically, the safety of polynosodic homeopathic composition in various potencies can be established by the absence of any infective or toxic materials as well as the absence of microbial material. The laboratory based safety studies have demonstrated absence of any pathogenic material in the polynosode in the potencies such as 12C and above.
The foregoing description of the embodiments has been provided for purposes of illustration and not intended to limit the scope of the present disclosure. Individual components of a particular embodiment are generally not limited to that particular embodiment, but, are interchangeable. Such variations are not to be regarded as a departure from the present disclosure, and all such modifications are considered to be within the scope of the present disclosure.
The present disclosure is further described in light of the following experiments which are set forth for illustration purpose only and not to be construed for limiting the scope of the disclosure. The following experiments can be scaled up to industrial/commercial scale and the results obtained can be extrapolated to industrial scale.

EXPERIMENTAL DETAILS
Example 1:
Candida albicans ATCC 26790 virulent strain of Candida albicans was cultivated on Sabouraud dextrose agar medium to obtain cultured strains. 20 billion cells of the cultured strains were triturated with 36 gm of sachhrum lactose to obtain a nosode having 1X potency. The nosode was potentized by serially diluting and succussing the nosode in 200 mg of 6X + 10 ml of water and 10 ml of alcohol to obtain a potentized nosode having 4C potency. The potentization step was iterated 31 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 35C.
Example 2:
Candida albicans ATCC 24433 virulent strain of Candida albicans was cultivated on Sabouraud dextrose agar medium to obtain cultured strains. 20 billion cells of the cultured strains were triturated with 36 gm of sachhrum lactose to obtain a nosode having 1X potency. The nosode was potentized by serially diluting and succussing the nosode in 200 mg of 6X + 10 ml of water and 10 ml of alcohol to obtain a potentized nosode having 4C potency. The potentization step was iterated 96 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 100C.
Example 3:
Neisseria gonorrhoeae ATCC 43069 virulent strain of Neisseria gonorrhoeae was cultivated on Thayer Martin agar and nutrient agar medium to obtain cultured strains. 20 billion cells of the cultured strains were triturated with 35 gm of sachhrum lactose to obtain a nosode having 1X potency. The nosode was potentized by serially diluting and succussing the nosode in 200 mg of 6X + 10 ml of water and 10 ml of alcohol to obtain a potentized nosode having ¬¬¬4C potency. The potentization step was iterated 31 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 35C.
Example 4:
Escherichia coli ATCC 11775, Escherichia coli ATCC 25922 and Escherichia coli 9730 virulent strains of Escherichia coli were cultivated on Eosin Methylene Blue and nutrient agar medium to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 40 gm of sachhrum lactose to obtain a nosode having 1X potency. The nosode was potentized by serially diluting and succussing the nosode in 200 mg of 6X and 20 ml of 10% alcohol to obtain a potentized nosode having 4C potency. The potentization step was iterated 26 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 30C in 10% alcohol.
Example 5:
Salmonella enterica subsp. enterica serovar typhimurium ATCC 51812 and Salmonella enterica subsp. enterica serovar typhimurium ATCC 13311 virulent strains of Salmonella typhi were cultivated on Xylose Lysine Deoxycholate (XLD) and nutrient agar medium to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 40 gm of sachhrum lactose to obtain a nosode having 1X potency. The nosode was potentized by serially diluting and succussing the nosode in 200 mg of 6X and 20 ml of 10% alcohol to obtain a potentized nosode having ¬¬¬4C potency. The potentization step was iterated 26 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 30C in 10% alcohol.
Example 6:
Klebsiella pneumoniae ATCC BAA-2146 and Escherichia coli ATCC 11775 virulent strains of Klebsiella pneumoniae and Escherichia coli, respectively, were cultivated on MacConkey agar and nutrient agar medium and Eosin Methylene Blue and nutrient agar medium, respectively, to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 35 gm of sachhrum lactose to obtain a polynosode having 1X potency. The polynosode was potentized by serially diluting and succussing the polynosode in 20 ml of water to obtain a potentized polynosode having ¬¬¬4C potency. The potentization step was iterated 31 and 96 times, respectively, to obtain a polynosodic homeopathic composition; wherein the potency of the composition was Klebsiella pneumoniae 35C and Escherichia coli 100C.
Example 7:
Isolated virulent strains of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans, respectively, were cultivated on Eosin Methylene Blue and nutrient agar, Xylose Lysine Deoxycholate (XLD) and nutrient agar, MacConkey agar and nutrient agar, Thayer Martin agar and nutrient agar and Sabouraud dextrose agar medium to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 30 gms of sachhrum lactose to obtain a polynosode having 1X potency. The polynosode was potentized by serially diluting and succussing the polynosode in 20 ml water to obtain a potentized polynosode having 4C potency. The potentization step was iterated 26 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 30C.
Example 8:
Isolated virulent strains of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans, respectively, were cultivated on Eosin Methylene Blue and nutrient agar, Xylose Lysine Deoxycholate (XLD) and nutrient agar, MacConkey agar and nutrient agar, Thayer Martin agar and nutrient agar and Sabouraud dextrose agar medium to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 30 gms of sachhrum lactose to obtain a polynosode having 1X potency. The polynosode was potentized by serially diluting and succussing the polynosode in 20 ml water to obtain a potentized polynosode having 4C potency. The potentization step was iterated 46 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 50C.
Example 9:
Isolated virulent strains of Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans, respectively, were cultivated on Eosin Methylene Blue and nutrient agar, Xylose Lysine Deoxycholate (XLD) and nutrient agar, MacConkey agar and nutrient agar, Thayer Martin agar and nutrient agar and Sabouraud dextrose agar medium to obtain cultured strains. 20 billion cells of each of the cultured strains were triturated with 30 gms of sachhrum lactose to obtain a polynosode having 1X potency. The polynosode was potentized by serially diluting and succussing the polynosode in 20 ml water to obtain a potentized polynosode having 4C potency. The potentization step was iterated 96 times to obtain a polynosodic homeopathic composition; wherein the potency of the composition was 100C.

IN-VITRO STUDIES
The in-vitro efficacy of the polynosodic homeopathic composition was tested using the Minimum Inhibitory Concentration assay technique at Nair Hospital, Department of Pharmacology, Mumbai. The polynosodic homeopathic compositions, as formulated in Examples 1 to 9, were tested along with positive control, i.e., Antibiotics (Ciprofloxacin, Ofloxacin, Amoxicillin, Meropenam and Ceftriaxone), as illustrated in Table 1
TABLE 1
Treatment Escherichia coli Salmonella typhi Klebsiella pneumoniae Neisseria gonorrhoeae Candida albicans
Example 1 Inhibits - - - Inhibits
Example 2 - Partly Inhibits - - Inhibits
Example 3 - - Inhibits - Inhibits
Example 4 Inhibits - Inhibits - -
Example 5 - Partly Inhibits - - Inhibits
Example 6 - - Partly Inhibits - -
Example 7 - - - - Partly Inhibits
Example 8 - - - - Partly Inhibits
Example 9 - - - - -
Antibiotics (Ciprofloxacin, Ofloxacin, Amoxicillin, Meropenam and Ceftriaxone) Inhibits Inhibits Partly Inhibits Inhibits Inhibits

Therefore, it can be inferred from Table 1 that the polynosodic homeopathic composition of the present disclosure can be used effectively for the treatment of diseases or disorders associated with Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans. It must be noted that the polynosodic homeopathic compositions which do not display inhibitory activity against pathogens, may yet provide symptomatic relief for other conditions which are not associated with any specific pathogen. Lack of inhibitory activity against one or more pathogens does not render the polynosodic homeopathic composition ineffective.
Further, it can be inferred from Table 1 that the polynosodic homeopathic composition of the present disclosure displays inhibitory activity comparable to antibiotics like Ciprofloxacin, Ofloxacin, Amoxicillin, Meropenam and Ceftriaxone.

ANECDOTAL STUDIES
Anecdote 1: Mrs. SP, age 68, presented with repeated urinary infections affecting the bladder and urethra for over 2-3 years. These infections occurred once in about 4-6 weeks and would subside with one or two courses of antibiotics. She also had chronic abdominal pain which was usually unrelated to the urinary infection. She experienced frequent semi-solid motions showing the presence of mucus along with chronic leucorrhea and possibly some form of vaginitis. The skin in the groin region had developed a fungal infection, probably tenia cruris, causing intense itching. Anti-fungal medications were only effective superficially. She also suffered from chronic bronchitis and had a previous history of pneumonitis. In order to treat the above-mentioned infections she was regularly consuming antibiotics
Considering the multiple afflictions and infections related to the urinary tract, gastrointestinal tract, vagina, skin and respiratory tract, she was prescribed a polynosodic homeopathic composition of 30c potency, prepared in accordance with Example 7 of the present disclosure, to be taken twice a day for about three months. The frequency of various infections reduced significantly. After about subsequent six months of treatment, the need for a frequent course of antibiotics reduced considerably. Thus it can be seen that using the polynosodic homeopathic composition, prepared in accordance with Example 7, helped restore the immunity of the patient and resulted in a reduction in the frequency of infections as well as consumption of antibiotics.
Anecdote 2: Sri, a seven years old boy was brought with frequent diarrheas for about two years. The problems started after an episode of Typhoid fever, which was adequately treated by suitable antibiotics. He would have 3-4 semi-solid to watery stools almost daily, with dull aching pain in the abdomen. Sometimes the stools could be more frequent with more pain particularly if certain food such as spicy food or outside food was consumed. He was also having a frequent fungal infection (Oral Thrush) probably due to the frequent use of antibiotics for diarrhea. Sri also complained of episodes of bronchial wheezing and bronchitis requiring bronchodilators and occasional course of antibiotics. The child was prescribed the polynosodic homeopathic composition of 30c potency, prepared in accordance with Example 7 of the present disclosure, to be taken three times a day for about six weeks. He showed a definite improvement. His stools became more formed and less painful. He did not require any course of antibiotics since the treatment started. The polynosodic homeopathic composition was continued twice a day for the next two months. He reported continued improvement. However, he had an episode of Upper Respiratory Tract infection with tonsillitis, for which he was administered antibiotics by his pediatrician. His frequent, semi-solid stools almost stopped. The passing of mucus in the stools also stopped. His abdominal pain reduced significantly. Thus it can be seen that the polynosodic homeopathic composition, prepared in accordance with Example 7, helped minimize the residual effects of typhoid fever and helped in normalizing the motions of the child and the need for consumption of antibiotics and bronchodilators was eliminated.
Anecdote 3: Mr. PP, 87 years old gentleman presented with frequent urinary infections for three years persisting after surgery for Benign Enlargement of the Prostate (BEP). He also had a history of frequent prostatitis along with BEP. He was a chronic smoker in the past and also complained of chronic bronchitis since over fifty years, with every change in climate or even otherwise, at least once in two months, requiring house-hold medicines or occasional course of antibiotics from his family physician. His appetite was poor and he was constipated. He had chronic fungal infection on groins for many years, which would subside by suing anti-fungal power and medicines. Considering his recurring and chronic urinary tract infections clubbed with respiratory infections and fundal infection, he was prescribed polynosodic homeopathic composition of 30c potency, prepared in accordance with Example 7 of the present disclosure, to be taken twice a day for about 2 months. He improved to some extent. He was then prescribed the polynosodic homeopathic composition in 50c potency, prepared in accordance with Example 8 of the present disclosure, to be taken twice a day for the next 6 weeks. His urinary and chest infections improved. The fungal infection did not show much improvement. The composition was continued in 100c potency, prepared in accordance with Example 9 of the present disclosure, to be taken twice a day for the next three months. He showed more improvement with regards to urinary, respiratory and skin infections. His appetite improved and bowels go better. Of course, his infections did not disappear as it was very chronic and due to his old age, but he had improved significantly, and also the need for antibiotics reduced. Thus it can be seen that by administering higher potencies of the polynosodic homeopathic composition, the urinary, respiratory and skin infections showed marked improvement while also restoring the digestive system of the patient.
Thus from the anecdotal studies provided above it can be concluded that the polynosodic homeopathic composition of the present disclosure can be used for the treatment of diseases or disorders associated with Escherichia coli, Salmonella typhi, Klebsiella pneumoniae, Neisseria gonorrhoeae and Candida albicans and it minimizes or eliminates the need for consumption of antibiotics.

TECHNICAL ADVANCEMENTS
The present disclosure described herein above has several technical advantages including, but not limited to, the realization of a polynosodic homeopathic composition for effective prohibition of diseases that occur due to different pathogens as well as for the diseases which are not caused by a specific pathogen, in a single administration, thereby making it economical for the patient and increasing patient compliance.
The embodiments herein and the various features and advantageous details thereof are explained with reference to the non-limiting embodiments in the following description. Descriptions of well-known components and processing techniques are omitted so as to not unnecessarily obscure the embodiments herein. The examples used herein are intended merely to facilitate an understanding of ways in which the embodiments herein may be practiced and to further enable those of skill in the art to practice the embodiments herein. Accordingly, the examples should not be construed as limiting the scope of the embodiments herein.
The foregoing description of the specific embodiments so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.
The use of the expression “at least” or “at least one” suggests the use of one or more elements or ingredients or quantities, as the use may be in the embodiment of the invention to achieve one or more of the desired objects or results. While certain embodiments of the inventions have been described, these embodiments have been presented by way of example only, and are not intended to limit the scope of the inventions. Variations or modifications to the composition of this invention, within the scope of the invention, may occur to those skilled in the art upon reviewing the disclosure herein. Such variations or modifications are well within the spirit of this invention.
The terms first, second, third, etc., should not be construed to limit the scope of the present disclosure as the aforementioned terms may be only used to distinguish one element, component, region, layer or section from another component, region, layer or section. Terms such as first, second, third etc., when used herein do not imply a specific sequence or order unless clearly suggested by the present disclosure.
Any discussion of documents, acts, materials, devices, articles or the like that has been included in this specification is solely for the purpose of providing a context for the disclosure. It is not to be taken as an admission that any or all of these matters form a part of the prior art base or were common general knowledge in the field relevant to the disclosure as it existed anywhere before the priority date of this application.
The numerical values given for various physical parameters, dimensions, and quantities are only approximate values and it is envisaged that the values higher than the numerical value assigned to the physical parameters, dimensions and quantities fall within the scope of the invention unless there is a statement in the specification to the contrary.
While considerable emphasis has been placed herein on the specific features of the preferred embodiment, it will be appreciated that many additional features can be added and that many changes can be made in the preferred embodiment without departing from the principles of the disclosure. These and other changes in the preferred embodiment of the disclosure 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 disclosure and not as a limitation.

Documents

Application Documents

# Name Date
1 201921036906-FORM 18 [05-09-2023(online)].pdf 2023-09-05
1 201921036906-STATEMENT OF UNDERTAKING (FORM 3) [13-09-2019(online)].pdf 2019-09-13
2 201921036906-FORM-26 [08-01-2021(online)].pdf 2021-01-08
2 201921036906-PROOF OF RIGHT [13-09-2019(online)].pdf 2019-09-13
3 201921036906-COMPLETE SPECIFICATION [13-09-2019(online)].pdf 2019-09-13
3 201921036906-POWER OF AUTHORITY [13-09-2019(online)].pdf 2019-09-13
4 201921036906-DECLARATION OF INVENTORSHIP (FORM 5) [13-09-2019(online)].pdf 2019-09-13
4 201921036906-FORM 1 [13-09-2019(online)].pdf 2019-09-13
5 201921036906-DECLARATION OF INVENTORSHIP (FORM 5) [13-09-2019(online)].pdf 2019-09-13
5 201921036906-FORM 1 [13-09-2019(online)].pdf 2019-09-13
6 201921036906-COMPLETE SPECIFICATION [13-09-2019(online)].pdf 2019-09-13
6 201921036906-POWER OF AUTHORITY [13-09-2019(online)].pdf 2019-09-13
7 201921036906-FORM-26 [08-01-2021(online)].pdf 2021-01-08
7 201921036906-PROOF OF RIGHT [13-09-2019(online)].pdf 2019-09-13
8 201921036906-FORM 18 [05-09-2023(online)].pdf 2023-09-05
8 201921036906-STATEMENT OF UNDERTAKING (FORM 3) [13-09-2019(online)].pdf 2019-09-13