DESC:TECHNICAL FIELD:
The present disclosure relates to the development of a formulation to treat wound infection and heal the wound. More particularly, the present disclosure relates to composition(s) or formulation(s) comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain is an efficacious strategy to manage wound infection and wound healing and a process to prepare said formulation. For example, present composition or formulation can be used in case of wound after surgery such as cancer surgery. The composition or formulation as and when used enhances tissue rebuilding in post-operative wound healing, wound healing after cancer surgery, wound healing after general surgery, any wound healing process and reduces wound infections. Suitable additives, pharmaceutically acceptable excipients and carriers can be present in said composition or formulation.

BACKGROUND:
It is known that, owing to multiple reasons, treatment of wound infection and its process of healing after surgery (such as cancer surgery) remains a daunting challenge. The global estimates of surgical site infection (SSI) have varied from 0.5% to 15%. Studies in India have shown consistently higher rates of SSI ranging from 23% to 38%. An alteration in nutritional intake and thereby in the overall immunity in patients after surgery also contributes to it and makes patients more susceptible to postoperative infections and malnutrition.
Surgical Site infections are associated with prolonged stay in hospitals, delayed recovery, reduced quality of life, higher morbidity and mortality and higher cost during prognosis. Malnutrition may also occur due to alteration in nutritional intake resulting in decreased wound tensile strength and increased infection rate, resulting in delaying in recovery. According to WHO Surgical Site Infection prevention guidelines, providing the right nutrition can have an impact on wound healing.
Wound healing, substitution of destroyed or damaged tissue by newly produced one, can classically be divided into four steps: haemostasis, inflammation, cell proliferation and tissue maturation. With each successive phase in the normal sequence of wound healing, the immune system orchestrates a wide variety of processes. Different immune cells have been shown to peak in number and activity at different times during the healing cascade, thus helping distinguish the different stages of the process. As the ardent votaries in the laboratories as well as clinics have witnessed in past decades, enormous efforts have been directed to develop beneficial techniques for achieving speedy recovery minimizing the scar, ensuring function preservation. To avert infection and stimulate a proper healing process, the classical approach for wound management still remains as topical administration of antibacterial or colloidal agents. The healing process may be dismayed by both internal and external factors, viz., necrotic tissue, pathogen contamination, entrapment of non-native materials, comorbidities such as diabetes mellitus, etc., causing a delay in each phase of recovery. Often times, skirmishes brake out when wound closure gets affected by colonization of an invading microbial agent. It turns out that, due to synergistic bacterial development pattern, chronic wound infections are polymicrobial. On the other hand, acute wounds are generally associated with a diminished microbial load, scab formation and immune cells infiltration in the initial phase, while healing is correlated with re-epithelialization, angiogenesis and fibroblast migration.
Although chronic wounds are marked by a local depletion of growth factors, topical administration without a proper dispensing vector does not influence re-epithelialization. Nonetheless, Rh-PDGF (recombinant human platelet-derived growth factor) has been approved for treating wounds. Outcome of multiple clinical trials revealed that enhanced TGFß-3 isoform (transforming growth factor ß-3) resulted in a proper dermal restoration with higher tensile strength, without an increase in healing time or excessive scarring. Expression of MMP-2 (matrix metalloproteinase-2), VEGF (vascular endothelial growth factor) and MCP-1 (membrane cofactor protein-1) in keratinocytes, endothelial cells and fibroblasts has also been proven to boost angiogenesis and mitigate inflammation. As ratiocinated with the advancement of global research, currently available wound healing therapies generally fail to provide an adequate clinical outcome, either structurally such as wound re-epithelialization, control of fluid loss, or functionally such as histological features that determine elasticity, durability, sensitivity, etc.
Many facets of wound healing under redox control require a delicate balance between oxidative stress (caused by accumulation of reactive oxygen species (ROS)) and antioxidants. While the normal physiology of wound healing depends on low levels of ROS and oxidative stress, an overexposure to oxidative stress leads to impaired wound healing. Stated differently, while production of ROS is essential to initiate wound repair, excessive amount of ROS generation is deleterious in wound healing. Increasing oxidative stress, associated with lipid peroxidation, protein modification and DNA damage has been shown to impair wound healing processes via increased cell apoptosis and senescence. Antioxidants are tested to help control wound oxidative stress and thereby accelerate wound healing (1, 2).
The components of the compositions/formulations for Liss WH, an Oral Nutritional Supplement (ONS) of the present invention containing various immuno-nutrients with potent probiotic strain act synergistically with acceptable pharmaceutically excipients and such composition/formulations reduce wound infection and heals wound in the patients with enhanced efficacy. For example, present composition or formulation can be used in case of wound after surgery such as cancer surgery (3-6).

SUMMARY:

The present invention relates to the development of a formulation to treat wound infection and heal the wound. More particularly, the present disclosure relates to composition(s) or formulation(s) comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain is an efficacious strategy to manage wound infection and wound healing and a process to prepare said formulation. For example, present composition or formulation can be used in case of wound after surgery such as cancer surgery. The composition or formulation as and when used enhances tissue rebuilding in post-operative wound healing, wound healing after cancer surgery, wound healing after general surgery, any wound healing process and reduces wound infections. Suitable additives, pharmaceutically acceptable excipients and carriers can be present in said composition or formulation.

OBJECTIVES:
Accordingly, an object of the present invention is to provide new synergistic composition(s) or formulation comprising a nutritional supplement product which will help in the process of reducing wound infection and wound healing in the patients. Non-limiting examples are wound healing in patients after surgery or wound healing in patients after cancer surgery.
Accordingly, an object of the present invention is to provide new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain which will help in the process of reducing wound infection and wound healing in the patients.
Yet another objective of the present disclosure is to develop a nutritional supplementation which will help in the process of wound healing after cancer surgery. Also, another objective is to show how this product aids in improving the nutritional status in the patients recovering from surgery, for example cancer surgery.
Accordingly, an object of the present invention is to provide new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain and pharmaceutically acceptable excipients and carriers wherein the pharmaceutical composition is useful in the process of reducing wound infection and wound healing in the patients, such as wound healing after surgery, or wound healing after cancer surgery.

DETAILED DESCRIPTION:
For the purpose of promoting an understanding of the principles of the invention, reference will now be made to the embodiments and specific language will be used to describe the same. It will nevertheless be understood that no limitation of the scope of the invention is thereby intended, such alterations and further modifications in the illustrated system, and such further applications of the principles of the invention as illustrated therein being contemplated as would normally occur to one skilled in the art to which the invention relates.
It will be understood by those skilled in the art that the foregoing general description and the following detailed description are explanatory of the invention and are not intended to be restrictive thereof.
Unless otherwise defined, all terms, and especially any technical and/or scientific terms, used herein may be taken to have the same meaning as commonly understood by one having an ordinary skill in the art.
Reference throughout this specification to “an aspect”, “another aspect” or similar language means that a particular feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrase “in an embodiment”, “in another embodiment” and similar language throughout this specification may, but do not necessarily, all refer to the same embodiment.
The terms "comprises", "comprising", or any other variations thereof, are intended to cover a non-exclusive inclusion, such that a process or method that comprises a list of steps does not include only those steps but may include other steps not expressly listed or inherent to such process or method. Similarly, one or more devices or sub-systems or elements or structures or components proceeded by "comprises... a" does not, without more constraints, preclude the existence of other devices or other sub-systems or other elements or other structures or other components or additional devices or additional sub-systems or additional elements or additional structures or additional components.

In an embodiment of the present invention, certain nutrients like amino acids (glutamine etc.), vitamins (A, C, E etc.), antioxidants (beta-carotene, coenzyme Q10 etc.), fatty acids (Omeag-3. medium chain triglycerides etc.), trace elements, minerals etc. are helpful in wound management. The effects of microbial wound colonization on healing process are particularly important and therefore, a higher level of attention and research are required to evaluate the microbial effects on wound-healing ability, potential new therapeutic agents that can regulate the cross-talk between microflora, pathogens and the innate immune response, and lead to wound healing acceleration. There is a major impact of commensal microorganisms, beneficial bacteria, on multiple physiological processes including protection against pathogenic invasion and infection as well as immunomodulatory effects in tissue repair. Of many, Lactic acid bacteria (LAB) and bifidobacteria are some of species that improve host welfare and are referred to as probiotics.
ß-carotene is a precursor (inactive form) to vitamin A, producing the latter via action of ß-carotene 15,15'-monooxygenase. In the molecular chain between the two cyclohexyl rings, ß-carotene cleaves either symmetrically or asymmetrically. Symmetric cleavage with the aforementioned enzyme requires an antioxidant such as a-tocopherol. It turns out that ß-carotene, a polyene dietary carotenoid, acts as an immune modulator with a potential to quench singlet oxygen, scavenge free radicals (ROS) at lower partial oxygen pressures. Vitamin A (general term for retinoids) plays an important role in all stages of wound healing. It is known for its ability to stimulate epithelial growth, fibroblasts, granulation tissue, angiogenesis, collagen synthesis, epithelialization, and fibroplasia. Local (topical) and systemic supplementation with vitamin A has been proven to increase dermal collagen deposition. Vitamin E has long been known to possess antioxidant properties and several animal studies have evaluated the role of orally or parenterally administered vitamin E in wound healing. On the molecular level, vitamin C is needed for the hydroxylation of the amino acids proline and lysine. These hydroxylated products contribute to the stabilization of the triple helix structure of collagen. It seems safe to say that correction of vitamin C deficiency is crucial for wound healing, but it remains to be proven that supplementation, whether at a low or high dose, can further improve healing. Next, coenzyme Q10 (CoQ10) or ubiquinone is known for its key role in mitochondrial bioenergetics as electron and proton carrier; later studies demonstrated its presence in other cellular membranes and in blood plasma, and extensively investigated its antioxidant role. It has healing effects on wounded tissues by decreasing oxidative stress and improved mitochondrial efficiency. A previous study demonstrated that oral administration of CoQ10 induced synthesis of collagen on injured skin tissue and had positive effects on cutaneous healing in mice. Importantly, branched chain amino acids (BCAAs) are fuels for skeletal muscle, especially during periods of stress. They are initially metabolized extrahepatically and play a regulatory role in skeletal muscle and visceral protein metabolism by promoting protein synthesis and decreasing muscle proteolysis. BCAA infusions have also been found to maintain plasma and intramuscular glutamine levels by enhancing glutamine synthesis and release from the muscle. Glutamine is central to the regulation of nitrogen turnover by the BCAA. It is the main source of energy for immune cells. It provides energy and DNA bases in rapidly proliferating cells. Hence, an enhanced intake of the same can improve the healing of surgical wounds. Alongside, beneficial gut bacteria enhance intestinal absorption of nutrients important for wound healing. In this regard, a probiotic blend (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus fermentum and Bifidobacterium bifidum) is of immense importance for management of wound. They have multifarious functions namely, collagen synthesis, H2O2 production, enhanced absorption of dietary vitamin D and E, induction of TNFa, IFN-?, IL-10, increase in neutrophil infiltration, anti-microbial activity, etc.
In accordance with an embodiment of the present disclosure, an Oral Nutritional Supplement (ONS) formulation is provided.
An object of the present invention is to provide new synergistic composition(s) or formulation comprising a nutritional supplement product which will help in the process of reducing wound infection and wound healing in the patients. Non-limiting examples are wound healing in patients after surgery or wound healing in patients after cancer surgery.
Accordingly, an object of the present invention is to provide new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain which will help in the process of reducing wound infection and wound healing in the patients.
Yet another objective of the present disclosure is to develop a nutritional supplementation which will help in the process of wound healing after cancer surgery. Also, another objective is to show how this product aids in improving the nutritional status in the patients recovering from surgery, for example cancer surgery.
Accordingly, an object of the present invention is to provide new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) containing various immuno-nutrients with potent probiotic strain and pharmaceutically acceptable excipients and carriers wherein the pharmaceutical composition is useful in the process of reducing wound infection and wound healing in the patients, such as wound healing after surgery, or wound healing after cancer surgery.

The present disclosure shows that with each successive phase in the normal sequence of wound healing, the immune system orchestrates a wide variety of processes. Different immune cells have been shown to peak in number and activity at different times during the healing cascade, thus helping distinguish the different stages of wound healing. The present composition or formulation enables the faster rate of wound healing as well as to improve the nutritional intake in the patients after cancer surgery.
In one of the embodiment of the present disclosure, new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) improve the nutritional intake in the patients after surgery. In another embodiment, new synergistic composition(s) or formulation comprising Liss WH, an Oral Nutritional Supplement (ONS) improve the nutritional intake in the patients after cancer surgery.
In yet another embodiment of the present disclosure, the Oral Nutritional Supplement (ONS) formulation is augmented with probiotic blend and natural antioxidants.
In accordance with another embodiment of the present disclosure, the probiotic blend comprises Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus fermentum and Bifidobacterium bifidum.
In yet another embodiment of the present disclosure, the probiotic blend has multifarious functions namely, collagen synthesis, H2O2 production, enhanced absorption of dietary vitamin D and E, induction of TNFa, IFN-?, IL-10, increase in neutrophil infiltration, anti-microbial activity, etc.
In accordance with another embodiment of the present disclosure, the probiotic blend enhances would healing in diabetic patients.
In yet another embodiment of the present disclosure, the Oral Nutritional Supplement (ONS) formulation is enriched with natural antioxidants and immuno-nutrients.
In accordance with another embodiment of the present disclosure, the natural antioxidants and immuno-nutrients include ß-carotene, coenzyme Q10, mixed tocopherols, etc.
In yet another embodiment of the present disclosure, the natural antioxidants and immuno-nutrients ingredients help in the prevention of infections in the surgical wounds, thus speeding up the recovery.
In accordance with another embodiment of the present disclosure, the Oral Nutritional Supplement (ONS) formulation is a powder blend.
In yet another embodiment of the present disclosure, other ingredients of the Oral Nutritional Supplement (ONS) formulation are whey protein peptide, glutamine peptides, collagen peptides, MCT, maltodextrin, inulin, vitamins, sucralose & permitted flavours.
In accordance with another embodiment of the present disclosure, Oral Nutritional Supplement (ONS) formulation is for use in wound management after surgery, in general. In accordance with another embodiment of the present disclosure, Oral Nutritional Supplement (ONS) formulation is for use in wound management after cancer surgery, in particular.
To manage wound as well as to improve the nutritional status in the patients after surgery such as cancer surgery, the product LISS WH is augmented with probiotic blend (Lactobacillus acidophilus, Lactobacillus casei, Lactobacillus fermentum and Bifidobacterium bifidum) which has multifarious functions namely, collagen synthesis, H2O2 production, enhanced absorption of dietary vitamin D and E, induction of TNFa, IFN-?, IL-10, increase in neutrophil infiltration, anti-microbial activity, etc. It is also enriched with natural antioxidants and immuno-nutrients such as ß-carotene, coenzyme Q10 and mixed tocopherols which help in the prevention of infections in the surgical wounds, thus speeding up the recovery in cancer surgery. The osmolarity range (280 to 300 mOsmol /Litre) is suitable for enteral tube feeding and better nutrient absorption. This serves the purpose as the post- operative wound healing product.
In yet another embodiment, new synergistic composition(s) or formulation(s) comprising the Oral Nutritional Supplement (ONS) may be in form of dry powder, liquid, syrup or any other form as required by patients having advanced cancers.
In yet another embodiment of the present invention, new synergistic composition(s) or formulation(s) comprising the Oral Nutritional Supplement (ONS) may include other additives including surfactants, preservatives, viscosity modifiers, and emulsion stabilizers, as per requirements.
In yet another embodiment of the present invention, new synergistic composition(s) or formulation(s) comprising the Oral Nutritional Supplement (ONS) may include other additives to modify the color or aroma of the compositions or formulations described herein.
In yet another embodiment of the present invention, the composition or formulation for Oral Nutritional Supplement for Wound Healing (Liss WH) comprising:
a) Immuno-nutrients (60-90 wt%); and
b) Probiotic strain. (10-40 wt.%)

In accordance with another embodiment of the present disclosure, the composition or formulation, further comprising natural antioxidants in the range of 20-40 wt%.

In yet another embodiment of the present invention, the composition or formulation, further comprising whey protein peptide, glutmaine peptides, collagen peptides, MCT, maltodextrin, inulin, vitamins, sucralose permitted flavours in the range of 20-50 wt%.

In accordance with another embodiment of the present disclosure, the composition or formulation, comprising:
Total Fat (5% RDA) : 1.5 gm
Medium Chain Triglycerides : 0.5 gm
Dietary Fiber (5% RDA) : 1.5 gm
Total Protein (17% RDA) : 10 gm
Vitamin A (Retinol Acetate) (100% RDA) : 600 mcg
Vitamin E (Mixed Tocopherols) (100% RDA) : 10 mg
Vitamin C (L-Ascorbic Acid) (100% RDA) : 40 mg
Glutamine Peptides : 1000 mg
Beta Carotene (100% RDA) : 4800 mcg
Coenzyme Q10 : 10 mg
Collagen Peptides : 500 mg
L-Glutamine : 1000 mg
Branched Chain amino acids : 1000 mg
(Leucin: Isoleucine:Valine ) in 2:1:1 ratio
Total Carbohydrates (Less than 5% RDA) : 7.5 gm
Total Calories (Less than 5% RDA) : 83.5 Kcal
Probiotic Blend : 10 Billion CFU.

In yet another embodiment of the present invention, the composition or formulation, Probiotic Blend comprising lactobacillus acidophilus, lactobacillus casei, lactobacillus fermentum, Bifidobacterium bifidum.
In accordance with another embodiment of the present disclosure, the natural antioxidants and immuno-nutrients in the composition or formulation comprises ß-carotene, coenzyme Q10 and mixed tocopherols.

In accordance with another embodiment of the present disclosure, Percent Daily Allowance is based on a 2,200 Calorie diet and per serving: 20 gm of the composition.

In yet another embodiment of the present invention, one serving of the composition or formulation is 20 gm taken with 150 ml water.

In accordance with another embodiment of the present disclosure, composition or formulation is having flavors selected from the group comprising Coco-caramel, French Vanilla, Rich milk Chocolate, Butterscotch, Pineapple, Orange, Lime, Condensed Cream flavours.

In yet another embodiment of the present invention, the composition or formulation as and when used enhances tissue rebuilding in post-operative wound healing, wound healing after cancer surgery, wound healing after general surgery, any wound healing process and reduces wound infections.
In accordance with another embodiment of the present disclosure, the composition or formulation has osmolarity range 280 to 300 mOsmol /Litre, which is suitable for enteral tube feeding.

EXAMPLES:
The present invention illustrated with the help of following examples, which are not intended to limit the scope of the invention and any such modification therein falls within the scope of this invention. It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are intended to provide further explanation of the subject matter. Those skilled in the art will appreciate that many modifications may be made in the invention without changing the essence of the invention.

Example 1:
Composition or Formula 1:
Immuno-nutrients in the range of 60 to 90 weight%;
Probiotic strain in the range of 10 to 40 weight%.

Example 2:
Composition or Formula 2:
Immuno-nutrients in the range of 60 to 90 weight %;
Probiotic strain in the range of 10 to 40 weight %.
Natural antioxidants in the range of 20 to 40 weight%.

Example 3:
Composition or Formulation 3:
• Immuno-nutrients in the range of 60 to 90 weight %;
• Probiotic strain in the range of 10 to 40 weight %;
• Natural antioxidants in a range of 20 to 40 weight %;
• whey protein peptide,
• glutmaine peptides,
• collagen peptides,
• MCT,
• maltodextrin,
• inulin,
• vitamins,
• sucralose
• permitted flavours
Whey protein peptide, glutmaine peptides, collagen peptides, MCT, maltodextrin, inulin, vitamins, sucralose, and permitted flavours are present in the range of 20 to 50 weight %.

Example 4:
Composition or Formulation 4:
Total Fat (5% RDA) : 1.5 gm
Medium Chain Triglycerides : 0.5 gm
Dietary Fiber (5% RDA) : 1.5 gm
Total Protein (17% RDA) : 10 gm
Vitamin A (Retinol Acetate) (100% RDA) : 600 mcg
Vitamin E (Mixed Tocopherols) (100% RDA) : 10 mg
Vitamin C (L-Ascorbic Acid) (100% RDA) : 40 mg
Glutamine Peptides : 1000 mg
Beta Carotene (100% RDA) : 4800 mcg
Coenzyme Q10 : 10 mg
Collagen Peptides : 500 mg
L-Glutamine : 1000 mg
Branched Chain amino acids : 1000 mg
(Leucin: Isoleucine:Valine ) in 2:1:1 ratio
Total Carbohydrates (Less than 5% RDA) : 7.5 gm
Total Calories (Less than 5% RDA) : 83.5 Kcal
Probiotic Blend : 10 Billion CFU
(lactobacillus acidophilus, lactobacillus casei, lactobacillus fermentum, Bifidobacterium bifidum)

* Percent Daily Allowance are based on a 2,200 Calorie diet.
Per serving: 20 gm of the composition

In one of the embodiment of the present disclosure, the composition or formulation is packed in 200 gm jar and it may vary as per requirements. In yet another embodiment, there are 10 servings per pack. In another embodiment present composition or formulation is packed in a suitable jar having more than 10 servings per pack, if required. In one of the embodiment, one serving has (1 scoop) is 20 gm taken with 150 ml water.

In yet another embodiment, the composition or formulation is having various flavors, non-limiting examples are Coco-caramel or French Vanilla or Rich milk Chocolate.

Storage:
In one of the embodiment, compositions or formulations of the present invention for Oral Nutritional Supplement is packed in suitable bottles or jars or other suitable packets for storage. The shelf life of the compositions or formulations of the present invention for Oral Nutritional Supplement is at least 24 months from the date of manufacture, when stored at ambient conditions. The package or the bottle or jar or storage container or other various storage means containing present composition or formulation should be stored at ambient conditions, in a clean, dry place and away from direct sunlight.

Example 5

Evidences from Case Studies with Liss WH:
Esperer Onco Nutrition has come up with an innovative nutritional supplements (Liss WH) that help cancer patients to obtain a speedy recovery of the wounds post-surgery thereby improving prognosis and Quality of Life (QoL). Below we are providing case studies of 8 volunteers during post-marketing surveillance (PMS) in Indo-American Hospital, Hyderabad which assessed the safety and wound healing efficacy of the aforementioned product to accelerate the wound recovery cancer patients.
Table 1 provides the general description of the patients, with tumor site, treatment, safety of nutritional intervention Liss-WH.
Table 2 summarizes would healing parameters and few biochemical parameters one week post-surgery. It is evident from our data that significant proliferation and tissue remodelling had already commenced within a week of Liss WH intervention. No adverse effects were reported by the volunteers. Further studies are ongoing to provide more mechanistic insights into the process which will come in the public domain in near future. All recorded biochemical parameters will also be furnished for better understanding of the entire prognosis. We fervently envisage that, with the co-operation of medical fraternity, Liss WH will create a remarkable difference in the QoL of the patients undergoing cancer surgery providing a post-operative speedy recovery.

Please find below Tables 1 and 2 (see next page):
Patient name Age Weight/Height/Sex Site of the Tumor Type of surgery Done Side effects of the treatment Nutritional Intervention Liss WH Dose Diet Adverse Effect
Patient 1 33 85 kg/ 165 cm/ Female Thyroid Total Thyroidectomy Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patient 2 48 60 kg /160 cm/ Female Ovarian tumor Radical hysterectomy + BSO Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patient 3 46 65 kg/ 153 cm/ Female Breast Rt mastectomy Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patient 4 47 75 kg/ 160 cm/ Female Thigh Malignant excision Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patint 5 57 66 kg/160 cm/ Female Rt breast Mastectomy+ SLNB Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patient 6 37 71 kg / 150 cm/Male Colon NACRT + Sigmoid colectomy Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None
Patient 7 61 88 kg /170 cm/ male Ascending colon Palliative care Mucositis and Dysphagia Liss-WH + Es-Invigour 40 gm/ day Liquid to soft diet, oral fluid None
Patient 8 47 61 kg / 162 cm/ Female RT breast Mastectomy + SLNB Mucositis and Dysphagia Liss-WH 40 gm/ day Liquid to soft diet, oral fluid None

Table 1: General description of the patients, with tumor site, treatment, safety of nutritional intervention Liss-WH

Patient Name Diagnosis Treatment types WOUND HEALING PARAMETER POST SURGERY (1 WEEK) BIOCHEMICAL PARAMETERS POST SURGERY (1 WEEK)
Colour of the wound Bleeding Inflammation Foul smell Proliferation Tissue Repair Hb (g/dL) WBC (cells/mm3) Neutrophils (%) Platelets (Lakhs/mm3)
Patient 1
Ca thyroid Surgery Red NO Redness, Pain and Swelling NO Pink coloured tissue Remodelling 13.8 10990 62% 3.2
Patient 2
Mucinous adenocarcinoma of ovary post Neoadjuvant chemotherapy Surgery and chemotherapy Red NO Redness and Pain NO Pink coloured tissue Remodelling 9.5 8500 55% 1.5
Patient 3
Ca Lt breast Surgery Red Yes Redness and Pain NO Pink coloured tissue Remodelling 12 7000 57% 2
Patient 4
Malignant melanoma of Rt thigh Surgery and Chemotherapy Red NO Redness NO Pink coloured tissue Remodelling 12 5500 50% 1.2
Patient 5
Ca RT breast Surgery Red NO Redness and pain NO Pink coloured tissue Remodelling 10.9 8490 56% 3.3
Patient 6
Rectosigmoid Colon Surgery and Chemotherapy Red Yes Redness and pain NO Pink coloured tissue Remodelling 10 4500 47% 2
Patient 7
Ca Ascending colon peritoneal Surgery and Chemotherapy Red NO Painful NO Pink coloured tissue Remodelling 8.2 10500 45% 1.1
Patient 8
Ca Rt breast Surgery Red No Inflammation NO Proliferation Remodelling 11.9 6490 46% 3.3
Table 2: Would healing parameters and biochemical parameters one week post-surgery

ADVANTAGES:

The following are the technical advantages of the invention:
• Composition(s) or formulation(s) for Oral Nutritional Supplement for Wound Healing (Liss WH) contains all the required nutrients for wound healing by enhancing the tissue rebuilding. Non-limiting examples are Post-Operative wound healing, wound healing after cancer surgery.
• It also contains natural super antioxidants such as ß-carotene and coenzyme Q10 & mixed tocopherols which help in the prevention of infections in the surgical wounds, thus speeding up the recovery.
• It is powered by probiotic blend which is clinically proven to enhance would healing in diabetic patients.
• It is a gluten and lactose free product.
• It has osmolarity range of 280 to 300 mOsmol /Litre, which is suitable for enteral tube feeding.

While the invention has been described and illustrated with reference to certain particular embodiments thereof, those skilled in the art will appreciate that various adaptations, changes, modifications, substitutions, deletions, or additions of procedures and protocols may be made without departing from the spirit and scope of the invention. For example, effective dosages other than the particular dosages as set forth herein above may be applicable as a consequence of variations in responsiveness of the mammal being treated for any of the indications with the compounds of the invention indicated above. The specific pharmacological responses observed may vary according to and depending upon the particular active compounds selected or whether there are present pharmaceutical carriers, as well as the type of formulation and mode of administration employed, and such expected variations or differences in the res tills arc contemplated in accordance with the objects and practices of the present invention. It is intended, therefore, that the invention be defined by the scope of the claims which follow and that such claims be interpreted as broadly as is reasonable.

While specific language has been used to describe the present subject matter, any limitations arising on account thereto, are not intended. As would be apparent to a person in the art, various working modifications may be made to the method in order to implement the inventive concept as taught herein.

References:
1. Cano Sanchez M, Lancel S, Boulanger E, Neviere R. Targeting Oxidative Stress and Mitochondrial Dysfunction in the Treatment of Impaired Wound Healing: A Systematic Review. Antioxidants (Basel). 2018 Jul 24;7(8):98. doi: 10.3390/antiox7080098.
2. Fitzmaurice SD, Sivamani RK, Isseroff RR. Antioxidant therapies for wound healing: a clinical guide to currently commercially available products. Skin Pharmacol Physiol. 2011;24(3):113-26. doi: 10.1159/000322643.
3. Zinder R, Cooley R, Vlad LG, Molnar JA. Vitamin A and Wound Healing. Nutr Clin Pract. 2019 Dec;34(6):839-849. doi: 10.1002/ncp.10420.
4. Ellinger S. Micronutrients, Arginine, and Glutamine: does supplementation provide an efficient tool for prevention and treatment of different kinds of wounds? Adv Wound Care (New Rochelle). 2014 Nov 1;3(11):691-707. doi: 10.1089/wound.2013.0482.
5. Yoneda T, Tomofuji T, Kawabata Y, Ekuni D, Azuma T, Kataoka K, Kunitomo M, Morita M. Application of coenzyme Q10 for accelerating soft tissue wound healing after tooth extraction in rats. Nutrients. 2014 Dec 10;6(12):5756-69. doi: 10.3390/nu6125756.
6. Lukic J, Chen V, Strahinic I, Begovic J, Lev-Tov H, Davis SC, Tomic-Canic M, Pastar I. Probiotics or pro-healers: the role of beneficial bacteria in tissue repair. Wound Repair Regen. 2017 Nov;25(6):912-922. doi: 10.1111/wrr.12607. ,CLAIMS:We Claim:
1. Composition or formulation for Oral Nutritional Supplement for Wound Healing (Liss WH) comprising:
a) Immuno-nutrients in the range of 60 to 90 weight %; and
b) Probiotic strain in the range of 10 to 40 weight %.

2. The composition or formulation as claimed in claim 1, further comprising natural antioxidants in the range of 20 to 40 weight %.

3. The composition or formulation as claimed in preceding claims, further comprising whey protein peptide, glutmaine peptides, collagen peptides, MCT, maltodextrin, inulin, vitamins, sucralose permitted flavours in the range of 20 to 50 weight %.

4. The composition or formulation as claimed in preceding claims, comprising:
Total Fat (5% RDA) : 1.5 gm
Medium Chain Triglycerides : 0.5 gm
Dietary Fiber (5% RDA) : 1.5 gm
Total Protein (17% RDA) : 10 gm
Vitamin A (Retinol Acetate) (100% RDA) : 600 mcg
Vitamin E (Mixed Tocopherols) (100% RDA) : 10 mg
Vitamin C (L-Ascorbic Acid) (100% RDA) : 40 mg
Glutamine Peptides : 1000 mg
Beta Carotene (100% RDA) : 4800 mcg
Coenzyme Q10 : 10 mg
Collagen Peptides : 500 mg
L-Glutamine : 1000 mg
Branched Chain amino acids : 1000 mg
(Leucin: Isoleucine:Valine ) in 2:1:1 ratio
Total Carbohydrates (Less than 5% RDA) : 7.5 gm
Total Calories (Less than 5% RDA) : 83.5 Kcal
Probiotic Blend : 10 Billion CFU.
5. The composition or formulation as claimed in preceding claims, wherein Probiotic Blend comprises lactobacillus acidophilus, lactobacillus casei, lactobacillus fermentum, Bifidobacterium bifidum.

6. The composition or formulation as claimed in preceding claims, wherein the natural antioxidants and immuno-nutrients comprises ß-carotene, coenzyme Q10 and mixed tocopherols.

7. The composition or formulation as claimed in preceding claims, wherein Percent Daily Allowance is based on a 2,200 Calorie diet and per serving: 20 gm of the composition.

8. The composition or formulation as claimed in claims 1 to 7, wherein one serving is 20 gm taken with 150 ml water.

9. The composition or formulation as claimed in claims 1 to 8, wherein the composition or formulation is having flavors selected from the group comprising Coco-caramel, French Vanilla, Rich milk Chocolate, Butterscotch, Pineapple, Orange, Lime, Condensed Cream flavours.

10. The composition or formulation as claimed in claims 1 to 9, wherein the composition as and when used enhances tissue rebuilding in post-operative wound healing, wound healing after cancer surgery, wound healing after general surgery, any wound healing process and reduces wound infections.

11. The composition or formulation as claimed in claims 1 to 9, wherein it has osmolarity range 280 to 300 mOsmol /Litre, which is suitable for enteral tube feeding.