DESC:FIELD OF THE INVENTION
This present invention relates to polyherbal tablet in covid-19 positive patient for antiviral & anti-inflammatory response. The present disclosure relates with phytochemistry science, Tablet is developed by using 12 phytoconstituents combined in 5 blends. In particular, the present disclosure relates to the polyherbal composition comprising of Shilajit, Panax ginseng, Sea buckthorn, Tinospora cordifolia, Ashwagandha, Medicago sativa Linn. Curcuma longa Linn. Bacopa monnieri, Carica papaya, Milk thistle, Moringa, Punarnava to form tablet for antiviral & anti-inflammatory response. The present disclosure further relates to the method of preparing the said polyherbal mixture.

BACKGROUND OF THE INVENTION
Coronaviruses are enveloped positive sense RNA viruses ranging from 60 nm to 140 nm in diameter with spike-like projections on their surface giving them a crown-like an appearance under the electron microscope hence named coronavirus. Coronaviruses (CoVs), can infect animals as well as humans, causing respiratory, gastrointestinal, hepatic, and neurologic diseases. As the largest known RNA viruses, CoVs are further divided into four genera: alpha, beta, gamma and delta-coronavirus. Recently Omicron with multiple genome sequence started to spread throughout the world. The coronavirus genome is comprised of ~30000 nucleotides.
Medicinal plants and isolated phytochemicals can cover multiple therapeutic targets at the same time and lie in the fact that they are widely used in the treatment of various diseases, including viral diseases and related complications. Since infection with any of the viruses of the Coronaviridae family, including SARS-CoV-2, can cause severe damage to the pulmonary system, the plant-derived secondary metabolites can play a significant role in reducing these pulmonary complications. The phytochemicals with different molecular targets and signaling mechanisms, including reducing proinflammatory and oxidant mediators minimize lung injury. Therefore, protective effects on lung injury, along with other effects, including antiviral (especially anti-CoVs) effects, have attracted the attention of many researchers on the use of phytochemicals as potential strategies for discovering new anti-Cov agents regarding controlling related complications. Following are phytochemical and phytoconstituents used to formulate tablet by synergy blend for target action.
• Shilajit is a pale-brown to blackish-brown exudation from the layers of rocks in many mountain ranges of the world, especially the Himalayas and Hindukush ranges of the Indian subcontinent. Shilajit as an immunomodulator agent is studied in mice that are given either Shilajit extract or a placebo. It is found that the white blood cell activity is increased by Fulvic acid isolated part in shilagit. The observed activity increased as the dose of shilajit extract and time of exposure are increased
• Panax ginseng, also called Asian or Korean ginseng, has long been traditionally used to treat various diseases. The major active ingredients of are ginsenosides, which have shown therapeutic effects, including antioxidation, anti-inflammatory, vasorelaxation, antiallergic, antidiabetic, and anticancer. Panax extract has effect on human immunodeficiency virus type 1 (HIV-1)-infected patients administered highly active antiretroviral therapy, which analyzed the CD4 T-cell count, viral load, and resistance mutations
• Sea buckthorn (Hippophae rhamnoides L.) is in the focus of interest mainly for its positive effects on the health of both human and animal organisms. The sea buckthorn components most contributing to the immunomodulating effect include high amounts of soluble vitamin C, leucocyanidin, and catechin in the first place and then also isorhamnetin, quercetin, and quassin. These substances strengthen the immune system of the organism and increase resistance to illnesses
• Tinospora cordifolia commonly named “Guduchi” in Sanskrit designated as Rasayana drug recommended to enhance general body resistance, promote longevity and as an antistress and adaptogen. crude extracts with a polyclonal B cell mitogen, G1-4A on binding to macrophages have been reported to enhance immune response in mice by inducing secretion of IL-1, together with activation of macrophages
• Ashwagandha attains the special name because its root smells like horse a (“Ashwa”) and believe to provide power like a horse when consumed. Withania somnifera show an immuno-potentiating and myeloprotective effects know roots by enhancing the levels of interferon (IFN)-?, interleukin (IL)-2 and granulocyte-macrophage colony-stimulating factor in normal and cyclophosphamide-treated mice
• Medicago sativa Linn. (Leguminosae), commonly known as the “father of all foods”, is a perennial herbaceous leguminous plant species that originated in Asia. In an in vitro experiment, polysaccharides isolated from M. sativa exhibited immunopotentiating activity by increasing mouse lymphocyte uptake of [3H] thymidine
• Curcuma longa Linn. is commonly known as Haldi, Turmeric or Indian saffron belongs to the family Zingiberaceae. Curcumin reserved the acetylation of Tat protein of HIV significantly by p300 related with invasion of HIV-1 multiplication. Curcumin by targeting the acetyltransferase proteins of p300/CREB binding protein can be a potent compound for combinatorial HIV therapeutics
• Bacopa monnieri (family: Scrophulariaceae) is a reputed drug of Ayurveda. It is used in traditional medicine to treat various nervous disorders and for promoting memory and intellect. Bacopa monnieri shows an anticancer effect which is possibly due to the inhibition of DNA replication in cancer cell lines
• Carica papaya (known in Ayurveda as Erand-karkati) is used in the treatment of various ailments such as asthma, ulcers, eczema, diabetes, helminth infections, and fever. In vitro and in vivo studies have shown that papaya extracts and papaya-associated phytochemicals possess anti-inflammatory and immunomodulatory properties
• Milk thistle (silymarin) has been used since the time of ancient to treat a range of liver and gallbladder disorders. Recent studies have also documented the antiviral activities of silymarin and its derivatives against several viruses, including the flaviviruses (hepatitis C virus and dengue virus), togaviruses (Chikungunya virus and Mayaro virus), influenza virus, human immunodeficiency virus, and hepatitis B virus
• Moringa- Contains full of vitamins and minerals that play a vital role as electrolytes during fatigue. It is proven in different symptoms like poor vitality, stress, body ache, and weakness.
• Punarnava- Punarnava plays an important role in the detoxification of toxins from the liver and kidney. It is historically proven for kidney function, anti-inflammatory response, and in body aches.

US7250181B2 discloses Polyherbal compositions and methods for treating viral infections, discloses The present invention relates to pharmaceutical or veterinary or nutritional compositions of polyherbal extracts useful as anti-viral or immune-supporting agents. Particularly, the present invention of polyherbal composition comprises of extracts of Withania somnifera, Mangifera indica and purified Shilajit. This cost effective immune-supporting agent is ideal for use during the maintenance phase of the treatment, following an initial viral load reduction phase in which it is used as an adjuvant to conventional anti-viral drug therapy. The anti-viral and immune-supporting composition of this invention can perhaps be the sole basis of treatment where affordability is an issue. Additionally, this composition is used for the treatment, prevention or management of immune-supporting system in primates in need, especially humans.

CA2864816A1 discloses herbal formulation for the modulation of immune system of hiv infected patients and a process of preparation thereof., discloses novel herbal formulation for the modulation of immune system of hiv infected patients and a process of preparation thereof, comprising (i) preparing a hydromethanolic extract of at least one plant selected from Hippophae rhamnoides, Convolvulus pluricaulis, Withania somnifera, Ocimum sanctum, and Cynodon dactylon at 80-90°C, maintaining the pH of the solution between 6-7 (ii) separating the active compound chromatographically and (iii) subjecting the active compounds to the step of molecular characterization. Further, according to this invention there is provided a process for the preparation of novel plant based Ayurvedic formulation as claimed in claim-I comprising of preparing aqueous adding methanolic extract of Hippophae rhamnoides (Badriphal, Fruits), Convolvulus pluricaulis (Shankhapushpi, whole plant), Withania somnifera (Ashwagandha; Root), Cynodon dactylon (Durva, Whole plant) and Ocimum sanctum (Tulsi - Leaves), by using aqueous and methanol (50:50) at 80°-90°C temperature and maintaining pH of solution between 6-7, separating the active compound chromatographically of each plant material (extract) by using TLC, HPLC and HPTLC separation of the molecules of plant extract by using GCMS, LCMS and 2D NiVlR.

International Journal of Medical Science and Clinical Research Studies (Vol. 2 No. 2 (2022): Volume 02 Issue 02 February 2022) A Randomized, Open Labeled Clinical Survey To Evaluate The Anti-Viral, Anti-Inflammatory and Immune Modulator Role of Polyherbal Combinations in Viral Infections of Respiratory Tract (Naram, S., Mahajan, D., & Parekh, H. (2022) discloses Cough is the common reflex produced for upper respiratory tract infections (URTI), however, a cough can also be a symptom of other hidden conditions like asthma or other lung diseases. The immune modulation with Ayurvedic formulations as possible therapeutic measures is the need of time. Ancient Indian medicinal system of Ayurveda has a wide scope for treating many diseases by the theory of Rasayana. Rasayana in other terms are called as preparations from plant or herbal sources which have immunomodulatory properties. As this is a Pilot study each participant is supplied with the Swaswin D Vyro (Virofight) 625 mg two tablets twice a day, Swaswin Asthaloc 600 mg two tablets twice a day, Syrup Swaswin Kaphano 5 ml twice a day after food with lukewarm water at each visit.The results were assessed with a scale developed by Ayushakti Ayurveda Pvt Ltd. The scale is general, and self-administered. It consists of seven symptoms in the respiratory tract. Individual scale symptom responses are assigned a score between 0 (none) to 10 (Extreme). Total assessment of the result was done on the basis of relief from symptoms of the disease.This combination is helpful for viral infection of healthy individuals as well as in asthma-like chronic conditions of the respiratory tract, including patients with comorbid conditions. This combination acts as an antiviral, anti-inflammatory, antispasmodic, immune modulatory and antitussive.

Pharmaceuticals (Volume 15 Issue 2) Antioxidant–Anti-Inflammatory Evaluation of a Polyherbal Formula (Grigore, Alice, et al.) discloses Most disease—both acute and chronic—results from inflammation, and reactive oxygen species (ROS) are considered some of the strongest stimuli of inflammation. Many studies reported the traditional use of herbal species for treating inflammation, especially when ROS are involved. The present study aims to demonstrate the antioxidant–anti-inflammatory effects of a patented preparation based on Populus nigra and Rosmarinus officinalis extracts and to highlight its applicative potential; the formula was characterized by HPTLC and HPLC and in-vitro studies were conducted on TNF-a-stimulated HUVECs. The antioxidant activity of the formula was determined by DPPH assay and the phosphomolybdenum method; to assess in-vivo anti-inflammatory activity, a rat paw edema model was used; the formula contains high amounts of polyphenols. It exhibited scavenging activity of 50–85% at 1–10 mg/mL, it inhibited nitrite production and ICAM-1 expression in TNF-a-stimulated endothelial cell cultures dose-dependently, at a maximum of 58.7% at the maximum dose administered and exerted an obvious anti-inflammatory effect in vivo, settling early and decreasing at 180 min; a new herbal bioactive product was presented with promising therapeutic potential that can be an adjunct to conventional therapies for diseases based on oxidative stress and inflammation.

International journal of pharmaceutical sciences and research (Vol. 4, Issue 3) formulation and evaluation of polyherbal gel for anti - inflammatory activity (Dixit, Gouri, et al.) discloses three medicinal plants Cynodon dactylon (L.) Pers, Cassia tora Linn. and Cassia alata Linn having significant antiinflammatory potential were selected to be formulated as polyherbal gels. The gels were prepared using the dried methanolic extract of Cassia tora Linn, Cassia alata Linn and Cynodon dactylon (L.) Pers. Polyherbal gel formulations were evaluated for its pH, appearance and homogeneity, viscosity, spreadability and skin irritation studies. Assessment of Antiinflammatory activity was done by carrageenan induced rat paw edema and formalin- induced rat paw edema. Individual and polyherbal gel of Cassia alata Linn,Cassia tora Linn. and Cynodon dactylon (L.) Pers were found to possess anti-inflammatory effect in acute and chronic models. Polyherbal gel also showed synergistic effect as compared to individual gels which can be useful for the treatment of local inflammation.

OBJECTIVE OF INVENTION
According to Ayush guidelines some of the herbs like Ashwagandha, Giloy, Yastimadhu, and Pipli play a vital role as an adjuvant treatment in covid-19 patients. We innovate tablet with 12 synergy phytoconstituents combination-based tablet proven for Anti-SARS Cov-2 study as per Department of Biotechnology lab. Human clinical trials show as an adjuvant almost 40% fast recovery found without any mortality.
Objective of invention is still SARS-Cov-2 genome spread with modification and still covid treatment protocol not fixed yet due to lacking of study and causality of virus. Hence, we invent symptomatic treatment with multiple actions like Anti-viral, Anti-inflammatory in a single dosage form. The Science behind tablet formulation is a unique granulating blend with an active causality target for overall improvement in symptoms of viral diseases like covid-19 and antiviral support also. The Efficacy and efficiency of individual phytoconstituents improve by synergy blend which is developed by unique granulation.

SUMMARY OF THE INVENTION
The present invention relates to polyherbal tablet in covid-19 positive patient for antiviral & anti-inflammatory response.
In particular, the present disclosure relates with phytochemistry science, Tablet is developed by using 12 phytoconstituents combined in 5 blends to form tablet for antiviral & anti-inflammatory response.
In particular, the present disclosure relates to the polyherbal composition comprising of;
a. Shilajit extract, Panax ginseng extract, Ashwagandha extract having 10-20 % concentration combined to form blend 1.
b. Giloy extract, Sea buckthorn extract, Papaya extract having 6-20% concentration combined to form blend 2.
c. Curcumin, Brahmi extract having 4-8% concentration combined to form blend 3.
d. Moringa extract, Alfalfa extract having 3-5% concentration combined to form blend 4.
e. Milk thistle extract, Punarnava extract having 1-5% concentration combined to form blend 5.
The present disclosure further relates to the method of preparing the said polyherbal mixture.
a. Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.
b. Standard extract synergy mixture without process mixed for 45-60 min.
c. Modified synergy blend after process for antiviral & anti-inflammatory response.
d. Dry all blend of Phytoconstituents in tray dryer or fluidized bed dryer for 45-90 min at 55-60 0C.
e. Pulverized it in sieve number 80-100.
Then Standard extract and modified blend are evaluated for flow properties, in-vitro solubility, and in-vitro release uniformity.

DETAILED DESCRIPTION OF THE INVENTION
Detailed Description of the Invention While this specification concludes with claims particularly pointing out and distinctly claiming that, which is regarded as the invention, it is anticipated that the invention can be more readily understood through reading the following detailed description of the invention and study of the included examples.

The following is a detailed description of embodiments of the present disclosure. The embodiments are in such detail as to clearly communicate the disclosure. However, the amount of detail offered is not intended to limit the anticipated variations of embodiments; on the contrary, the intention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the present disclosure as defined by the appended claims.

Unless the context requires otherwise, throughout the specification which follow, the word “comprise” and variations thereof, such as, “comprises” and “comprising” are to be construed in an open, inclusive sense that is as “including, but not limited to.”

Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment. Thus, the appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment. Furthermore, the particular features, structures, or characteristics may be combined in any suitable manner in one or more embodiments.

The headings and abstract of the invention provided herein are for convenience only and do not interpret the scope or meaning of the embodiments.
Various terms are used herein. To the extent a term used in a claim is not defined below, it should be given the broadest definition persons in the pertinent art have given that term as reflected in printed publications and issued patents at the time of.
Natural products and their derivatives have potential actions in the treatment of viral infections. Chinese Traditional Medicine (CTM) has suggested great clinical experiences, effective and applicable herbal formulas on the inhibition and treatment of respiratory diseases, and in COVID 19 as well. India traditionally uses natural remedies for the management of viral diseases, pneumonia, and various respiratory symptoms. Even in phytopharmaceutical patent work and clinical trials are running on with single or synergy form of phytochemicals such as curcumin, gingerol, withanolides, piperine and many more. in viral disease and in covid-19 also fatigue is the main symptoms hence antibiotic dose is not safe for all because of low WBC and Platelet count and hence multiple effect precise dosage form developed with synergy phytoconstituents blend with antiviral, anti-inflammatory and symptomatic relief in different viral disease.
Table 1. Formulation of polyherbal blend
Sr no Ingredients Concentration Blend
1 Shilagit extract 10-20 % Blend -1
2 Panax ginseng extract 10-20 %
3 Ashwagandha extract 10-20 %
4 Giloy extract 10-20 % Blend-2
5 Sea buckthorn extract 6-12 %
6 Papaya extract 6-9 %
7 Curcumin 5-8 % Blend-3
8 Brahmi extract 4-8 %
9 Moringa extract 3-5% Blend-4
10 Alfalfa extract 3-5%
11 Milk thistle extract 2-5% Blend-5
12 Punarnava extract 1-3 %

EXAMPLES
1. Process of Blend-1
Sr no Ingredients Concentration Granulating agent
1 Shilagit extract 10-20 % 0.2-0.5 % of Okra powder
2 Panax ginseng extract 10-20 %
3 Ashwagandha extract 10-20 %

Step-1: Mixed all ingredients according to concentration for 30-60 min.
Step-2: Dissolve Okra powder with mentioned quantity in distilled water and keep it for 1 hours.
Step-3: Step-2 Granulating solution slowly adds in to step-1 mixed blend.
Step-4: Mixture of Step -2 and Step-3 keep it for drying for 45-90 min at 55-60 0C in a tray dryer.
Step-5: Dried granules passed through a sieve 80-100.

2. Process of Blend-2
Sr no Ingredients Concentration Granulating agent
4 Giloy extract 10-20 % 0.1-0.4 % of Boswellic acid
5 Sea buckthorn extract 6-12 %
6 Papaya extract 6-9 %

Step-1: Mixed all ingredients according to concentration for 30-60 min.
Step-2: Dissolve Boswellic acid with mentioned quantity in distilled water and keep it for 1 hours for loading on the mechanical stirrer.
Step-3: Step-2 Granulating solution slowly adds in to step-1 mixed blend.
Step-4: Mixture of Step -2 and Step-3 keep it drying for 45-90 min at 55-600 C in a tray dryer.
Step-5: Dried granules passed through sieve 80-100.

3. Process of Blend-3
Sr no Ingredients Concentration Granulating agent
7 Curcumin 5-8 % 0.1-0.3% of Brahmi saponin +Glycerin
8 Brahmi extract 4-8 %

Step-1: Mixed all ingredient according to concentration for 30-60 min.
Step-2: Dissolve Brahmi saponin with mentioned quantity in distilled water diluted with Glycerin (Brahmi: Glycerin ratio-10:1) and keep it for 1 hours for loading on mechanical stirrer.
Step-3: Step-2 Granulating solution slowly add in to step-1 mixed blend.
Step-4: Mixture of Step -2 and Step-3 keep it for drying for 45-90 min at 55-600 C in tray dryer.
Step-5: Dried granules passed through sieve 80-100.

4. Process of Blend-4
Sr no Ingredients Concentration Granulating agent
9 Moringa extract 3-5% 0.1-0.2 % HPMC in Distilled water
10 Alfalfa extract 3-5%

Step-1: Mixed all ingredients according to concentration for 30-60 min.
Step-2: Dissolved HPMC in distilled water and mixed it for 1 hour a mechanical stirrer. Filter it and then add HPMC Aqueous solution as a granulating solution in the step-1 mixed blend.
Step-4: Above Mixture keeps it for drying for 45-90 min at 55-600 C in a tray dryer.
Step-5: Dried granules passed through a sieve 80-100.

5. Process of Blend-5
Sr no Ingredients Concentration Granulating agent
11 Milk thistle extract 2-5% 0.1-0.2 % of Kalmegh saponin
12 Punarnava extract 1-3 %

Step-1: Mixed all ingredients according to concentration for 30-60 min.
Step-2: Add The Kalmegh saponin mentioned amount in distilled water as a granulating solution and then slowly added in the step-1 mixed blend.
Step-4: Above Mixture keeps it for drying for 45-60 min at 55-600 C in tray dryer.
Step-5: Dried granules passed through sieve-100.

The Final process for tablet compression
Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.

EVALUATION PARAMETERS
Table 2. Pre and Post Comparatively evaluation of Synergy blend of Tablet
Blend Std. Carr’s Index Modified Carr’s Index Std. Solubility Modified solubility Std. % Release uniformity Modified % Release uniformity
Blend-1 28-30 12-14 3-5 mg/ml 15-20 mg/ml R2= 0.781 R2= 0.980
Blend-2 29-30 13-16 4-5 mg/ml 20-24 mg/ml R2= 0.822 R2= 0.993
Blend-3 27-29 14-15 0.2-0.4 mg/ml 0.8-1.2 mg/ml R2= 0.796 R2= 0.989
Blend-4 26-28 16-18 1-3 mg/ml 9-12 mg/ml R2= 0.865 R2= 0.999
Blend-5 28-30 14-16 4-6 mg/ml 10-14 mg/ml R2= 0.903 R2= 0.994

Standard extract synergy mixture without process mixed for 45-60 min. Modified synergy blend after process out as per the described method. Then Standard extract and modified blend are evaluated for flow properties, in-vitro solubility, and in-vitro release uniformity. Standard extract synergy mixture contains poor micro, eritics properties, poor solubility and dose dumping found during release, which means no uniformity is found in the release profile. The Converted modified blend is evaluated for same and it is found significant improvement in the overall mentioned evaluation parameters. Stability and Physical characterization report conclude that all blend is stable and no interaction is found during the process.

DEMOGRAPHIC CHARACTERISTICS
Table 3. Demographic Characteristics
Parameters STD Group (N=30) Test Group (N=30)
@Age (years)
Mean
SD
Range
41.60
10.80
23.00 – 61.00 years
38.90
10.75
22.00 – 64.00 years
#Sex (%)
Male
Female
24 (80.0)
06 (20.0)
19 (63.3)
11 (36.7)
@ By Student t test, NS = Not Significant, # By Chi Square Test

PRIMARY OUTCOMES: PROFILE OF PCR NEGATIVITY IN BOTH THE GROUPS

Table 4. Primary Outcomes
Duration in days STD Group (N = 30)
No. % Test group (N = 30)
No. %
4 12 40.0 18 60.0
7 18 60.0 23 83.3
10 23 83.3 *30 100.0
By Fisher exact test, * P = 0.01, Significant
COMPARISON OF MEAN CHANGES IN Ig G LEVEL BETWEEN THE GROUPS
Table 5. Comparison Of Mean Changes
Duration in Days Mean Ig G Level ( ? SD)

STD Group (N=14) Test Group (N=13)
Baseline 1179.43 ? 199.55 1183.1 ? 290.9
10 1266.44 ? 206.91 1178.0 ? 326.0
Mean Change (Baseline – Day 10) 86.71 ? 134.28 -5.15 ? 120.9
P value * P= 0.03 P = 0.88(NS)
P value (Study vs Test) P =0.07(NS)
By Student t Test NS = Not Significant, * Significant
COMPARISON OF MEAN CHANGES IN Ig M LEVEL BETWEEN THE GROUPS
Table 6. Comparison Of Mean Changes
Duration in Days Mean Ig M Level ( ? SD)

STD Group (N=14) Test Group (N=13)
Baseline 97.94 ? 44.61 97.93 ? 33.41
10 128.96 ? 46.92 104.20 ? 27.99
Mean Change (Baseline – Day 10) 31.02 ? 26.90 6.27 ? 12.28
P Value *P = 0.008 P = 0.08 (NS)
P value (Study vs Test)
*P = 0.005
By Student t Test NS = Not Significant, * Significant
COMPARISON OF MEAN CHANGES IN CRP BETWEEN THE GROUPS
Table 7. Comparison of Mean Changes In Crp Between The Groups
Duration in Days Mean CRP ( ? SD)

STD Group (N=30) Test Group (N=30)
Baseline 33.62 ? 52.00 29.87 ? 52.53
10 20.00 ? 42.08 12.77 ? 16.81
Mean Change (Baseline – Day 10) -13.62 ? 67.08 -17.10 ? 46.29
P value P = 0.27(NS) *P = 0.05
P value (Study vs Test) P = 0.81(NS)

By Student t Test NS = Not Significant
COMPARISON OF MEAN CHANGES IN LDH BETWEEN THE GROUPS
Table 8. Comparison of Mean Changes In Ldh Between The Groups
Duration in Days Mean LDH ( ? SD)

STD Group (N=30) Test Group (N=30)
Baseline 640.40 ? 983.35 451.77 ? 278.96
10 463.68 ? 364.57 297.67 ? 120.66
Mean Change (Baseline – Day 10) -176.72 ? 963.19 -154.10 ? 299.58
P value P = 0.32(NS) *P = 0.008
P value (Study vs Test) P = 0.90(NS)
By Student t Test NS = Not Significant, * Significant
SECONDARY AND SAFETY OUTCOMES
By Student t Test Not Significant
COMPARISON OF MEAN SpO2 BETWEEN THE GROUPS
Table 9. Comparison of Mean Spo2 Between The Groups

Duration in Days Mean SpO2 ( ? SD)

N STD Group N Test Group
Baseline 30 95.60 ? 3.63 30 95.90 ? 3.01
1 30 96.17 ? 2.94 30 96.00 ? 2.95
2 30 96.90 ? 1.47 30 97.00 ? 1.84
3 30 97.00 ? 1.66 30 96.73 ? 1.96
4 30 96.33 ? 2.93 30 96.53 ? 1.93
5 18 97.39 ? 1.04 12 97.67 ? 0.98
6 18 96.56 ? 2.28 12 97.58 ? 0.79
7 18 96.56 ? 1.65 12 97.83 ? 0.58
8 12 96.25 ? 1.66 07 97.71 ? 0.95
9 12 96.50 ? 1.68 07 97.71 ? 0.95
10 11 96.55 ? 1.75 07 97.86 ? 1.07
By Student t Test Not Significant
OUTCOME
In the present invention, the Standard extract synergy mixture is modified by a unique innovative process to improve its poor characteristic and to maintain uniformity, and compatibility in a dosage form. Std. The mixture of Phytoconstituent blend without process contains poor micromeritics properties, poor solubility, and dose dumping found during release, which means no uniformity found in the release profile. Improvised modified blend evaluated for same and it is found significant improvement in overall mentioned evaluation parameters. The Stability and Physical characterization report conclude that all blend is stable and no interaction is found during the process.
Standard extract synergy mixture contains poor micro, eritics properties, poor solubility and dose dumping found during release, which means no uniformity is found in the release profile. The Converted modified blend is evaluated for same and it is found significant improvement in the overall mentioned evaluation parameters. Stability and Physical characterization report conclude that all blend is stable and no interaction is found during the process.
In the present invention, ACT-12 formulations developed using advanced phytochemistry, are compared for their safety and clinical efficacy along with the standard of care in Hospitalized COVID-19 patients. The interpretation of the study parameters obtained is expressed as follows. 60.0% of cases from the Test Group i.e. ACT-12 along with the standard of care showed PCR Negativity at Day 4 compared to 40% from the standard of care group. 83.3% of cases from the Test Group i.e. ACT-12 along with the standard of care showed PCR Negativity at day 7 compared to 60% from the standard of care group. No Patient continued to remain positive after the 10th day in the Test Group i.e. ACT-12 along with the standard of care, whereas in the standard care group, 7 patients (23.3 %) are positive after 10 days. Test group i.e. ACT-12 along with the standard of care showed substantial improvement in SpO2. The average respiratory rate showed improvement after the addition of ACT-12 in the standard of care and also subjects in the same group are relieved of cough, shortness of breath, fever, and Body ache, faster than subjects on the only standard of care. It can be inferred that ACT-12 contributed to improving disease-specific symptoms and the Overall quality of life of the subject. ACT-12 demonstrated anti-inflammatory activity by lowering CRP and LDH levels thereby reducing the risk of lung tissue injury & lung fibrosis. Thrombocytopenia is associated with an increased risk of severe disease and mortality in patients with COVID-19; it is found that there is an improvement in Thrombocytopenia in a group where ACT-12 is added in a standard of care which can reduce the risk of hospitalization. The IgG and IgM immunoglobulin levels are raised in subjects treated with ACT-12 along with the standard of care which can be related to improved antibody functionality and thereby the immunomodulatory activity offered. In subjects treated with ACT-12 along with the standard of care, it is found improvement in fluctuated hematological parameters. No significant post-treatment change in any of the biochemical investigations like liver function, kidney function, and lipid profiles. No fluctuation is found in respiratory rate and blood pressure. This indicates the safety of ACT-12 in the management of COVID 19. No mortality has been observed in the TEST group (ACT-12 along with the standard of care) throughout the study and this demonstrates safety of the treatment. No Patient is positive after the 10th day in the same group. There is consensus that in severe COVID-19 infections, an exacerbated pulmonary and systemic inflammatory response occurs, with increased serum levels of inflammatory markers such as C-reactive protein (CRP) and lactic dehydrogenase (LDH), all of which may result in cytokine storms similar to SARS and MERS. In the present clinical study, there is reduction in parameters like CRP and LDH with quick recovery time which may lead to better management of the cytokine storm due to ACT-12 addition in a standard of care.
,CLAIMS:1. A polyherbal blend of tablet composition is developed by using 12 phytoconstituents combined in 5 blends comprising of;
a. Shilajit extract, Panax ginseng extract, Ashwagandha extract having 10-20 % concentration combined to form blend 1.
b. Giloy extract, Sea buckthorn extract, Papaya extract having 6-20% concentration combined to form blend 2.
c. Curcumin, Brahmi extract having 4-8% concentration combined to form blend 3.
d. Moringa extract, Alfalfa extract having 3-5% concentration combined to form blend 4.
e. Milk thistle extract, Punarnava extract having 1-5% concentration combined to form blend 5.
2. A method of preparation of polyherbal blend of tablet composition comprises of;
a. Mixed all blend uniformly, add talcum as a lubricant (1-2%) & compressed into a tablet without any diluent, binder, or chemicals.
b. Standard extract synergy mixture without process mixed for 45-60 min.
c. Modified synergy blend after process for antiviral & anti-inflammatory response.
d. Dry all blend of Phytoconstituents in tray dryer or fluidized bed dryer for 45-90 min at 55-60 0C.
e. Pulverized it in sieve number 80-100.

3. The polyherbal composition as claimed in claim 1, wherein the said polyherbal composition in the form tablet evaluated for flow properties, in-vitro solubility, and in-vitro release uniformity.
4. The polyherbal composition as claimed in claim 1, wherein the said polyherbal composition in the form tablet for antiviral & anti-inflammatory response.