DESC:FIELD OF THE INVENTION
The present invention relates to the field of viral infections. More specifically, the present invention relates to a herbal composition and preparation of the same for the management of coronavirus infections particularly COVID-19.

BACKGROUND OF THE INVENTION
Coronaviruses (CoV) belongs to the Coronaviridiae family that causes deadly diseases in humans or animals. These viruses are enveloped and have single stranded positive-sense large RNA genome. Severe Acute Respiratory Syndrome-Coronavirus-2 (SARS CoV-2) causes deadly pandemic coronavirus disease-2019 (COVID-19) in humans. The most common symptoms are fever, tiredness and dry cough. Some individuals also develop aches and pains, nasal congestion, runny nose, sore throat, or diarrhoea. It was reported that traditional remedies may alleviate the symptoms of COVID-19. Ayurveda is the world’s oldest medical system that can manage any disease without side effects. Ayurveda being the science of life, propagates the gifts of nature in maintaining healthy and happy living.
In the past, herbal medicine has played an important role in controlling infectious diseases. Clinical evidence from a range of studies of herbal medicine in the treatment of SARS coronavirus (SARS-CoV) has shown significant results, and supported the idea that herbal medicine has a beneficial effect in the treatment and prevention of epidemic diseases. While there is no medicine for COVID-19 as of now, it will be good to take preventive measures which boost immunity in these times.
Medicinal plants are considered as rich resources of ingredients which can be used in drug development of herbal or synthetic drugs. Apart from that, these plants play a critical role in the development of human cultures around the whole world. Current estimated mortality of COVID 19 for overall infected population is 0.25–3.0% whereas it increases to >14% among elderly (over 80 years), 10% in associated Cardiovascular Diseases (CVD) and 7% in associated diabetes. In 5% cases, intensive care is required, the disease progression is gradual and requires about 9-10 days to progress from symptoms of Upper Respiratory Tract Infection (URTI) to Acute Respiratory Distress Syndrome (ARDS). ARDS often is followed by un-correctable hypotensive shock, multi-organ failure and eventually death. China's experience of pandemic has built the evidences that co-morbidity such as hypertension, diabetes, coronary heart diseases and cerebrovascular disease act as risk factor with increased risk of mortality. There are many benefits of herbal medicine such as they are easier to obtain than prescribed medicine, stabilizes hormones and metabolism, natural healing, strength in immune system, fewer side effects.
WO2021179881A1 discloses the application of herbal composition in preparation of medicine for preventing and treating coronavirus complicated with lung injury. In this, the intervention effect of the herbal medicine composition on the novel coronavirus (SARS-CoV-2) is screened, and a clinical experiment result shows that the herbal medicine composition has a good effect of inhibiting lung injury and lung fibrosis caused by the novel coronavirus (SARS-CoV-2). The composition consists of astragalus, red peony and psoralen which has good inhibitory effect on the novel coronavirus (SARS-CoV-2) caused lung injury and pulmonary fibrosis.
WO2021203614A1 discloses about the pharmaceutical composition for treatment of coronavirus diseases and its preparation method and application. In this, the pharmaceutical composition contains water or alcohol extracts of ephedra, bitter almond, raw gypsum, coix seed, atractylodes, patchouli, polygonum cuspidatum, verbena, reed root, lepidium seed, pummelo peel, and sweet wormwood as the first Chinese herbal medicine while the second Chinese herbal medicine consists of water or alcohol extract of licorice.
US20050215494A1 discloses about the Baicalin and its derivatives as a treatment for SARS coronavirus infection or other infections. The Baicalin which is a naturally occurring compound is extracted and purified from the Chinese medicinal plant Scutellaria baicalensis Georgi that exhibits potent antiviral activity against members of the order Nidovirales of the family Coronaviradae that infects humans and other animals; in particular, SARS viruses in humans (“hSARS virus”).
Ang et al. J. Clin. Med. 2020, 9, 1583; (doi:10.3390/jcm9051583) discloses about herbal medicine for the treatment of coronavirus disease 2019 (COVID-19). It relates to evaluation of the effectiveness and adverse events of herbal medicines for the treatment of COVID-19. The results showed the significant effects of the combined therapy of herbal medicine with Western medicine as well as revealed the potential role of herbal medicine in treating COCID-19.
Ahmad et al. Front. Pharmacol., 02 March 2021 discloses about Indian medicinal plants and formulations and their potential against COVID-19. It relates to the AYUSH recommended formulations and their ingredients, routinely used medicinal plants and formulations by Indian population as well as other promising Indian medicinal plants, which can be tested against COVID-19.
There are some risk factors that make people susceptible. People with older age, presence of co-morbidities such as diabetes, hypertension and cardiovascular disease anorexia and presentation without fever are more susceptible. Reduced peripheral capillary oxygen saturation (SpO2) below 90% is also a risk indicator in apparently mild cases. Most pharmaceutical and herbal providers are trying to repurpose old flu and lung health formulas for Covid-19. However, Covid-19 has a multifaceted presentation and therefore, the present invention focuses on a multifaceted solution for the management of Covid-19 during this unprecedented time. Therefore, there is a need of a therapeutic herbal composition that focuses on a multifaceted solution for treating Covid-19 during this unprecedented time.

OBJECT OF THE INVENTION
The main object of the present invention is to provide a herbal composition for viral infections.
Another object of the present invention is to assess the clinical efficacy of the herbal composition compared to standard of care for the treatment of mild to moderate COVID-19.
Still another object of the present invention is to provide a method for preparing the herbal composition for the management of Covid-19.
Yet another object of the present invention is to provide a herbal composition and a method of preparation thereof with ten prong multifaceted approach for the management of Covid-19.

SUMMARY OF THE INVENTION
The present invention relates to a composition for the management of viral infections. More particularly, the present invention provides a herbal composition and method for the preparation of said composition for the management of COVID-19 with ten prong multifaceted approach.
In an embodiment, the present invention provides a herbal composition comprising of component A and component B. Component A is a combination of phytochemicals, amino acids, vitamins and minerals. The component B is a combination of polyherbal mixture of Andrographis panicullata, Phylanthus niruri, Glycirhizza glabra, Ocimum sanctum, Tinsopsora cordiflolia, Inula racemose, Alpinia galangal, Vitis vinifera, Curcuma longa, Terminalia chebula, Aloe barbandensis, Asphaltum, Piper longum, oxide od Zinc and Artemisia nilagirica, in a defined weight for the management of viral infections.
In another embodiment, the present invention provides a method of preparing the said composition for the management of coronavirus infections, comprising the steps of (a) identifying, washing and agitating each herb followed by assembling and cooking together in a rotary extractor to obtain a decoction liquid; (b) mixing the decoction liquid obtained in step (a) in a continuous rotary motion under strict control of the desired extraction temperature and timing; (c) passing the mixed decoction liquid obtained in step (b) into low-temperature vacuum evaporator followed by concentrating the decoction liquid to obtain a viscous liquid; and (d) piping the viscous liquid obtained in step (a) into the flow coater (granulator) for spraying the concentrate onto minute particles of powdered herbs (base material) and drying them to obtain concentrated granules, weighing and pressing to obtain herbal composition.
The above objects and advantages of the present invention will become apparent from the hereinafter set forth brief description of the drawings, detailed description of the invention, and claims appended herewith.

BRIEF DESCRIPTION OF THE DRAWINGS
An understanding of the novel process of the present invention may be obtained by reference to the following drawings:
Figure 1 illustrates the flow chart depicting the study conducted on the eligible patients.
Figure 2 illustrates the graphical representation showing the number of patients with negative RT-PCR (virological cure) results at Day 5 and Day 10 between the herbal composition (component A + component B) and Standard of care groups.
Figure 3 illustrates the graphical representation showing time to clinical improvement between the herbal composition (component A + component B) and Standard of care groups.
Figure 4 illustrates the graphical representation for number of patients showing abnormal chest finding between the herbal composition (component A + component B) group and Standard of Care groups.
Figure 5 illustrates ALP (IU/L) values at Baseline and Day 5/10 in herbal composition (component A + component B) group and Standard of Care groups.
Figure 6 illustrates the number of subjects with normal ECG on baseline (day1) and day 5/10 in herbal composition (component A + component B) and Standard of Care.
Figure 7 illustrates the change of improvement from baseline in ECG results between the herbal composition (component A + component B) and Standard of Care groups.

DETAILED DESCRIPTION OF THE INVENTION
The present invention now will be described hereinafter with reference to the detailed description, in which some, but not all embodiments of the invention are indicated. Indeed, the invention may be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will satisfy applicable legal requirements. Like numbers refer to like elements throughout. The present invention is described fully herein with non-limiting embodiments and exemplary experimentation.
The present invention relates to a composition for the management of viral infections. More particularly, the present invention provides a herbal composition of component A and Component B and method for the preparation of said composition for the management of COVID-19 with ten prong multifaceted approach.
In an embodiment, the present invention provides a component A which is a combination of phytochemicals, amino acids, vitamins and minerals. The Phytochemicals include plant extracts of Echinacea extract (Echinacea purpurea, 4.0% total polyphenols), Aloe Vera, and Cat's Claw extract (Uncaria tomentosa, bark, more than 3.0% alkaloids). Furthermore, the Amino acids include L- glutamine, L-arginine, L-lysine HCl, and L- Isoleucine. The Vitamins and minerals include Magnesium gluconate (5.86% magnesium), Copper gluconate (14.44% copper), Zinc gluconate (14.35% zinc).
In an embodiment, the present invention the Phytochemicals constituents of component A comprises Echinacea extract -10-15%, Aloe Vera 80 -10-15%, and Cat's Claw extract – 10-15%. The Amino acid constituent of component A comprises L- glutamine -10-20%, L-arginine -10-15%, L-lysine HCl – 0-10%, and L- Isoleucine-1-5%. The Vitamins and minerals constituent of component A include Magnesium gluconate -0-10%, Copper gluconate -1-5%, and Zinc gluconate -0-5%.
In an embodiment, the invention provides the composition of the component B which is a combination of polyherbal mixture of Andrographis panicullata (5-10%), Phylanthus niruri (5-10%), Glycirhizza glabra (5-10%),, Ocimum sanctum (1-5%), Tinsopsora cordiflolia (5-10%), Inula racemose (5-10%), Alpinia galangal (1-5%), Vitis vinifera (1-5%), Curcuma longa (1-5%), Terminalia chebula (1-5%), Aloe barbandensis (1-5%), Asphaltum (1-5%), Piper longum (1-5%), oxide of Zinc(1-5%), and Artemisia nilagirica (5-10%). The excipients used in the component A and component B is selected from the commonly used pharmaceutically acceptable ingredients. The pharmaceutically acceptable ingredients are selected from preservatives, binders, polymers, surfactant and lubricants. Furthermore, the preservative is paraben, the binder is gum acacia, the polymer is methyl cellulose, the surfactant is selected from polysorbate 80, sodium lauryl sulphate, and the lubricant is selected from talc, silica or magnesium stearate.
Andrographis panicullata is native to India and Sri Lanka, while Phylanthus niruri originated in India, and it is native to tropical coastal areas. Glycirhizza glabra grows in a belt from North Africa, across the Middle East and to China, Ocimum sanctum is native to the Indian subcontinent and grows throughout Southeast Asia, Tinsopsora cordiflolia is indigenous to tropical regions of the Indian subcontinent. Inula racemose is an Asian plant in the daisy family native to the temperate and alpine western Himalayas of Xinjiang, Afghanistan, Kashmir, Nepal, Pakistan. Alpinia galangal is commonly found in Indonesia and Malaysia. Vitis vinifera is native to the area near the Caspian Sea in southwestern Asia, Curcuma longa is thought to originate from southern Asia, most probably from India, Terminalia chebula occurs naturally from the sub-Himalayan region of Nepal and northern India to Sri Lanka, Myanmar, Thailand, Indo-China and southern China, Aloe barbandensis originates from the Arabian peninsula, Piper longum is native to southern India and Sri Lanka, Artemisia nilagirica is found in the hilly areas of India, and Echinacea purpurea find its origin from North America and is employed by the indigenous Indians.
In an embodiment, the present invention provides a herbal composition is an oral dosage form which is preferably a tablet or a capsule but is not limited to, granules, paste, pill, syrup or liquid and other suitable dosage forms. Furthermore, the component A is in tablet form and the component B is in capsule form.
Moreover, the present invention provides a ten prong multifaceted solution for the management of COVID-19. The ten prong, multifaceted approach includes but is not limited to increasing cellular immunity, bronchodilation, undocking the virus from ACE2 receptors, docking into the virus with specific plant DNA, anti-inflammatory action, anti-coagulation action, prevention of Cytokine Storms, dissolves viral envelopes, vagus nerve toning and intercellular transport. The herbal extracts are derived from whole plant or aerial parts or different parts of the plant such as root, bark, leaf, fruit, flower buds, oleo resin/gum and the like.
In another preferred embodiment, the present invention provides a method of preparing the herbal composition for the management of coronavirus infections, said method comprising steps of (a) identifying, washing and agitating each herb followed by assembling and cooking together in a rotary extractor to obtain a decoction liquid; (b) mixing the decoction liquid obtained in step (a) in a continuous rotary motion under strict control of the desired extraction temperature and timing; (c) passing the mixed decoction liquid obtained in step (b) into low-temperature vacuum evaporator followed by concentrating the decoction liquid to obtain a viscous liquid; and (d) piping the viscous liquid obtained in step (a) into the flow coater (granulator) for spraying the concentrate onto minute particles of powdered herbs (base material) and drying them to obtain concentrated granules, weighing and pressing to obtain said composition.
In yet another preferred embodiment of the present invention, the quantity of ingredients used in herbal composition varies depending upon the body weight of a subject and the mode of administration and is of any effective amount to achieve desired management effect. The method of managing the symptoms is associated with novel coronavirus by administering the herbal composition(s) to the patient in need thereof. The composition is administered via oral route which is preferably a tablet but is not limited to capsule, granules, paste, pill, syrup or liquid and other suitable dosage forms. The decoction liquid is mixed with strict action of extraction temperature and timing. The individual herbs are blended with solvents and are extracted individually and mixed in proportion as required.
Accordingly, the process for preparation of tablet composition of the present invention comprises the steps of:
(a) Extraction: Each herb included in the formulation composition is properly identified, cleaned, washed, and agitated to remove the foreign materials. The ingredients are then assembled and cooked together in a rotary extractor. A continuous rotary motion thoroughly mixes the decoction liquid with strict control of the extraction temperature and timing.
(b) Evaporation (Concentration): Once extraction is complete, the content is passed through rotary extractor and the decoction flows directly into a low-temperature vacuum evaporation-concentration system.
(c) Granulation and Tableting: From the concentration chambers the herbs now in the form of a viscous liquid, are piped into a flow coater in a closed system, there is a 0% chance of cross-contamination as the flow coater (granulator) sprays the concentrate onto minute particles of base material and dries them to create concentrated granules.
(d) In extraction step, super critical (CO2) extraction of the plant material undergoes a process of identifying and using specific plant part, cleaning and powdering and the powder obtained is then placed in an extraction vessel which undergoes high temperature and pressure of CO2 gas. A pump then forces super critical CO2 into the extraction vessel where it meets the plant and breaks the trichomes allowing it to dissolve part of the plant material.
Alternately, the extraction process uses the solvents selected from polar and non-polar solvents such as water, alcohols, hydro-alcohols n-hexane, petroleum ether, dichloromethane, chloroform, acetone and such like either alone or in combination thereof.
Furthermore, the composition in present invention shows that it is even more effective than pharmaceutical medicine as the composition in clinical trials resolved COVID-19 symptoms in three days while the pharmaceutical SOP (standard operating procedure) took eight days on an average.

EXAMPLE 1
Table 1
Composition of component B
Sl. No Common Name Hindi (Standardized to) Botanical Name/English Name Part Used Quantity
mg Percentage
1 Kalmegh Andrographis panicullata Whole plant
40 8%
2 Bhunimbha Phylanthus niruri Whole plant
40 8%
3 Yastimadhu Glycirhizza glabra Root 40 8%
4 Tulsi Ocimum sanctum Aerial part 20 4%
5 Guduchi Tinospora cordifolia Ghana satwa
40 8%
6 Pushkarmool Inula racemose Root 30 6%
7 Rasna Alpinia galangal Root 20 4%
8 Draksha Vitis Vinifera Fruit/seed 20 4%
9 Haridra Curcuma longa Rhizome 10 2%
10 Haritaki Terminalia chebula Fruit
20 4%
11 Kumari Aloe barbandensis Leaf 20 4%
12 Shilajit- Asphaltum Mineral 15 3%
13 Jasad Bhasma Oxide of zinc Powder 15 3%
14 Pippali Piper longum Fruit 5 1%
15 Damanaka/Damar Artemisia nilagirica Aerial part 40 8%
395 79%
Excipients 21%
TOTAL 500

Table 2
Composition of component A
S. No. Common name Quantity (mg) Percentage (%)
1. Echinacea dry extract 80 11%
2. Aloe vera dry extract 80 11%
3. Cat’s Claw dry extract 80 11%
4. L-Glutamine 140 20%
5. L-Arginine 80 11%
6. L-Lysine HCl 40 5.5%
7. L- Isoleucine 20 3%
8. Magnesium gluconate 40 5.5%
9. Copper gluconate 3.5 0.5%
10. Zinc gluconate 25 3.5%
11. Excipients 91.5 13%
Total 720

The components the herbal composition are illustrated in Table 1 (component B) and Table 2 (component A). All the constituents of the component A were procured from Bhagvati Herbal & Healthcare Pvt. Ltd, Valsad and the constituents of Component B were procured from Mittal Ayurved Sansthan, Meerut.
EXAMPLE 2
In vitro Cytotoxicity of Component A
The test material was prepared according to OECD-129 documents. The Neutral Red Uptake Cytotoxicity assay (NRU) in vitro basal Cytotoxicity assay procedure is based on the ability of viable cells to incorporate and bind neutral red (NR), a supravital dye (Borenfreund and Puerner, 1985). In the present study, the NRU assay is performed in a dose-response format to determine the concentration that reduces NRU by 50% compared to the controls (i.e. the IC50). The IC50 value is used in a linear regression equation to estimate the oral LD50 value (dose that produces lethality in 50% of the animals tested), which is then used to determine a starting dose for acute oral systemic toxicity testing using rats for the UDP, the ATC method, or FDP.
Test Method
The A549 cell line was obtained from Institute stock. A Bio Rad Elisa Reader was used for absorption analysis. The 96-well flat-bottom tissue culture trays were obtained from Corning (Corning). DMEM from GIBCO Laboratories was supplemented with 10% foetal bovine serum, 100 unit’s/ml penicillin, 100 pg/ml streptomycin and 2.5 pg./ml fungizone (complete medium). Stock cultures of A549 cells were first grown in 75 cm2 culture flask and after three days when the confluence has reached 80% cells were trypsinized with 0.05% trypsin-0.02% versene, and 2 x l03 to 2.2 x l03 cells were seeded to designated well of the 96 wells. Cells were allowed to attach over a 24 hours’ period, after 24 hours the plate was observed under inverted microscope to check the cell platting. After that 0.2 ml of test agents in fresh medium of different concentration, positive control in different concentration, and vehicle control(Medium) were added to the semi confluent culture. Each concentration was tested in triplicate wells and cells were incubated for 24 hours. Cultures were then scanned with an inverted microscope equipped with phase optics and cells scored morphologically for cytotoxic effects. The medium was then removed and each well rinsed with Hanks balanced salt solution before the NR assay was performed.
Procedure
• The well was seeded from the stock cell suspension (early cells were grown in 75 cm2 culture flask) at a concentration of (2x103 – 2.5x103 cells/well).
• The plates were prepared in a manner as per Institute SOP i.e., one plate per substance to be tested.
• Incubate cells (37ºC ±1ºC, 90% ±10% humidity, and 5% ±1% CO2/air) so that cells form a 20+% monolayer (~48-72 hours). This incubation period assures cell recovery and adherence and progression to exponential growth phase.
• The Plates were monitored under a phase contrast microscope to assure that cell growth is relatively even across the microtiter plate after 24 hours of platting. This check is performed to identify experimental and systemic cell seeding errors.
• The Plating was done according to below (Table 3) for the current Analysis:

Table 3
Plating for the current analysis
1 2 3 4 5 6 7 8 9 10 11 12
A B VC C-1 C-2 C-3 C-4 C-5 A
B B VC C-1 C-2 C-3 C-4 C-5 A
C B VC C-1 C-2 C-3 C-4 C-5 A
D B VC D-1 D-2 D-3 D-4 D-5 A
E B VC D-1 D-2 D-3 D-4 D-5 A
F B VC D-1 D-2 D-3 D-4 D-5 A
G
H

B = Blank (only medium without cells)
A = Medium with cells
VC = Vehicle Control
C-1 to C-5 = Different Concentration of Test
It is evident from Table 5 that the test material is non Cytotoxic as its IC50 is 833.29 µg/ml. Thus findings suggest that the test sample and control sample is not toxic for cell growth and the data is presented in Table 4.

Table 4
Analysis result of NRU Assay
Test Test Item Concentration (µg/ml) Mean OD SD Mortality (%)
Vehicle Control -
Negative Control -
Positive Control
Test 1 0.1 10
Test 2 1.0 20
Test 3 10.0 40
Test 4 100.0 60
Test 5 1,000.0 100

Table 5
IC50 Regression Results [Data 1]
Parameter Value
IC50 833.2989
Equation
Equation Form

Under the conditions of this study, it has been concluded that medical device extract did not created any significant toxicity toward human cells. Results clearly indicated that the “component A” was non-Cytotoxic on A 549 cells and all procedures were conducted in conformance with good laboratory practices results and conclusions apply only to the test article tested.
EXAMPLE 3
Referring to Figure 1 of the present invention, is illustrated a flow chart depicting the study conducted on the eligible patients. This is an open label, randomized, comparative, multi-centric, parallel group and controlled study. The study was conducted at 4 centres in India, having qualified Investigators. After obtaining the informed consent from ethics committee (EC), patients were screened by undergoing various assessments as mentioned in Schedule of Assessment and after confirming eligibility, eligible patients were randomized in the study and assigned either to the test group receiving a treatment regime of herbal combination therapy of component A and component B or in a control group with best standard of care as per institutional practice, for 10 days treatment period and were given randomization number based on computer generated randomization. Patients were hospitalized during the treatment period. During the study, Specimen Collection, Packaging and Transport of Nasopharyngeal swab and Oropharyngeal swab were done as per regulations and keeping in mind GCP and GLP practices.
EXAMPLE 4
Treatment Administered
Two groups of the subjects were divided in 1:1 ration, based upon the treatment administered.
The treatment administered to the study group was test product 2 tablets component A, 500 mg tablets thrice and 1 capsule component B, 500 mg twice a day for a period of up to 11 days. For control group the treatment and dose as per hospital protocol for COVID-19 was administered. As per patient’s clinical condition, the following medicines were getting prescribed under standard of care, SOS basis on and off as per the clinical improvement, which included Tab. Paracetamol 650 mg (SOS), Tab. B Complex (OD), Tab. Vit C 500 mg (TID), Tab. Cetrizine 10 mg (OD), Tab. Pantaprazole 40 mg (OD), Tab. Azithromycin 500 mg (OD) and Tab. Favipravir 800 mg (SOS).
EXAMPLE 5
Referring to Figure 2 of the present invention, is illustrated the number of patients with negative RT-PCR (virological cure) results at Day 5 and Day 10 between herbal composition (component A + component B) and Standard of care groups. The focus of this study is to determine the efficacy, safety and tolerability of polyherbal blends of component A and component B and in the treatment of mild to moderate COVID-19. The primary efficacy variable is the number of days to clinical improvement from study enrolment till the day of discharge. Secondary efficacy variables are normalization of fever, change in the mean values of SpO2, Respiratory rate, RT-PCR, Haematology and Biochemistry from baseline to day of discharge. Change in quality of life from baseline to Day 5. The result of the above study is presented in the Table 6 and Table 7.

Table 6
Number of patients with negative RT-PCR (virological cure) at Day 5 between the herbal composition (component A + component B) and Standard of care groups
RT-PCR Herbal composition (Component A + Component B (N=50) Standard of care (N=50) P-value* P-value#
Baseline Day 5 Day 10 Baseline Day 5 Day 10
Proportion of patients that had negative PCR 0/50 44/50 50/50 0/50 36/50 44/50 0.04 0.02

*P-value calculated between Day 5 values between herbal composition (component A + component B) and Standard of care groups; #P-value calculated between Day 10 values between component A + component B and Standard of care groups.

Table 7
% Number of patients that had negative RT-PCR (virological cure) at Day 5 and Day 10 between herbal composition (Component A + Component B) and Standard of care groups
RT-PCR composition (component A + component B) (N=50) Standard of care (N=50)
Day 5 Day 10 Day 5 Day 10
% of subjects in Virological cure 88 100 72 88

Referring to Figure 3 of the present invention, is illustrated the time to clinical improvement herbal composition (component A + component B) and Standard of care groups.
• Change in clinical laboratory findings (e.g., BUN, SGOT, SGPT and Creatinine)
• Incidence of adverse events. Adverse events were classified according to their severity based on CTCAE v 5.0 criteria. Any clinically significant abnormal change from baseline in the concurrent medical condition(s), physical examination and/or laboratory data was recorded as an AE.
• 12 lead ECG was conducted at screening, on Day 5 and if required on Day 10, and as clinically indicated.
All adverse events (AEs) and SAE were recorded at each visit to assess safety of the IP. The results relating to the above clinical findings are presented in Table 8 to Table 14.
Referring to Figure 4 of the present invention, is illustrated Number of patients showing abnormal chest finding between herbal composition (component A + component B) and Standard of Care groups. The result of the same is presented in Table 8.
Referring to Figure 5 of the present invention, is illustrated ALP (IU/L) values at Baseline and Day 5/10 in herbal composition (component A + component B) group and Standard of Care groups

Table 8
Cumulative proportion of patients in normal chest finding between herbal composition (component A + component B) and Standard of Care groups
Parameter composition (component A + component B) (N = 50) Standard of Care (N = 50) P value*
Chest X-ray Baseline Day 5 Day 10 Baseline Day 5 Day 10
Cumulative proportion of patients showing normal chest finding 22/50 40/50 48/50 22/50 35/50 44/50 0.306
% Cumulative proportion of patients showing normal chest finding 44 80 96 50 70 88

Results from Table 9 shows that % Cumulative proportion of patients showing normal chest finding was greater than the standard of care treatment. *The result is not significant at p<.05
Table 9
CRP mean values at Baseline and Day 5/10 herbal composition (component A + component B) group and Standard of Care groups
Lab Tests Variable Herbal composition (component A + component B) (N = 50) Standard of Care (N = 50)
CRP (mg/dL) Baseline Day 5 (N=50) Day 10 (N=6) Baseline (N=50) Day 5 (N=50) Day 10 (N=14) p-value*
Mean 4.16 1.45 1.35 4.02 1.38 1.20 0.78
SD 2.61 0.37 0.1 2.79 0.14 0.40
P-value# 0.01 0.02

*The result is not significant at p<.05, #The result is significant at p<.05.

Table 10
Blood oxygen saturation (SpO2) values at Baseline, Day 5 and Day 10 in herbal composition (component A + component B) compared to Standard of care group
Test Variable Herbal Composition (component A + component B) Standard of Care p-value*
SpO2 (%) Day 0 (N=50) Day 5 (N=50) Day 10 (N=6) Day 0 (N=50) Day 5 (N=50) Day 10 (N=14)
Mean 94.57 97.33 98.36 94.53 96.57 97.33 0.43
SD 2.54 1.19 1.50 2.45 1.78 2.42
P-value# 0.03# 0.07

*The result is not significant at p<.05; #The result is significant at p<.05.
Referring to Figure 6 of the present invention, is illustrated the number of subjects with normal ECG on baseline (day1) and day 5/10 in herbal composition (component A + component B) and Standard of Care. (Table 11) and Figure 7 illustrates the change of improvement from baseline in ECG results between the herbal composition (component A + component B) and Standard of Care groups.
Table 11
ECG evaluation between herbal composition (component A + component B) and Standard of Care groups.
Parameter Herbal composition (component A + component B) (N=50) Standard treatment (N=50) P-value*
ECG Baseline Day 5/10 Baseline Day 5/10 0.02
Normal 26 46 23 38
% improvement 76.9 65.2

It is evident from Table 11 that the % improvement for the herbal composition was significantly higher than the standard of care in ECG evaluation. *The result is significant at p<.05 when compared of Day 5/10 results

Table 12
Total Adverse Events
S. No. AE Herbal composition (component A + component B) Standard of care (N=50)
1 No. of AEs 1 6

Table 13
Adverse events in herbal composition (component A + component B) treatment group
S. No. Sub. No. AE Intensity AE treatment Action Taken Outcome
1. 03 Mouth Ulcers Mild None None Self-resolved

Table 14
Adverse events in Standard of care group
S. No. Sub. No. AE Intensity AE treatment Action taken Outcome
1. 4 Vertigo Mild Non-Pharmacological treatment None Self-resolved
2. 12 Mouth Ulcers Mild None None Self-resolved
3. 13 Dizziness Moderate None None Self-resolved
4. 27 Drowsiness Mild None None Self-resolved
5. 31 Nausea and vomiting Mild None None Self-resolved
6. 42 Nausea and vomiting Mild None None Self-resolved
7. 58 Vertigo Mild None None Self-resolved

It is evident from Tables 12, 13 and 14 that the adverse effects in the herbal composition treatment were negligible when compared to standard of care.
In conclusion, the time to 2-point clinical improvement as per 7-point ordinal WHO scale was seen favour in herbal compositions (component A + component B) group when compared to the standard of care. The results were significant. The herbal composition (component A + component B) treatment was very effective in virological results. The herbal compositions (Component A + component B) treatment reduced the Covid-19 symptoms when compared to the baseline. It reduces the Inflammatory marker CRP levels (Table 9) when compared to the baseline and also when compared to the standard of care. It improves the Blood oxygen saturation levels (Table 10). It improved the chest findings in Chest X-Ray (Table 8). All the biochemical tests were normal at baseline and post study. There were no serious adverse events reported in the study. Overall the herbal compositions (component A + component B) group was very effective in treating the Covid-19 patients. The herbal compositions (component A + component B) group was tolerated very well in Covid-19 patients. The overall results in the Intervention are encouraging for Mild to Moderate Covid-19 cases.
Many modifications and other embodiments of the invention set forth herein will readily occur to one skilled in the art to which the invention pertain having the benefit of the teachings presented in the foregoing descriptions and the associated drawings. Therefore, it is to be understood that the invention is not to be limited to the specific embodiments disclosed and that modifications and other embodiments are intended to be included within the scope of the appended claims. Although specific terms are employed herein, they are used in a generic and descriptive sense only and not for purposes of limitation.
,CLAIMS:CLAIMS

We claim:
1. A herbal composition comprising:
a component A;
a component B; and
pharmaceutically acceptable excipients;
wherein,
said component A is a combination of phytochemicals, amino acids, vitamins and minerals in a defined weight percentage;
said component B is a combination of polyherbal mixture of Andrographis panicullata, Phylanthus niruri, Glycirhizza glabra, Ocimum sanctum, Tinsopsora cordiflolia, Inula racemose, Alpinia galangal, Vitis vinifera, Curcuma longa, Terminalia chebula, Aloe barbandensis, Asphaltum, Piper longum, oxide of Zinc and Artemisia nilagirica; and
said composition is useful for management of COVID-19 symptoms.
2. The composition as claimed in claim 1, wherein the polyherbal mixture of component B comprises of:
Andrographis panicullata (5-10%);
Phylanthus niruri (5-10%);
Glycirhizza glabra (5-10%); Ocimum sanctum (1-5%);
Tinsopsora cordiflolia (5-10%);
Inula racemose (5-10%);
Alpinia galangal (1-5%);
Vitis vinifera (1-5%);
Curcuma longa (1-5%);
Terminalia chebula (1-5%);
Aloe barbandensis (1-5%);
Asphaltum (1-5%);
Piper longum (1-5%);
oxide of Zinc (1-5%); and
Artemisia nilagirica (5-10%).
3. The composition as claimed in claim 1, wherein the Phytochemical constituents of component A comprises of Echinacea extract (10-15%); Aloe Vera (10-15%); and Cat's Claw extract (10-15%).
4. The composition as claimed in claim 1, wherein the amino acid constituents of component A comprises of L- glutamine (10-20%); L-arginine (10-15%); L-lysine HCl (0-10%); and L- Isoleucine (1-5%).
5. The composition as claimed in claim 1, wherein the Vitamins and minerals constituents of component A comprises of Magnesium gluconate (0-10%); Copper gluconate (1-5%); and Zinc gluconate (0-5%).
6. The composition as claimed in claim 1, wherein the pharmaceutically acceptable ingredients include but are not limited to preservatives, binders, polymers, surfactant and lubricants.
7. The composition as claimed in claim 4, wherein the preservative is paraben, the binder is gum acacia, the polymer is methyl cellulose, the surfactant is selected from polysorbate 80, sodium lauryl sulphate, and the lubricant is selected from talc, silica or magnesium stearate.
8. The composition as claimed in claim 1, wherein the component A is in tablet form and the component B is in capsule form.
9. The composition as claimed in claim 1, wherein the composition helps reducing viral loads in subjects with efficacy of 88% when administered for five days and 100% when administered for ten days.
10. The composition as claimed in claim 1, wherein the composition helps clearing chest congestion in subjects with an efficacy of 44% when administered for a day, 80% when administered for five days, and 96% when administered for ten days.