A Composition for Management of COVID-19 and Associated Disorders

Abstract

The present disclosure provides a composition that may find utility in management of COVID-19. The inventors of the present disclosure surprisingly observed that ingredients of the composition of the present disclosure exhibit functional synergy therebetween, wherein the composition prevents virus replication and/or Virus entry into human cells, either wholly or in part, while modulating immune response of the patient. Hence, the composition of the present disclosure holds potential for wide spread usage in management of COVID-19, either alone or in combination with other preventive or palliative/symptomatic or therapeutic strategies.

Claims

1. A composition for management of COVID-19 and associated disorders, said composition comprising: (i) active constituents comprising: Hesperidin in an amount ranging from 10% to 25% by weight of the active constituents; Curcumin in an amount ranging from 15% to 35% by weight of the active constituents; Epigallocatechin in an amount ranging from 15% to 30% by weight of the active constituents; Rutin in an amount ranging from 10% to 25% by weight of the active constituents; Quercetin in an amount ranging from 0.5% to 8% by weight of the active constituents; Luteolin in an amount ranging from 1% to 10% by weight of the active constituents; Baicalin in an amount ranging from 1% to 15% by weight of the active constituents; and Piperine in an amount ranging from 0.03% to 3% by weight of the active constituents; and (ii) one or more excipients.

2. The composition as claimed in claim 1, wherein the composition comprises active constituents in an amount ranging from 1% to 20% by weight of the formulation and the rest being one or more excipients.

3. The composition as claimed in claim 1, wherein the excipient includes any or a combination of: a bulking agent, a solubilizer, a binder, a lubricant, a thickening agent, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a suspending agent, a buffering agent, a preservative, and a solvent.

4. The composition as claimed in claim 1, wherein the composition is formulated into a lozenge, a tablet, an ingestible liquid, a syrup, a suspension, a nasal drop, an injectable solution, an aerosol and a liquid ready for nebulization.

5. An orally ingestible suspension formulation for management of COVID-19 and associated disorders, said formulation comprising: (i) active constituents comprising: Hesperidin in an amount ranging from 10% to 25% by weight of the active constituents; Curcumin in an amount ranging from 15% to 35% by weight of the active constituents; Epigallocatechin in an amount ranging from 15% to 30% by weight of the active constituents; Rutin in an amount ranging from 10% to 25% by weight of the active constituents; Quercetin in an amount ranging from 0.5% to 8% by weight of the active constituents; Luteolin in an amount ranging from 1% to 10% by weight of the active constituents; Baicalin in an amount ranging from 1% to 15% by weight of the active constituents; and Piperine in an amount ranging from 0.03% to 3% by weight of the active constituents; and (ii) one or more excipients.

6. The formulation as claimed in claim 5, wherein the one or more excipients includes a bulking agent, a solubilizer, a binder, a lubricant, a thickening agent, a flavouring agent, a colouring agent, a tonicity agent, a sweetening agent, a buffering agent, a suspending agent, a preservative, and a solvent.

7. The formulation as claimed in claim 5, wherein the suspension formulation comprises active constituents in an amount ranging from 1% to 20% by weight of the formulation and the rest being one or more excipients.

8. A composition for management of COVID-19 and associated disorders, said composition comprising: (i) active ingredients comprising: an extract of Citrus reticulata in an amount ranging from about 2% to about 20% by weight of the active ingredients; an extract of Curcuma longa in an amount ranging from about 5% to about 20% by weight of the active ingredients; an extract of Camellia sinensis in an amount ranging from about 5% to about 25% by weight of the active ingredients; an extract of Sophora japonica L. in an amount ranging from about 10% to about 40% by weight of the active ingredients; an extract of Arachis hypogaea in an amount ranging from about 2% to about 20% by weight of the active ingredients; an extract of Oroxylum indicum in an amount ranging from about 20% to about 40% by weight of the active ingredients; and an extract of Piper nigrum L. in an amount ranging from about 0.01% to 3.0% by weight of the active ingredients; and (ii) one or more excipients.

9. The composition as claimed in claim 8, wherein the composition comprises active ingredients in an amount ranging from 1% to 20% by weight of the composition and the rest being one or more excipients.

10. The composition as claimed in claim 8, wherein the composition is formulated as an orally ingestible liquid.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0075] The following drawings form part of the present specification and are included to further illustrate aspects of the present disclosure. The disclosure may be better understood by reference to the drawings in combination with the detailed description of the specific embodiments presented herein.

[0076] FIGS. 1A and 1B illustrate snippets depicting the effect of the developed composition on histopathology of hearts of rats suffering from myocardical infarction as compared to the Control group FIG. 2 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on patient's report turning negative in days (RT-PCR) in COVID-19 positive patients from day 0 to 14, in accordance with the embodiments of the present disclosure.

[0077] FIG. 3 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on CT value (Viral Load) of COVID-19 positive patients from day 0 to 5, in accordance with the embodiments of the present disclosure.

[0078] FIG. 4 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum IL-6 levels (pg/mL) of COVID-19 positive patients from day 0 to 5 and 0 to 12, in accordance with the embodiments of the present disclosure.

[0079] FIG. 5 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CRP levels (mg/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12, in accordance with the embodiments of the present disclosure.

[0080] FIG. 6 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum Total antibody levels (mg/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12, in accordance with the embodiments of the present disclosure.

[0081] FIG. 7 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CPK levels (U/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12, in accordance with the embodiments of the present disclosure.

[0082] FIG. 8 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum D-Dimer levels (pg FEU/L) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0083] FIG. 9 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum ferritin levels (pg/L) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0084] FIG. 10 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CD4 levels (cells/pL) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0085] FIG. 11 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CD8 levels (cells/pL) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0086] FIG. 12 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CD19 levels (cells/pL) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0087] FIG. 13 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on serum CD16/56 levels (cells/pL) of COVID-19 positive patients from day 0 to 12, in accordance with the embodiments of the present disclosure.

[0088] FIG. 14 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on COVID-19 patients at risk (staying positive) from day 0 to 14, in accordance with the embodiments of the present disclosure.

[0089] FIG. 15 illustrates an exemplary graph depicting the effect of SV9 (S+ V9) and S on cumulative no. of COVID-19 patients turning negative, in accordance with the embodiments of the present disclosure.

[0090] FIG. 16 illustrates a graph depicting the effect of SV9 (S+ V9) on patients (n=62 in each group) suffering from COVID-19, showing the percentage of patients with normal and abnormal findings of X-ray from day 0 to 45 of COVID-19 infection, in accordance with the embodiments of the present disclosure.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Examples

Preliminary Study

[0091] Coronavirus disease (COVID-19) has emerged as a pandemic and a public health crisis of global proportions. Most people who fell sick with COVID-19 experiences mild to moderate symptoms and recover without any special treatment. However, certain disorders have been associated with patients experiencing moderate to severe symptoms. Predominantly, such disorders associated with COVID-19 includes cytokine storm, acute lung inflammation, myocardial injury such as myocardial infarction, blood thickening and/or clot formation, impairment of brain function, breathlessness, body, joint and muscle pain and the likes, myocardial injury being the most notable posing a serious health problem. Keeping that in view, preliminary studies were conducted to understand the effects of Epigallocatechin gallate (EGCG) alone, Baicalin alone, Quercetin alone and when given as a combination, in an isoproterenol induced myocardial infarction rat model. Inventors of the present disclosure surprisingly observed that EGCG, Baicalin and Quercetin when given in combination, exhibits functional synergy therebetween, wherein the combination significantly reversed the parameters associated with myocardial infarction when compared to the individual treatments.

[0092] Preliminary study was carried out on total 60 rats that were equally divided into five groups: Group 1, Group 2, Group 3, Group 4 and Group 5. Group 1 represents the rats treated with the Isoproterenol at a dose of 90 mg/kg body weight (i.e. Control group); Group 2 represents the rats treated with—Isoproterenol 90 mg/kg body weight+Epigallocatechin gallate (EGCG) 138 mg/kg body weight; Group 3 represents the rats treated with—Isoproterenol 90 mg/kg body weight+Baicalin 138 mg/kg body weight; Group 4 represents the rats treated with—Isoproterenol 90 mg/kg body weight+Quercetin 138 mg/kg body weight; and Group 5 represents the rats treated with—Isoproterenol 90 mg/kg body weight+a combination containing EGCG 91.4 mg/kg body weight, Baicalin 36.3 mg/kg body weight and Quercetin 10.3 mg/kg body weight (a total of 138 mg/kg body weight).

[0093] Provided herein-below, in Table 2, are the results of the preliminary study establishing synergism between EGCG, Baicalin and Quercetin.

TABLE-US-00002 TABLE 2 Efficacy of compositions on isoproterenol induced myocardial infarction rat model PARAMETERS GROUPS GPT GOT LDH TNF-A Group 1 92.83 109.17 188.33 577.56 (Isoproterenol - 90 mg/kg bwt.) Group 2 75.30 139.15 408.29 (Isoproterenol -  mg/kg bwt. + EGCG 138 mg/kg bwt.) Group 3 79.57 110.37 138.67 438.58 (Isoproterenol - 90 mg/kg bwt. + Biacalin 138 mg/kg bwt.) Group 4 90.47 103.33 121.00 411.70 (Isoproterenol - 90 mg/kg bwt. +  138 mg/kg bwt.) Group 5 74.17 97.43 119. 400.47 (Isoproterenol - 90 mg/kg bwt. + mixture 138 mg/kg bwt.) indicates data missing or illegible when filed

[0094] From Table 2, it is evident that EGCG, Baicalin and Quercetin when given in combination, they exhibits functional synergy therebetween, wherein the combination significantly reversed the parameters GPT, GOT, LDH and TNF-a associated with myocardial infarction when compared with individual treatments at the same dosage.

[0095] Based on the preliminary studies, Inventors of the present disclosure conducted multiple experiments including other active constituents/plant extracts as part of the above mixture. After series of experiments, inventors of the present disclosure surprisingly arrived at a composition that prevents virus replication and/or virus entry into human cells, either wholly or in part, while modulating immune response of the patient. It could further be observed that the composition of the present disclosure aids in providing relief from the COVID-19 associated disorders such as cytokine storm, acute lung inflammation, blood thickening (or clot formation), renal damage, muscle & joint pain, and myocardial injury such as myocardial infarction.

Example 1—Orally Ingestible Suspension

Formulation

[0096] 50 ml orally ingestible suspension formulation was prepared, composition whereof is provided herein-below in Table 3:

TABLE-US-00003 TABLE 3 Suspension Formulation (V9) Active Constituents Amount (in mg) Hesperidin 725 Curcumin 1165 Epigallocatechin 996 Rutin 825 Quercetin 120 Lut 230 Baicalin 395 Piperine 15 Glycyrrhizin 529 (sweetening agent) Excipients q.s. to make 50 mL indicates data missing or illegible when filed

Efficacy (Retention of Synergistic Activity)

[0097] Efficacy of the developed composition (composition shown in Table 3) was assessed on the isoproterenol induced myocardial infarction rat model to confirm retention of the synergistic activity.

TABLE-US-00004 TABLE 4 Efficacy of the composition on isoproterenol induced myocardial infarction rat model PARAMETERS GROUPS GPT GOT LDH TNF-A Group 1 92.83 109.17 188.33 577.56 (Isoproterenol - 90 mg/kg bwt.) Group 2 74.53 94.47 123.67 (Isoproterenol - 90 mg/kg bwt. + V9 464 mg/kg bwt.) indicates data missing or illegible when filed

[0098] As can be seen from Table 4 above, the developed composition (as shown in Table 3 above) exhibits synergistic activity, comparable to (or even better than) the combination of EGCG, Baicalin and Quercetin, confirming that the presence of other active constituents does not hinder with the synergistic activity as regards reversal of the parameters GPT, GOT, LDH and TNF-a associated with/corresponding to the myocardial infarction. FIGS. 1A and 1B illustrate snippets depicting the effect of the developed composition (as shown in Table 3 above) on histopathology of hearts of rats suffering from myocardical infarction as compared to the Control group. Group 1 (FIG. 1A) rats showed myocardial degeneration, infiltration of inflammatory cells, and extra-vasated RBCs, whereas Group 2 (FIG. 1A) rats showed minimal myocardial degeneration, vacuolations, no infiltration of inflammatory cells or hemorrhages.

[0099] Clinical Trial

[0100] The suspension (V9) prepared in Example 1 above was subjected to clinical trial for management of COVID-19 and associated disorders. A randomized, open label, parallel efficacy, active control, multi-centre exploratory trial to evaluate efficacy and safety of the suspension (V9) as an adjunct treatment to standard treatment/standard intervention (hereinafter referred as S, provided herein below in Table 5) for the management of mild to moderate COVID-19 Patients. About 124 adults, exhibiting flu-like symptoms with confirmed COVID-19 RT-PCR test were selected for the study.

[0101] Study duration: Treatment—12±2 days and follow up—30 days.

[0102] Study Time-points: Screening (Day 2 to 0±2 days), Randomization & Hospitalization (Day 1 t 2 days), Day 5±2 days, Day 12 t 2 days and follow-up visit (Day 45±2 days)

[0103] Intervention: Patients were randomized to take either of the following drug regimens:

[0104] 1) Standard intervention, S (n-62)

[0105] 2) SV9 (Suspension formulation, V9+Standard intervention, S (n-62))

[0106] Dosage & administration: Standard intervention—as per the Ministry of Health and family welfare guidelines for COVID-19

[0107] Suspension formulation, V9 (5000 mg in 50 ml suspension per day)—Loading dose on day 1-25 ml each at 1 hour before breakfast, lunch and dinner; maintaining dose from day 2 to day 12±2 days—20 ml, 15 ml and 15 ml at 1 hour, before breakfast, lunch and dinner, respectively.

TABLE-US-00005 TABLE 5 Standard Care Treatment/Standard Intervention (S) Drug class or Therapeutic classification Medicine name Medicine name Antibiotic Doxycycline + Cefixime — Anti-pyretic Nutritional Supplement Vitamin C Vitamin C  Vitamin Calcium and Vitamin D3 C/Ascorbic Acid + L Lysine Multivitamin including Zinc Multivitamin Steroid Proton Pump — Inhibitor (PPI) Pro-biotic — indicates data missing or illegible when filed

[0108] FIG. 2 illustrates the effect of SV9 (S+ V9) on patient's report turning negative in days (RT-PCR) in COVID-19 positive patients from day 0 to 14 i.e. comparison of number of patients turning negative serum from day 0 to day 14, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention alone (3). Data represented as change in expected and observed values in two comparable interventional group (n=62 per group).

[0109] FIG. 3 illustrates the effect of SV9 (S+ V9) on CT value (Viral Load) of COVID-19 positive patients from day 0 to 5 i.e. comparison of mean difference in CT value per day (Viral Load) from day 0 to 5, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in CT value (Viral Load) levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, *p<0.001, ****P<0.0001 when compared before and after intervention at day 5 both interventional groups.

[0110] FIG. 4 Illustrates the effect of SV9 (S+ V9) on serum IL-6 levels (pg/mL) of COVID-19 positive patients from day 0 to 5 and 0 to 12. Data interpreted as following: comparison of serum IL-6 levels (pg/mL) from day 0 to 5 and 0 to 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum IL-6 levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****P<0.0001 when compared before and after intervention at day 5 and 12 in both interventional groups.

[0111] FIG. 5 Illustrates the effect of SV9 (S+ V9) on serum CRP levels (mg/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12. Data interpreted as following: comparison of serum CRP levels (mg/L) from day 0 to 5 and 0 to 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CRP levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ***P<0.0001 when compared before and after intervention at day 5 and 12 in both interventional groups.

[0112] FIG. 6 Illustrates the effect of SV9 (S+ V9) on serum Total antibody levels (mg/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12. Data interpreted as following: comparison of serum Total antibody levels (mg/L) from day 0 to 5 and 0 to 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum Total antibody levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001 when compared before and after intervention at day 5 and 12 in both interventional groups.

[0113] FIG. 7 illustrates the effect of SV9 (S+ V9) on serum CPK levels (U/L) of COVID-19 positive patients from day 0 to 5 and 0 to 12. Data interpreted as following: comparison of serum CPK levels (U/L) from day 0 to 5 and 0 to 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CPK levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, when compared before and after intervention at day 5 and 12 in both interventional groups.

[0114] FIG. 8 illustrates the effect of SV9 (S+ V9) on serum D-Dimer levels (pg

[0115] FEU/L) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum D-Dimer levels (pg FEU/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum D-Dimer levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****p<00001, when compared before and after intervention at day 12 in both interventional groups.

[0116] FIG. 9 illustrates the effect of SV9 (S+ V9) on serum ferritin levels (pg/L) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum ferritin levels (pg/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum ferritin levels (Mean±SEM) in two comparable interventional group (n=62 per group).

[0117] FIG. 10 Illustrates the effect of SV9 (S+ V9) on serum CD4 levels (cells/pL) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum CD4 levels (pg/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CD4 levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****P<0.0001, when compared before and after intervention at day 12 in both interventional groups.

[0118] FIG. 11 Illustrates the effect of SV9 (S+ V9) on serum CD8 levels (cells/pL) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum CD8 levels (pg/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CD8 levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****p<0.0001, when compared before and after intervention at day 12 in both interventional groups.

[0119] FIG. 12 Illustrates the effect of SV9 (S+ V9) on serum CD19 levels (cells/pL) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum CD19 levels (pg/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CD 19 levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****P<0.0001, when compared before and after intervention at day 12 in both interventional groups.

[0120] FIG. 13 Illustrates the effect of SV9 (S+ V9) on serum CD16/56 levels (cells/pL) of COVID-19 positive patients from day 0 to 12. Data interpreted as following: comparison of serum CD16/56 levels (pg/L) from day 0 to day 12, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in serum CD16/56 levels (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****p<00001, when compared before and after intervention at day 12 in both interventional groups.

[0121] FIG. 14 Illustrates the effect of SV9 (S+ V9) on COVID-19 patients at risk (staying positive) from day 0 to 14. Data interpreted as following: comparison of mean difference in patients remaining positive from day 0 to 14, when V9 5000 mg adjuvant with standard intervention (S) compared with standard intervention (S) alone. Data represented as change in number of patients remaining positive (Mean±SEM) in two comparable interventional group (n=62 per group). Significant at *p<0.05, **p<0.01, ***p<0.001, ****p<00001 when compared before and after intervention at day 5 both interventional groups.

[0122] FIG. 15 Illustrates the effect of SV9 (S+ V9) and S on cumulative no. of COVID-19 patients turning negative.

[0123] FIG. 16 illustrates a graph depicting the effect of SV9 (S+ V9) on patients (n=62 in each group) suffering from COVID-19, showing the percentage of patients with normal and abnormal findings of X-ray from day 0 to 45 of COVID-19 infection. At day 0, 37.10% (n=23/62) of patients had abnormal X-ray findings in standard intervention (S) and 90.32% (n=56/62) in SV9 group. After 12±2 days of treatment with S and SV9, only 22.95% (n=14/61) of patients had abnormal findings in SV9 group, resulting in 77.05% (n=47/61) of patients with normal findings compared with standard intervention (S) that shows no change in patient conditions starting from day 0.

[0124] Table 6 below illustrates effect of the composition of the present disclosure on Prothrombin Time (PT).

TABLE-US-00006 TABLE 6 Effect of the composition on Prothrombin Time (PT) PT (in seconds) Mean ± SEM Mean ± SEM Day 0 vs Day 0 vs Day 0 vs Intervention Day 0 Day 5 Day 12 Day 45 Day 5 Day 12 Day 45 Standard (S) 16.61 ± 0.24 16. 6 ± 0.26 16.48 ± 0.25 16.64 ± 0.34 (0.7638) (0.4095) (0.7747) SV9 16.15 ± 0.27 15.9  ± 0.48 15.7  ± 0.35 1 .66 ± 0.3 (0.62 2) (0.1388) (0.1022) indicates data missing or illegible when filed

Example 2: Orally Ingestible Suspension

[0125] 50 ml orally ingestible suspension formulation was prepared, composition whereof is provided in Table 7 below.

TABLE-US-00007 TABLE 7 Composition for orally ingestible suspension Active Constituents Amount (in mg)  extract 1052  extract Rutin  extract  extract 200  powder 100 Piper nigrum (as Piperine) extract 15 500 (sweetening agent) Other Excipients q.s. to make 50 mL indicates data missing or illegible when filed

[0126] The proposed composition along with alleviating infected persons also supports in faster recovery by providing Immuno-modulatory, Neuro-protective, Anti-Inflammatory, Vital organ/tissue protective and Anti-oxidant effects. The proposed composition is with optimum nutrition, non-toxic, natural herbal plant extracts, easy to digest, have health protective and rejuvenate functions to ameliorate the symptoms and/or syndromes of COVID-19 and general health & well-being.

[0127] Accordingly, the present disclosure provides broad spectrum, highly effective and synergistic composition including one or more standardized Phyto-extracts from one or more plant components, providing a combination of target compounds and % thereof, chosen specifically considering genetics, various possibilities of infection, multiplication, and transmission of SARS-CoV-2, the type and amount of which are carefully calculated to provide therapeutically or prophylactically desired effect of inhibition of cellular entry, multiplication and transmission of SARS-CoV-2 and for management of disorders associated with COVID-19.

[0128] The foregoing description of the specific embodiments will so fully reveal the general nature of the embodiments herein that others can, by applying current knowledge, readily modify and/or adapt for various applications such specific embodiments without departing from the generic concept, and, therefore, such adaptations and modifications should and are intended to be comprehended within the meaning and range of equivalents of the disclosed embodiments. It is to be understood that the phraseology or terminology employed herein is for the purpose of description and not of limitation. Therefore, while the embodiments herein have been described in terms of preferred embodiments, those skilled in the art will recognize that the embodiments herein can be practiced with modification within the spirit and scope of the embodiments as described herein.

ADVANTAGES

[0129] The present disclosure provides a composition that may aid in management of COVID-19 and associated disorders.

[0130] The present disclosure provides a composition for enhancing immunity and general well-being of a subject.

[0131] The present disclosure provides a composition that is substantially devoid of any side effects.

[0132] The present disclosure provides a composition that is easy to prepare and economical.

[0133] Other advantages of the present disclosure will be apparent from the description of the invention provided herein above.