Use of a ginseng herb composition in preparing products for treating COVID-19 and / or alleviating COVID-19 symptoms, related products, and preparation methods thereof

Abstract

The present invention provides a use of a ginseng herb composition in preparing products for treating COVID-19 and / or alleviating COVID-19 symptoms, related products and preparation methods thereof, and belongs to the technical field of traditional Chinese medicine preparations. The raw materials of the ginseng herb composition include the following ingredients: Ganoderma lucidum, medicinal materials of the genus Panax in the Araliaceae family, Cordyceps sinensis, and rose; wherein the medicinal materials of the genus Panax in the Araliaceae family are one or both of ginseng and American ginseng; the Cordyceps sinensis is selected from one or both of fermented Cordyceps sinensis powder and Cordyceps sinensis. Clinical trials have shown that the ginseng herb composition provided by the present invention and the products prepared therefrom can more effectively treat COVID-19 or alleviate COVID-19 symptoms, and have good taste and storage resistance.

Description

Technical Field

[0001] The present invention belongs to the technical field of traditional Chinese medicine preparations, and relates to the use of a ginseng herb composition in preparing products for treating COVID-19 and / or alleviating the symptoms of COVID-19, related products and their preparation methods. Background Art

[0002] According to the World Health Organization (WHO), long COVID refers to symptoms that continue or appear three months after the initial SARS-CoV-2 infection, including fatigue, shortness of breath, and cognitive impairment. Ho et al. pointed out in the article "Long COVID and its management" (Int. J. Biol. Sci. 2022; 18 (12): 4768-4780) that up to 70% of patients who have recovered from COVID-19 infection will experience long-term clinical symptoms. These recurring symptoms may last for weeks or months, seriously reducing the quality of life of patients who have recovered from COVID-19 infection.

[0003] Chinese patent application 202311182546.9 discloses a Cordyceps militaris composition for treating COVID-19 sequelae and its preparation method, which relates to the field of treating COVID-19 sequelae. The composition is made of the following raw materials in parts by weight: 14-23 parts of Cordyceps militaris, 11-16 parts of frost mulberry leaves, 7-14 parts of loquat leaves, 12-15 parts of angelica, 3-6 parts of Cistanche deserticola, 6-9 parts of Astragalus, 3-7 parts of Lilium, 7-11 parts of Ginseng, 11-14 parts of Asarum, 4-9 parts of Scutellaria, 2-4 parts of Schisandra chinensis, and 2-7 parts of Chinese Yam. This composition is added with Cordyceps militaris and frost mulberry leaves, which has the effects of clearing the lungs and moisturizing dryness, resolving phlegm and activating blood circulation, and nourishing qi and yin. The composition can significantly improve the tissue structure of the lungs, effectively treat COVID-19 sequelae, and improve the quality of life of patients.

[0004] Chinese patent application 202310516853.X discloses a traditional Chinese medicine preparation for conditioning body functions after COVID-19 recovery, and a method for preparing its aerosolized liquid. The formula includes ginseng, poria cocos, eucommia leaves, raspberry, patchouli, angelica dahurica, perilla leaves, mulberry leaves, dandelion, and tangerine peel. This formula addresses the needs of patients with yin deficiency, qi deficiency, and deficiency-heat, and can promote rapid recovery by conditioning body functions after COVID-19 recovery. By taking this decoction, combined with lifestyle adjustments, the body strengthens its constitution and improves its immune system, thereby resisting pathogenic factors. This addresses the challenges of preventing progression of the disease and recurrence after recovery.

[0005] Chinese patent application 201210184710.5 discloses a composition for ameliorating chemotherapy-induced toxic and side effects in patients with malignant tumors and its use. The composition comprises 5-200 parts of Ganoderma lucidum, 5-150 parts of American ginseng or Panax ginseng, 1-90 parts of fermented Cordyceps sinensis powder, and / or 1-120 parts of Cordyceps sinensis, or a composition comprising aqueous and / or alcoholic extracts of the aforementioned raw materials as active ingredients, and is used in the preparation of a health supplement, medicine, or product for ameliorating chemotherapy-induced toxic and side effects in patients with malignant tumors. However, this technology does not provide a traditional Chinese medicine composition with improved taste, longer shelf life, and better efficacy against the symptoms of chronic COVID-19. Summary of the Invention

[0006] In view of this, in view of the problem that the existing technology has not yet provided a traditional Chinese medicine composition with better taste, longer storage period, and better efficacy for the symptoms of long-term COVID-19, the purpose of the present invention is to provide a use of a ginseng herb composition in the preparation of treatment for long-term COVID-19 and / or relief of long-term COVID-19 symptoms, related products and their preparation methods.

[0007] To achieve the above-mentioned purpose of the invention, on the one hand, the present invention provides a use of a Shenlingcao composition in preparing a product for treating COVID-19 and / or alleviating the symptoms of COVID-19, wherein the raw materials of the Shenlingcao composition include the following components:

[0008] Ganoderma lucidum, Araliaceae ginseng herbs, cordyceps, rose;

[0009] Wherein, the Araliaceae Panax genus medicinal material is one or both of ginseng and American ginseng;

[0010] The cordyceps is selected from one or both of fermented cordyceps powder and cordyceps sinensis.

[0011] Preferably, the long COVID symptoms include: at least one of: physical and mental fatigue, insomnia, decreased sleep quality, decreased physical function, decreased social function, body pain, anxiety, poor heart rate variability, brain fog, chest pain, and itchy throat.

[0012] Preferably, the raw materials of the ginseng grass composition also include maltitol, cyclodextrin and American ginseng essence.

[0013] Preferably, among the raw materials of the Shenlingcao composition,

[0014] The ganoderma lucidum is one or more of ganoderma lucidum fruiting bodies, ganoderma lucidum decoction pieces, and ganoderma lucidum spore powder;

[0015] The cyclodextrin is at least one of α-cyclodextrin, β-cyclodextrin, and γ-cyclodextrin;

[0016] The cordyceps is fermented cordyceps powder.

[0017] More preferably, among the raw materials of the Shenlingcao composition, the Araliaceae Panax genus medicinal material is a mixture of ginseng and American ginseng; and the cyclodextrin is a mixture of β-cyclodextrin and γ-cyclodextrin.

[0018] More preferably, among the raw materials of the Shenlingcao composition, the American ginseng essence includes the following ingredients:

[0019] Ginseng oil, p-isopropyl-2-methylphenylpropionaldehyde, gamma-nonalactone, ethyl maltol, 3-methylbutyl butyrate, coumarin, Span-80 and glycerin.

[0020] Preferably, the raw materials of the ginseng grass composition include the following components by mass:

[0021] 20-120 parts of Ganoderma lucidum, 10-90 parts of medicinal materials of the genus Panax of the Araliaceae family, 3-90 parts of Cordyceps sinensis, 10-60 parts of rose flowers, 1-80 parts of maltitol, 1-30 parts of cyclodextrin and 0.1-2 parts of American ginseng essence.

[0022] More preferably, the raw materials of the ginseng grass composition include the following components in parts by mass:

[0023] 30-110 parts of ganoderma lucidum, 10-90 parts of medicinal materials of the genus Panax of the Araliaceae family, 25-55 parts of cordyceps, 10-35 parts of rose flowers, 7-19 parts of maltitol, 11-23 parts of cyclodextrin and 0.5-2 parts of American ginseng essence.

[0024] More preferably, the raw materials of the ginseng grass composition include the following components in parts by mass:

[0025] 50-90 parts of ganoderma lucidum, 30-70 parts of medicinal materials of the genus Panax of the Araliaceae family, 35-45 parts of cordyceps, 15-25 parts of rose flowers, 10-16 parts of maltitol, 14-20 parts of cyclodextrin and 0.9-1.6 parts of American ginseng essence.

[0026] Most preferably, the raw materials of the ginseng grass composition include the following components by mass:

[0027] 70 parts of ganoderma lucidum, 50 parts of medicinal materials of the genus Panax of the Araliaceae family, 40 parts of cordyceps, 20 parts of rose flowers, 13 parts of maltitol, 17 parts of cyclodextrin and 1 part of American ginseng essence.

[0028] Further preferably, among the raw materials of the ginseng and herb composition, the Ganoderma lucidum is a mixture of Ganoderma lucidum slices and Ganoderma lucidum spore powder in a mass ratio of 2-4:1-3; the Araliaceae Panax genus medicinal material is a mixture of American ginseng and ginseng in a mass ratio of 1-5:5-9.

[0029] Most preferably, among the raw materials of the ginseng and herb composition, the Ganoderma lucidum is a mixture of Ganoderma lucidum slices and Ganoderma lucidum spore powder in a mass ratio of 3:2; the Araliaceae Panax genus medicinal material is a mixture of American ginseng and ginseng in a mass ratio of 3:7.

[0030] Further preferably, in the raw materials of the ginseng herb composition, the cyclodextrin is a mixture of β-cyclodextrin and γ-cyclodextrin in a mass ratio of 2-3.5:1.5-3.

[0031] Most preferably, among the raw materials of the ginseng herb composition, the cyclodextrin is a mixture of β-cyclodextrin and γ-cyclodextrin in a mass ratio of 2.75:2.25.

[0032] More preferably, among the raw materials of the Shenlingcao composition, the American ginseng essence comprises the following components in parts by mass:

[0033] 35-45 parts of ginseng oil, 3-7 parts of p-isopropyl-2-methylphenylpropionaldehyde, 2-6 parts of γ-nonalactone, 1 part of ethyl maltol, 8-12 parts of 3-methylbutyl butyrate, 4-8 parts of coumarin, 1-5 parts of Span-80 and 3-6 parts of glycerol.

[0034] More preferably, among the raw materials of the Shenlingcao composition, the American ginseng essence includes the following components by mass:

[0035] 40 parts of ginseng oil, 5 parts of p-isopropyl-2-methylphenylpropionaldehyde, 4 parts of γ-nonalactone, 1 part of ethyl maltol, 10 parts of 3-methylbutyl butyrate, 6 parts of coumarin, 3 parts of Span-80 and 5 parts of glycerol.

[0036] The dosage forms of the ginseng herb composition include but are not limited to pills, tablets, powders, granules, oral liquids, lozenges, ointments, and the like.

[0037] More preferably, the ginseng herb composition is ginseng herb oral liquid.

[0038] On the other hand, the present invention provides a ginseng herb composition for the above-mentioned use.

[0039] In another aspect, the present invention provides a method for preparing the Shenlingcao oral liquid described in the above-mentioned use, characterized in that it comprises the following steps:

[0040] (1) Take Ganoderma lucidum, Panax ginseng, Cordyceps sinensis and rose flowers, decoct them 2-3 times with 8-12 times the weight of water, collect the filtrate, concentrate and centrifuge to obtain the supernatant;

[0041] (2) The supernatant obtained in step (1), maltitol, cyclodextrin, American ginseng essence and water are mixed to obtain Shenlingcao oral liquid.

[0042] Preferably, the volume ratio of the total mass of the Ganoderma lucidum, the Araliaceae Panax genus medicinal materials, Cordyceps sinensis and rose flowers in step (1) to the prepared Shenlingcao oral liquid is 0.5-4:20 (g:mL).

[0043] On the other hand, the present invention provides the Shenlingcao oral liquid prepared by the above preparation method.

[0044] Compared with the prior art, the present invention has the following beneficial effects:

[0045] (1) The present invention provides a ginseng herb composition, which can be used to prepare a ginseng herb oral liquid. The ginseng herb oral liquid has a good taste and maintains stable quality during a long storage period.

[0046] (2) The above-mentioned Shenlingcao oral liquid provided by the present invention has the effect of significantly improving the symptoms of COVID-19, including fatigue, insomnia, brain fog, anxiety, itchy throat, chest pain, etc., and can be used as an effective product for treating COVID-19.

[0047] (3) The present invention also provides a method for preparing the above-mentioned Shenlingcao oral liquid. The preparation method is simple and easy to implement and can be easily promoted. DETAILED DESCRIPTION

[0048] The following non-limiting examples are provided to enable those skilled in the art to more fully understand the present invention, but are not intended to limit the present invention in any way. The following are merely illustrative of the scope of the present invention, and those skilled in the art may make various changes and modifications to the present invention based on the disclosed content, which should also fall within the scope of the present invention.

[0049] The present invention will be further described below by way of specific examples. The various chemical reagents used in the examples of the present invention were obtained through conventional commercial channels unless otherwise specified. Unless otherwise specified, the contents described below are all by weight. Unless otherwise specified, it is understood that the experiments were conducted at room temperature.

[0050] In the following examples of the present invention, the fermented Cordyceps sinensis powder used is preferably fermented Cordyceps sinensis powder Cs-4.

[0051] The following Examples 1-5 provide a ginseng herb composition, the components and mass proportions of which are shown in the following table (unit: parts by mass).

[0052]

[0053] The following Examples 6-11 provide a ginseng herb composition, the components and mass proportions of which are shown in the following table (unit: parts by mass).

[0054]

[0055] In Example 1-11, the American ginseng essence is prepared by mixing the following substances in parts by mass:

[0056] 40 parts of ginseng oil, 5 parts of p-isopropyl-2-methylphenylpropionaldehyde, 4 parts of γ-nonalactone, 1 part of ethyl maltol, 10 parts of 3-methylbutyl butyrate, 6 parts of coumarin, 3 parts of Span-80 and 5 parts of glycerol.

[0057] The difference between Example 12 and Example 13 lies in the different material ratios of the American ginseng essence. The types and weight percentages of the remaining ingredients, as well as the total amount of the American ginseng essence used, are the same as those in Example 1. The ingredients and weight percentages of the American ginseng essence in Examples 1, 12, and 13 are shown in the table below (unit: weight percentage).

[0058]

[0059] The following Examples 14-20 provide a ginseng grass composition, the components and mass proportions of which are shown in the following table (unit: mass parts, "-" indicates that the component is not contained).

[0060]

[0061] Similar to Example 1-11, in Example 14-20, the American ginseng essence is prepared by mixing the following substances in parts by mass:

[0062] 40 parts of ginseng oil, 5 parts of p-isopropyl-2-methylphenylpropionaldehyde, 4 parts of γ-nonalactone, 1 part of ethyl maltol, 10 parts of 3-methylbutyl butyrate, 6 parts of coumarin, 3 parts of Span-80 and 5 parts of glycerol.

[0063] Example 21

[0064] Compared with Example 1, the fermented cordyceps powder was replaced with an equal mass of Cordyceps sinensis, and the rest were the same.

[0065] The following Examples 22-23 provide a ginseng grass composition, the components and mass proportions of which are shown in the following table (unit: mass parts, “-” indicates that the component is not contained).

[0066]

[0067] Similar to Example 1-11, in Example 22-23, the American ginseng essence is mixed by the following substances in parts by mass:

[0068] 40 parts of ginseng oil, 5 parts of p-isopropyl-2-methylphenylpropionaldehyde, 4 parts of γ-nonalactone, 1 part of ethyl maltol, 10 parts of 3-methylbutyl butyrate, 6 parts of coumarin, 3 parts of Span-80 and 5 parts of glycerol.

[0069] Preparation Example 1

[0070] Preparation method of Shenlingcao oral liquid:

[0071] Ganoderma lucidum, Araliaceae Panax ginseng herbs, fermented Cordyceps sinensis powder / Cordyceps sinensis, and rose flowers are ground using a traditional Chinese medicine grinder, decocted three times with 10 times the weight of water, filtered, and the filtrate collected after each decoction is concentrated to a density of 1.02-1.05. The filtrate is centrifuged at 5000 rpm for 2 minutes, and the supernatant is collected. The resulting supernatant is mixed with the formulated amount of maltitol, cyclodextrin, and American ginseng essence, and an appropriate amount of purified water is added such that the total mass of Ganoderma lucidum, Araliaceae Panax ginseng herbs, fermented Cordyceps sinensis powder, and rose flowers to the volume of the Shenlingcao oral liquid is 1:20 (g:mL). The resulting Shenlingcao oral liquid is then canned into appropriate volumes and pasteurized to form the Shenlingcao oral liquid product.

[0072] By adopting the above method, the Shenlingcao oral liquid can be prepared according to the Shenlingcao compositions provided in Examples 1-23, which are named oral liquids 1-23 respectively.

[0073] Comparative Example 1

[0074] Compared with Example 1, the cyclodextrin used was replaced with maltodextrin (DE value 16.5-19.5) of equal mass, and the rest were the same.

[0075] Comparative Example 2

[0076] Compared with Example 1, the rose flowers used were changed to Roselle flowers of equal mass, and the rest were the same.

[0077] Comparative Example 3

[0078] Compared with Example 1, the American ginseng essence used was replaced by the American ginseng essence provided in Example 1 of Chinese patent application 201710287898.9 of equal quality, and the rest were the same.

[0079] Specifically, the American ginseng essence is composed of the following components in percentage by mass:

[0080] 10% American ginseng extract (ethanol reflux extraction), 1% diacetyl, 0.3% linalool, 0.5% methyl cinnamate, 0.2% myrcene, 1% clove oil, 87% caprylic / capric glyceride.

[0081] Comparative Example 4

[0082] Compared with Example 1, the medicinal material of the genus Panax in the Araliaceae family was changed to Pseudostellaria chinensis of equal quality, and the rest were the same.

[0083] Comparative Example 5

[0084] Compared with Example 1, the maltitol used was replaced with an equal mass of mannose, and the rest were the same.

[0085] Preparation Example 2

[0086] Preparation method of Shenlingcao oral liquid:

[0087] The formulated amount of Ganoderma lucidum, Panax ginseng (Pseudostellaria spp. in Comparative Example 4), fermented Cordyceps sinensis powder, and rose (Roselle spp. in Comparative Example 2) were pulverized using a traditional Chinese medicine grinder, decocted three times with 10 times the mass of water, filtered, and the filtrate from each decoction collected and concentrated to a density of 1.02-1.05. The filtrate was centrifuged at 5000 rpm for 2 minutes, and the supernatant was collected. The resulting supernatant was mixed with the formulated amount of maltitol (lactitol in Comparative Example 5), cyclodextrin (dextrin in Comparative Example 1), and American ginseng essence. An appropriate amount of purified water was added such that the total mass of Ganoderma lucidum, Panax ginseng (Pseudostellaria spp. in Comparative Example 4), fermented Cordyceps sinensis powder, and rose (Roselle spp. in Comparative Example 2) to the volume of the Shenlingcao oral liquid was 1:20 (g:mL). The resulting Shenlingcao oral liquid was then canned in appropriate volumes and pasteurized to form the Shenlingcao oral liquid product.

[0088] By adopting the above method, the Shenlingcao oral liquid can be prepared according to the Shenlingcao compositions provided in Comparative Examples 1-5, which are named oral liquids C1-C5 respectively.

[0089] Effect evaluation

[0090] 1. Sensory evaluation of Shenlingcao oral liquid after being placed at 0℃, 25℃ and 45℃ for 1 day, 20 days and 40 days respectively.

[0091] Oral liquids 1-23 obtained in Preparation Example 1 and oral liquids C1-C5 obtained in Preparation Example 2 were stored at 0°C, 25°C, and 45°C for 1 day, 20 days, and 40 days, respectively, before undergoing sensory evaluation testing. Ten trained volunteers aged 25-50 were selected and asked to taste oral liquids 1-23 obtained in Preparation Example 1 and oral liquids C1-C5 obtained in Preparation Example 2. The oral liquids were then scored on a scale of 0-10 for appearance, taste, and mouthfeel. The sensory evaluation results were then averaged. The specific scoring criteria are shown in the following table:

[0092]

[0093] The appearance evaluation scores of Shenlingcao oral liquid after being placed at 25°C for 1 day, 20 days and 40 days are shown in the following table:

[0094]

[0095] The appearance evaluation scores of Shenlingcao oral liquid after being placed at 0°C for 1 day, 20 days and 40 days are shown in the following table:

[0096]

[0097] The appearance evaluation scores of Shenlingcao oral liquid after being placed at 40°C for 1 day, 20 days and 40 days are shown in the following table:

[0098]

[0099] It can be seen that the appearance evaluation scores of the oral liquid 1-23 obtained in Preparation Example 1 after storage at 0°C, 25°C, and 40°C for 1 day, 20 days, and 40 days, respectively, are generally higher than the appearance evaluation scores of the oral liquids C1 and C5 obtained in Preparation Example 2. Specifically, in oral liquid C1, maltodextrin is used to replace cyclodextrin, and in oral liquid C5, mannose is used to replace maltitol. The appearance scores of the oral liquids C1 and C5 after storage at 0°C, 25°C, and 40°C for 40 days are significantly lower than those of oral liquids 1-23. This shows that the types of the two excipients, cyclodextrin and maltitol, play an important role in the appearance stability of the Shenlingcao oral liquid, and it cannot be achieved by arbitrarily selecting the types of excipients.

[0100] The taste evaluation scores of Shenlingcao oral liquid after being stored at 25°C for 1 day, 20 days and 40 days are shown in the following table:

[0101]

[0102] The taste evaluation scores of Shenlingcao oral liquid after being stored at 0°C for 1 day, 20 days and 40 days are shown in the following table:

[0103]

[0104] The taste evaluation scores of Shenlingcao oral liquid after being placed at 40°C for 1 day, 20 days and 40 days are shown in the following table:

[0105]

[0106] As can be seen, the taste evaluation scores of oral liquids 1-23 obtained in Preparation Example 1 after storage at 0°C, 25°C, and 40°C for 1 day, 20 days, and 40 days, respectively, were generally higher than those of oral liquids C1-C5 obtained in Preparation Example 2. Specifically, in oral liquid C1, maltodextrin was used instead of cyclodextrin; in oral liquid C2, roselle was used instead of rose; in oral liquid C3, different flavorings provided by different existing technologies were used; in oral liquid C4, Pseudostellaria sibiricum was used instead of Panax ginseng; and in oral liquid C5, mannose was used instead of maltitol. After storage at 0°C, 25°C, and 40°C for 40 days, the taste scores of oral liquids C1-C5 were all lower than those of oral liquids 1-23. This shows that the use of Araliaceae Panax genus medicinal materials, rose flowers, and the types of cyclodextrin, maltitol and Pseudostellaria heterophylla essence in the Shenlingcao oral liquid provided by the present invention all have a significant effect on improving the taste evaluation of the Shenlingcao oral liquid, and this effect on improving the taste cannot be achieved by arbitrarily selecting the main ingredients or auxiliary ingredients.

[0107] The taste evaluation scores of Shenlingcao oral liquid after being stored at 25°C for 1 day, 20 days and 40 days are shown in the following table:

[0108]

[0109] The taste evaluation scores of Shenlingcao oral liquid after being placed at 0°C for 1 day, 20 days and 40 days are shown in the following table:

[0110]

[0111] The taste evaluation scores of Shenlingcao oral liquid after being placed at 40°C for 1 day, 20 days and 40 days are shown in the following table:

[0112]

[0113] It can be seen that the taste evaluation scores of the oral liquid 1-23 obtained in Preparation Example 1 after storage at 0°C, 25°C, and 40°C for 1 day, 20 days, and 40 days, respectively, are generally higher than the taste evaluation scores of the oral liquids C1 and C5 obtained in Preparation Example 2. Specifically, in oral liquid C1, maltodextrin is used to replace cyclodextrin, and in oral liquid C5, mannose is used to replace maltitol. The taste scores after storage at 0°C, 25°C, and 40°C for 40 days are significantly lower than those of oral liquid 1-23. This shows that the types of the two excipients, cyclodextrin and maltitol, play an important role in the taste stability of the Shenlingcao oral liquid, and it cannot be achieved by arbitrarily selecting the types of excipients.

[0114] 2. Experiment on using Shenlingcao oral liquid to improve the clinical symptoms of patients with COVID-19.

[0115] 2.1 Case selection

[0116] Inclusion criteria:

[0117] Adults aged 18-65 years; meet the diagnostic criteria for long COVID-19 published by the Centers for Disease Control and Prevention (CDC) in 2022: have been infected with SARS-CoV-2 and symptoms have persisted for more than 4 weeks (calculated from the date of the first positive PCR / rapid test result); the Chalder Fatigue Scale binary score (0-11 points) is not less than 4 points.

[0118] Exclusion criteria:

[0119] (1) Suffering from diseases that may cause chronic fatigue before contracting Covid-19, including but not limited to:

[0120] a. Cardiovascular and cerebrovascular diseases, such as arrhythmia, heart failure, myocardial infarction and stroke.

[0121] b. Chronic lung diseases, such as chronic obstructive pulmonary disease and moderate to severe asthma.

[0122] c. Sleep apnea syndrome and narcolepsy.

[0123] d. Cognitive impairment, such as Alzheimer's disease and vascular dementia.

[0124] e. Have serious mental illnesses, such as severe depression, schizophrenia, and anorexia nervosa.

[0125] f. Untreated hypothyroidism.

[0126] g. Chronic liver and kidney diseases.

[0127] h. Tumor.

[0128] i. Immune deficiency.

[0129] (2) The patient is currently taking or needs to continue taking long-term drugs that may affect the test results (including but not limited to: antibiotics, hormone drugs, analgesics, psychotropic drugs, intestinal flora regulating drugs, etc.).

[0130] (3) Severely obese people (body mass index BMI not less than 45).

[0131] (4) Alcohol or other drug addicts.

[0132] (5) Those who are allergic to Chinese medicine.

[0133] (6) Pregnant women, breastfeeding women and women preparing to become pregnant.

[0134] Rejection criteria:

[0135] (1) Those who are found to not meet the inclusion criteria or meet the exclusion criteria after inclusion.

[0136] (2) Those who could not be contacted more than 30 days after randomization.

[0137] (3) Unauthorized use / acceptance of other therapeutic drugs or treatments that may affect the observed indicators.

[0138] 2.2 Treatment options

[0139] Experimental samples:

[0140] The oral solution 1 obtained in Preparation Example 1 was designated as "Oral Solution Group 1".

[0141] "Placebo Group". The composition of the solution used in the placebo group:

[0142] Each 100 mL of the placebo group solution contained 5 g of maltitol, 3.5 g of maltodextrin, 3 g of sucrose octaacetate, 1 g of caramel pigment, 1 g of American ginseng essence, and the remainder of purified water; the American ginseng essence was the same as the American ginseng essence used in Example 1.

[0143] Grouping:

[0144] Simple randomization was used. An independent researcher generated a random sequence using Random Allocation Software 2.0. Participants were randomly assigned to either the oral solution group 1 or the placebo group (a total of 152 participants, 76 in each group). The grouping sequence was stored in a light-proof, sealed envelope in the care of the study leader. The drug manufacturer generated a label based on the sequence and affixed it to the corresponding study drug. Each patient was assigned a specific number. Participants, researchers, and data analysts were unaware of the grouping until the end of the study.

[0145] Directions:

[0146] After a 2-week screening period, each group was given oral solution for a 4-week treatment period and a 4-week follow-up period. The dosage was 200 mL, twice daily, with one bottle administered each time.

[0147] Treatment course:

[0148] The intervention period was 28 days, and the follow-up period was 28 days, for a total of 56 days.

[0149] 2.3 Observation items

[0150] 1. Primary outcome measure: Chalder Fatigue Scale

[0151] Changes in the Chalder Fatigue Scale (CFS-33) score (0-33 points) after four weeks of treatment compared with baseline.

[0152] The Chalder Fatigue Scale consists of 11 items, covering both physical (7 items) and mental (4 items) fatigue. It is assessed using a 4-point Likert-type rating scale: 0 indicates less fatigue than before, 1 indicates the same symptoms as before, 2 indicates slightly worse symptoms than before, and 3 indicates much worse symptoms than before. The total score is 33. Higher scores indicate more severe fatigue.

[0153] The specific contents of the Chalder Fatigue Scale are shown in the following table:

[0154]

[0155] 2. Secondary outcome measures

[0156] (1) Changes in the Insomnia Severity Index (ISI) scores after four weeks of treatment and four weeks of follow-up compared with baseline scores.

[0157] The specific contents of the Insomnia Severity Scale are shown in the following table:

[0158]

[0159] (2) SF-36 quality of life score

[0160] Changes in the SF-36 quality of life score compared with baseline scores after four weeks of treatment and four weeks of follow-up.

[0161] The SF-36 scoring system consists of 36 questions, of which the second question is not included in the scoring, and 35 questions are condensed into 8 multi-item scales. (1) Physical function is a 10-item scale that covers the ability to deal with the physical demands of life, such as meeting personal needs, walking, and flexibility; (2) Role-physical is a four-item scale that assesses the extent to which physical abilities limit activities; (3) Bodily pain is a two-item scale that assesses the amount of pain perceived in the past 4 weeks and the degree to which pain interferes with normal work activities; (4) General health is a five-item scale that assesses general health; (5) Vitality is a four-item scale that assesses feelings of spirit, energy, and fatigue; (6) Social functioning (SF) is a two-item scale that assesses the extent and amount of time (if any) that physical health or emotional problems interfered with family, friends, and other social interactions in the past 4 weeks; (7) Role-emotional (RE) is a three-item scale that assesses the extent to which emotional factors interfered with work or other activities (if any); and (8) Mental health is a five-item scale that primarily assesses feelings of anxiety and depression.

[0162] The specific content of the SF-36 quality of life rating scale is shown in the following table:

[0163]

[0164] (3) Anxiety and Depression Scale

[0165] Changes in the Hospital Anxiety and Depression Scale (HADS) scores after four weeks of treatment and a four-week follow-up period compared with baseline.

[0166] The specific content of the HADS is shown in the following table:

[0167]

[0168] (4) Self-assessment of COVID-19 symptoms

[0169] Changes in long-term COVID-19 symptom scores after four weeks of treatment and follow-up compared to baseline scores. The survey included three items: brain fog (difficulty thinking or concentrating), itchy throat, and chest pain.

[0170] The specific contents of the self-assessment form are shown in the following table:

[0171]

[0172] (5) Exploratory indicators: The last 20 individuals in the oral solution group 1 and the placebo group were selected as research subjects. Heart rate and sleep indicators (including total sleep time, light sleep time, deep sleep time, and heart rate variability) were collected using wearable devices. The tests were performed in weeks 1-4 of the intervention period and weeks 1-4 of the subsequent follow-up period. The rate of change in total sleep time compared with baseline was calculated.

[0173] 2.4 Clinical Outcomes

[0174] The results of the clinical experiments recorded in 2.3 (Chalder Fatigue Scale, Insomnia Severity Scale, Quality of Life Score SF-36, Anxiety and Depression Scale HADS, and Assessment of Self-Symptoms of Long-term COVID-19 (including itchy throat, chest pain, and brain fog)) are summarized as shown in the following table:

[0175]

[0176] From the experimental results in the above table, it can be seen that for the symptoms of COVID-19, such as fatigue, insomnia, anxiety, decreased physical function, decreased social function, body pain, brain fog, itchy throat, chest pain, etc., the improvement effect brought by the oral liquid 1 group was significantly better than that of the placebo group, and the p values were all less than 0.05.

[0177] Summarize the experimental results of using wearable devices to collect heart rate and sleep indicators (including total sleep time, light sleep time, deep sleep time and heart rate variability) recorded in 2.3.

[0178] The change rate of total sleep duration compared with the baseline is shown in the following table:

[0179]

[0180] The rate of change in light sleep duration compared to baseline is shown in the following table:

[0181]

[0182] The rate of change of deep sleep duration compared to baseline is shown in the following table:

[0183]

[0184] It can be seen that Shenlingcao oral liquid has the effect of significantly prolonging sleep time and improving sleep quality.

[0185] The effects of oral solution 1 and placebo on heart rate variability are shown in the following table:

[0186]

[0187] It can be seen that the oral solution 1 group had a significant effect of improving heart rate variability compared with the placebo group.

[0188] Finally, it should be noted that the above content is only used to illustrate the technical solution of the present invention, rather than to limit the scope of protection of the present invention. Simple modifications or equivalent substitutions of the technical solution of the present invention by ordinary technicians in this field do not deviate from the essence and scope of the technical solution of the present invention.

Claims

1. A use of a ginseng herb composition in preparing a medicament for treating COVID-19, characterized in that: The Shenlingcao composition is a Shenlingcao oral liquid; The raw materials of the ginseng grass composition are composed of the following components by mass: 50-90 parts of Ganoderma lucidum, 30-70 parts of Panax genus of the Araliaceae family, 35-45 parts of Cordyceps sinensis, 15-25 parts of rose flowers, 10-16 parts of maltitol, 14-20 parts of cyclodextrin, and 0.9-1.6 parts of American ginseng essence; Wherein, the medicinal materials of the genus Panax of the Araliaceae family are ginseng and American ginseng; The cordyceps is fermented cordyceps powder; The ganoderma lucidum is ganoderma lucidum decoction pieces and ganoderma lucidum spore The cyclodextrin is a mixture of β-cyclodextrin and γ-cyclodextrin in a mass ratio of 2.75:2.25; The American ginseng essence is made from the following ingredients in parts by mass: 35-45 parts of ginseng oil, 3-7 parts of p-isopropyl-2-methylphenylpropionaldehyde, 2-6 parts of γ-nonalactone, 1 part of ethyl maltol, 8-12 parts of 3-methylbutyl butyrate, 4-8 parts of coumarin, 1-5 parts of Span-80 and 3-6 parts of glycerol.

2. The use according to claim 1, characterized in that Among the raw materials of the ginseng and herb composition, the Ganoderma lucidum is a mixture of Ganoderma lucidum slices and Ganoderma lucidum spore powder in a mass ratio of 2-4:1-3; the Araliaceae Panax genus medicinal material is a mixture of American ginseng and ginseng in a mass ratio of 1-5:5-9.

3. The use according to claim 1, characterized in that Among the raw materials of the Shenlingcao composition, the American ginseng essence is made of the following ingredients in parts by mass: 40 parts of ginseng oil, 5 parts of p-isopropyl-2-methylphenylpropionaldehyde, 4 parts of γ-nonalactone, 1 part of ethyl maltol, 10 parts of 3-methylbutyl butyrate, 6 parts of coumarin, 3 parts of Span-80 and 5 parts of glycerol.

4. The ginseng herb composition for use according to any one of claims 1 to 3.

5. The method for preparing the Shenlingcao oral liquid for use according to any one of claims 1 to 3, characterized in that: The following steps are involved: (1) Take Ganoderma lucidum, Panax ginseng, Cordyceps sinensis and rose flowers, decoct them 2-3 times with 8-12 times the weight of water, collect the filtrate, concentrate and centrifuge to obtain the supernatant; (2) The supernatant obtained in step (1), maltitol, cyclodextrin, American ginseng essence and water are mixed to obtain Shenlingcao oral liquid.

6. The preparation method according to claim 5, characterized in that The volume ratio of the total mass of the Ganoderma lucidum, the Araliaceae Panax genus medicinal materials, Cordyceps sinensis and rose flowers described in step (1) to the prepared Shenlingcao oral liquid is 0.5-4:20 (g:mL).

7. Shenlingcao oral liquid prepared by the preparation method according to any one of claims 5-6.

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