Medicated diet composition for treating heat cough, and preparation method therefor and use thereof

Abstract

A medicated diet composition for treating a heat cough, prepared from the raw materials in the following parts by mass: 50-100 parts of kumquat, 30-50 parts of Eleocharis dulcis, 5-10 parts of Glehniae radix and 5-10 parts of Platycodonis radix. The medicated diet composition can improve the symptoms of a heat cough of a SARS-CoV-2 infection.

Description

TECHNICAL FIELD

[0001] The present disclosure belongs to the technical field of traditional Chinese medicine, and particularly relates to a medicated diet composition for treating a heat cough, and a preparation method therefor and use thereof. BACKGROUND

[0002] Cough is a common symptom after infection with the severe acute respiratory syndrome coronavirus 2 (S \RS Ca>\' 2). Traditional Chinese medicine (TCM) has demonstrated unique advantages in treating a cough after SARS-CoV-2 infection, for which a variety of TCM products have already been developed. However, compared with urban areas, rural areas often face shortages in epidemic prevention medicine, limited medical resources, and greater difficulties in obtaining medicine. As a result, patients infected with SARS-CoV-2 in rural areas are more likely to experience disease progression due to failure to receive timely and effective treatment. According to the TCM theory, food and medicine share a common origin, and diet is considered as important as medicine. In treating diseases, TCM practitioners throughout history have placed great emphasis on dietary regulation alongside medical treatment. TCM-based dietary therapy has profound cultural and historical foundations. Therefore, in areas with relatively scarce pharmaceuticals and medical resources, and difficulties in obtaining medicine, dietary therapy utilizing locally available medicinal herbs and food ingredients may be used to alleviate symptoms such as cough following SARS-CoV-2 infection. Nevertheless, there remains a lack of medicated diet compositions that are readily accessible and have good therapeutical effects. SUMMARY

[0003] A first objective of the present disclosure is to provide a medicated diet composition for treating a heat cough, a second objective of the present disclosure is to provide a preparation method for the medicated diet composition, and a third objective of the present disclosure is to provide use of the medicated diet composition.

[0004] According to a first aspect of the present disclosure, a medicated diet composition for treating a heat cough is provided, and the medicated diet composition includes the following raw materials in parts by mass: 50-100 parts of kumquat, 30-50 parts of Eleocharis dulcis, 5-10 parts of Glehniae radix, and 5-10 parts of Platycodonis radix.

[0005] The present disclosure is aimed at a heat cough caused by SARS-CoV-2 infection, which is mainly manifested as cough with sore throat, bitterness in mouth, coughing up yellow phlegm, fever or restless fever, red or reddish tongue with yellow coating, and floating and rapid pulse, etc.

[0006] In the formula, the kumquat is warm in nature, pungent and sweet in taste, and is capable of regulating qi and releasing stagnation, aiding digestion and resolving phlegm. The Eleocharis dulcis is sweet and cold in nature, and is capable of clearing heat and producing fluid, resolving phlegm, and dissipating food accumulation. The kumquat and the Eleocharis dulcis are used together to play the effects of clearing heat and resolving, regulating qi, and relieving cough, and serve as sovereign herbs together. The Glehniae radix is sweet and cool in nature, and is capable of enriching and tonifying lungjo, clearing lung heat, resolving phlegm and stopping cough. It assists the sovereign herbs to clear lung heat and resolve phlegm heat, and serves as minister herb. The Platycodonis radix is effective in diffusing and promoting lung qi, relieving cough, and resolving phlegm, and guides other herbs into the lung meridian. It serves as assistant and envoy herb. The herbs are combined together to have efficacy of clearing heat and resolving phlegm, regulating qi and relieving cough, thereby rapidly improving symptoms of heat cough caused by the SARS-CoV-2 infection.

[0007] Raw materials of the formula are as follows:

[0008] Kumquat: Fruit of Fortunella margarita (Lour.) Swingle.

[0009] Eleocharis dulcis: Bulb of Eleocharis dulcis (Burm.f.) Trin. ex Henschel (E. tuberosa Roem et Scheldt.; E. plantaginea R. Brown.], plant of family Cyperaceae Eleocharis.

[0010] Glehniae radix-. Dried root of GAhnia littoralis Fr. Schmidt ex Miq., plant of family Apiaceae.

[0011] Platycodonis radix: Dried root of Platycodon grandiflorum (Jacq.) A.DC., plant of family Campanulaceae.

[0012] In some embodiments, raw materials of the medicated diet composition for treating a heat cough include, in parts by mass: 100 parts of kumquat, 50 parts of Eleocharis dulcis, 10 parts of Glehniae radix and 10 parts of Platycodonis radix.

[0013] In some embodiments, raw materials of the medicated diet composition for treating a heat cough include, in parts by mass: 50 parts of kumquat, 30 parts of Eleocharis dulcis, 5 parts of Glehniae radix and 5 parts of Platycodonis radix.

[0014] In some embodiments, raw’ materials of the medicated diet composition for treating a heat cough further include food-grade seasonings or pharmaceutically acceptable excipients.

[0015] According to a second aspect of the present disclosure, a preparation method for the medicated diet composition for treating a heat cough is provided, including the following steps:

[0016] chopping Eleocharis dulcis into pieces, keeping kumquat whole, mixing the chopped Eleocharis dulcis smth the kumquat, Eleocharis dulcis, and Platycodonis radix to obtain a mixture, adding water in an amount of 2-5 times a weight of the raw materials to the mixture, and decocting for 30-60 min to obtain the medicated diet composition.

[0017] When preparing the medicated diet composition in the present disclosure, the kumquat is kept whole, such that effective ingredients in peel and pulp of the kumquat can be extracted more effectively, which cannot only make the medicated diet taste sweet and sour, but also focus on relieving cough and resolving phlegm, as well as improve synergistic effects with the other ingredients for clearing heat, resolving phlegm, regulating qi, and relieving cough.

[0018] According to a third aspect of the present disclosure, use of the medicated diet composition for treating a heat cough in preparing medicine for treating SARS-CoV-2 infection is provided.

[0019] According to a fourth aspect of the present disclosure, use of the medicated diet composition for treating a heat cough in preparing medicine for treating a cough caused by SARS-CoV-2 infection accompanied by sore throat or cough up yellow sputum is provided.

[0020] Compared with the prior art, the present disclosure has the following beneficial effects:

[0021] (1) The medicated diet composition of the present disclosure can rapidly improve symptoms of heat cough caused by SARS-CoV-2 infection, especially suitable for patients with the heat cough caused by SARS-CoV-2 infection in areas with relatively scarce pharmaceutical resources, limited medical facilities, or difficulties in obtaining medicine.

[0022] (2) The present disclosure selects four ingredients that are both foods and TCM herbs to form the medicated diet composition. Common food kumquat and Eleocharis dulcis are selected as sovereign herbs, combined with Glehniae radix and Platycodonis radix that are edible Chinese medicinal materials, common and easily accessible, economical, and palatable ingredients, to provide a feasible medication option for patients with the heat cough after SARS-CoV-2 infection. BRIEF DESCRIPTION OF THE DRAWINGS

[0023] FIG. 1 is a graph showing survival curves of two groups after propensity score matching (PSM) in clinical trials of the present disclosure. DETAILED DESCRIPTIONS OF THE EMBODIMENTS

[0024] The present disclosure is further described below in conjunction with the following specific examples. It is worth noting that the following examples are intended solely to better explain the content of the present disclosure and should not be construed as limiting the scope of protection of the present disclosure. Any process steps not disclosed in the examples are the prior art. Unless otherwise specified, all raw materials used in the following examples are commercially available.

[0025] Example 1

[0026] A medicated diet for treating a heat cough in this example was composed of the following raw materials in parts by mass: 100 g kumquat, 50 g Eleocharis dulds, 10 g Glehniae radix and 10 g Platycodonis radix.

[0027] A preparation method for medicated diet included the following steps:

[0028] The Eleocharis dulds was chopped into pieces, the kumquat was kept whole, the chopped Eleocharis dulds was mixed with kumquat, Eleocharis dulds, and Platycodonis radix to obtain a mixture, 500 mL of waterwas added to the mixture, and the mixture was decocted for 40 min until a volume was reduced to approximately 200 mL. The resulting decoction was the medicated diet for treating a heat cough.

[0029] The medicated diet in this example is suitable for adult patients with the heat cough caused by SARS-CoV-2 infection. A dosage of one dose was 200 mL, and one dose was divided into 3-4 servings for taking daily.

[0030] Example 2

[0031] A medicated diet for treating a heat cough in this example was composed of the following raw materials in parts by mass: 50g kumquat, 30g Eleocharis dulds, 5g Glehniae radix and 5g Platycodonis radix.

[0032] A preparation method for the medicated diet included the following steps:

[0033] The Eleocharis dulds was chopped into pieces, the kumquat was kept whole, the chopped Eleocharis dulds \nx& mixed with kumquat, Eleocharis dulds, and Platycodonis radix to obtain a mixture, 300 mL of waterwas added to the mixture, and the mixture was decocted for 40 min until a volume was reduced to approximately 150 mL. The resulting decoction was the medicated diet for treating a heat cough.

[0034] The medicated diet in this example is suitable for children patients with the heat cough caused by SARS-CoV-2 infection. A dosage of one dose was 150 mL, and one dose was divided into 3-4 servings for taking daily.

[0035] In order to evaluate the therapeutic effect of the medicated diet compositions of the present disclosure on a heat cough caused by SARS-CoV-2 infection, the medicated diets prepared in Examples 1-2 were used for clinical trials.

[0036] I. Related criteria

[0037] (I) Diagnostic criteria

[0038] 1. Western medicine disease diagnosis

[0039] According to the Diagnosis and Treatment Protocolfor Novel Coronavirus Pneumonia (Trial Version 9), a confirmed diagnosis requires epidemiological history and clinical manifestations, along with etiological evidence (that is, positive for SARS-CoV-2 nucleic acid test or antigen test).

[0040] Clinically classified as mild case and moderate case in accordance with the Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (Trial Version 9).

[0041] 2. Diagnostic criteria for TCM syndromes

[0042] Heat cough: Cough with sore throat, bitterness in mouth, coughing up yellow phlegm, fever or restless fever, red or reddish tongue with yellow coating, and floating and rapid pulse.

[0043] Cold cough: Cough with itchy throat, coughing up white phlegm, aversion to cold, white or greasy tongue coating, floating and tight pulse, accompanied by headache, clear nasal discharge, and cold pain in limbs.

[0044] (II) Inclusion criteria

[0045] 1. Patients who were positive for SARS-CoV-2 by nucleic acid test or antigen test;

[0046] 2. Patients who were clinically classified as mild case or moderate case in accordance with the diagnosis criteria specified in the Diagnosis and Treatment Protocolfor Novel Coronavirus Pneumonia (Trial Version 9).

[0047] 3. Patients whose primary symptom was cough;

[0048] 4. Patients who or whose legal representatives have signed the informed consent.

[0049] (III) Exclusion criteria

[0050] 1. Individuals with allergic constitution or those allergic to the raw materials of the medicated diet composition of the present disclosure;

[0051] 2. Individuals who suffer from chronic pulmonary diseases that may interfere with the assessment of cough symptoms, such as bronchiectasis, bronchopneumonia, chronic pulmonary abscess, chronic cough lasting more than 8 weeks, chronic pharyngitis with cough, lung cancer, and bacterial respiratory tract infections;

[0052] 3. Heavy smokers (defined as years of smoking x cigarettes smoked per day >400, for example, years of smoking >20 years, and >20 cigarettes per day);

[0053] 4. Individuals who are unable to comply with follow-up visits;

[0054] 5. Pregnant female subjects;

[0055] 6. Individuals with severe underlying diseases or with acute exacerbation of chronic diseases, such as acute heart failure; and

[0056] 7. Individuals who have participated in any other clinical trial over the past one month or are participating in any other clinical trial at present.

[0057] II. Case sources and grouping

[0058] Cases were from patients confirmed to have infected with SARS-CoV-2 in Yangshuo Town, Baisha Town, Fuli Town, Gaotian Town, and Puyi Township of Yangshuo County, Guangxi Province, PR.China.

[0059] The experiment was designed based on a real-world observational study, with an experimental group : control group = 2:1. A two-sided test, with a = 0.05 and [3 = 0.10, that is, a power of 90% at a 0.05 significance level, was performed to calculate a required sample size. Accordingly, 483 cases were required in the experimental group, 242 cases were required in the control group. Considering a 15% lost to follow-up rate, 555 cases were required in the experimental group, and 278 cases were required in the control group, totaling up to 833 cases.

[0060] III. Observation indicators and time points

[0061] (1) General Information, including age, gender, height, weight, medical history, time of disease onset, whether novel coronavirus (COVID-19) vaccine was received, and smoking history, etc. was collected at a first observation.

[0062] (2) Clinical symptoms and signs: including fever, cough, shortness of breath, sore throat, diarrhea, nasal congestion or runny nose, fatigue, poor appetite, headache, muscle pain, chest tightness, chest pain, hypogeusia, and hyposmia, was collected daily during a treatment period.

[0063] (3) Cough Evaluation Test Table, as shown in Table 1, collected daily during the treatment period. The treatment period lasted for 5 days. Patients whose cough symptoms disappear within the first 5 days ended the follow-up on Days 6 and 7.

[0064] Table 1 Cough Evaluation Test Please read through the following questions and check (V) an appropriate box according to your current cough situation: None 1 Rarely 2 Occasionally 3 Often 4 Frequent 5 1. Do you have a cough in the daytime? (Daytime refers to a period from waking up in the morning until going to bed at night.) 1 2 3 4 5 2. Does coughing affect your sleep? 1 2 3 4 5 3. Do you experience severe coughing? 1 2 3 4 5 4. Does coughing affect your work, study, or daily activities? 1 2 3 4 5 5. Do you feel anxious because of coughing? 1 2 3 4 5

[0065] (4) Treatment protocol, including whether any other medications were used in combination for the treatment of SARS-CoV-2 infection or for symptomatic relief.

[0066] (5) Post-medication status, information was collected daily during the treatment period.

[0067] IV. Treatment protocol

[0068] 1. Conventional treatment protocol: treatment was conducted in accordance with the Diagnosis and TreatmentProtocolfor Novel Coronavirus Pneumonia (Trial Version 9), including symptomatic treatments such as antipyretics, analgesics, and anti-vomiting.

[0069] 2. TCM syndrome differentiation and treatment protocol:

[0070] (1) Cold cough: Adults: 100 g kumquat, 20 g fresh ginger, 3 g Citri reticulataepericarpium, and 10g Platycodonis radix were taken, 500 mL water was added and decocted for 40 min until a volume was reduced to approximately 200 mL. A dosage of one dose was 200 mL, and one dose was divided into 3-4 servings for taking daily. Children: 50 g kumquat, 10 g fresh ginger, 2 g Citri reticulataepericarpium, and 5 g Platycodonis radix were taken, 300 mL water was added and decocted for 40 min until a volume was reduced to approximately 150 mL. A dosage of one dose was 150 mL, and one dose was divided into 3-4 servings for taking daily. A treatment period was 5 days.

[0071] (2) Heat cough: Adult patients were administered the medicated diet prepared in Example 1; and a dosage of one dose was 200 mL, and one dose was divided into 3-4 servings for taking daily. Children patients were administered the medicated diet prepared in Example 2, and a dosage of one dose was 150 mL, and one dose was divided into 3-4 servings for taking daily. A treatment period was 5 days.

[0072] Patients who received the TCM syndrome differentiation and treatment protocol were, in principle, not permitted to take other TCM medications of relieving cough and resolving phlegm.

[0073] Patients in the control group received the conventional treatment protocol, and patients in the experimental group received the TCM syndrome differentiation and treatment protocol. Patients were assigned to the control group or the experimental group according to the actual treatment protocol received by the patients, and therapeutic indicators were compared between the control group and the experimental group. Time for the disappearance of cough symptoms was used as a primary efficacy indicator.

[0074] V. Statistical methods

[0075] All data were analyzed using SPSS and R. Normally distributed data were expressed as “mean + standard deviation”, and t-test or analysis of variance were used for comparison between the groups. Non-normally distributed data were tested using non-parametric tests. Categorical variables were expressed as counts and percentages, and an / 2 test or an exact test was adopted for comparison between the groups. The time of cough symptom disappearance between the two groups was compared using propensity score matching and Cox regression analysis. Propensity score matching was performed using nearest-neighbor matching, with a caliper value of 0.2. P <0.05 indicated that a difference was statistically significant.

[0076] VI. Experimental results

[0077] A total of 1,434 patients were followed up. After excluding patients who had no cough symptoms at baseline (627 cases), patients with chronic pulmonary disease (13 cases) and heavy smokers (30 cases), 763 cases were included in the analysis: 282 cases in the control group and 481 cases in the experimental group. In the experimental group, 204 cases were diagnosed with a heat cough, 225 cases were diagnosed with a cold cough, and 52 cases were not recorded as a heat cough or a cold cough, so these 52 cases were not included in the analysis.

[0078] In order to evaluate the efficacy of the medicated diet composition of the present disclosure in treating a heat cough caused by SARS-CoV-2 infection, the patients with the heat cough were assigned to a medicated diet composition group. Comparative analysis was performed between the control group and the medicated diet composition group.

[0079] 1. Baseline analysis

[0080] Baseline data of the patients are shown in Table 2 below:

[0081] Table 2. Baseline comparison between control Group and medicated diet composition group Variable Total (n = 486) Control group (n = 282) Medicated diet composition group (n = 204) P Statistic s Gender, n (%) 0.036 4.379 Male directors 209 (43.0) 110 (39) 99 (48.5) Female directors 277 (57.0) 172 (61) 105 (51.5) Age, Mean ± SD 38.0 (29.0, 52.0) 37.0 (28.0, 56.0) 39.0 (29.5, 50.0) 0.98 0.001 Time from onset of cough to enrollment, Median (IQR) 6.0 (4.0, 8.0) 5.0 (4.0, 7.0) 6.0 (4.0, 9.2) 0.018 5.633 Whether there is any underlying diseases 55 (11.3) 26 (9.2) 29 (14.2) 0.086 2.944 Hypertension, n (%) 23 (4.7) 8 (2.8) 15 (7.4) 0.021 5.355 Diabetes, n (%) 6 (1.2) 5 (1.8) 1 (0.5) 0.408 Fisher Coronary heart disease, n (%) 6 (1.2) 4 (1.4) 2(1) 1 Fisher Tumor, n (%) 3 (0.6) 1 (0.4) 2(1) 0.575 Fisher Chronic liver disease, n (%) 6 (1.2) 3 (1.1) 3 (1.5) 0.699 Fisher Cerebrovascular disease, n (%) 4 (0.8) 1 (0.4) 3 (1.5) 0.314 Fisher Others, n (%) 14 (2.9) 9 (3.2) 5 (2.5) 0.63 0.232 Smoking or not, n (%) 52 (10.8) 22 (7.8) 30 (14.9) 0.013 6.131 Number of vaccinations, n (%) 0.943 Fisher 0 2 (0.4) 1 (0-4) 1 (0.5) 1 1 (0.2) 1 (0.4) 0(0) 2 63 (13.2) 35 (12.5) 28 (14.1) 3 362 (75.7) 212 (75.7) 150 (75.8) 4 50 (10.5) 31 (11.1) 19 (9.6) Follow-up duration 7.0 (6.0, 7.0) 7.0 (6.0, 7.0) 6.0 (5.0, 7.0) < 0.001 107.43 Taking antitussive medication before enrollment, n (%) 107 (22.2) 69 (24.6) 38 (18.8) 0.134 2.248

[0082] Note: Follow-up duration -Last follow-up date - Baseline table filling date.

[0083] As can be seen from Table 2, a median follow-up duration was 7 days. The patients in the medicated diet composition eroup had a longer duration of coughing, and a higher proportion of smokers. The differences between the two groups were statistically significant (P <0.05).

[0084] 2. Comparison between the two groups before and after propensity score matching

[0085] Propensity score matching was conducted based on the following variables: age, gender, whether there is any underlying diseases, time from onset of cough to enrollment, number of vaccinations, smoking or not, whether antitussive medication was taken before enrollment, and cough symptom score before enrollment. After matching, each group included 178 patients, and the two groups were comparable on all variables except for the number of vaccinations. Comparison results of the two groups after the propensity score matching is shown in Table 3.

[0086] Table 3 Comparison between Two Groups after Propensity Score Matching Variable Control group (n = 178) Medicated diet composition group (n = 178) SMD Female (%) 101 (56.7) 97 (54.5) 0.045 Age (years old) 39.81 (17.74) 39.81 (15.96) < 0.001 Whether there are any underlying diseases (%) 22 (12.4) 24 (13.5) 0.034 Smoking or not 20 (11.2) 21 (11.8) 0.018 Number of vaccinations (%) 0.123 0 1 (0.6) 0 (0.0) 1 0 (0.0) 0 (0.0) 2 26 (14.6) 24 (13.5) 3 135 (75.8) 135 (75.8) 4 16 (9.0) 19 (10.7) Time from onset of cough to enrollment, days 6.46 (3.53) 6.33 (3.83) 0.034 Taking antitussive medication before enrollment, n (%) 34 (19.1) 37 (20.8) 0.042 Cough symptom score before enrollment (mean (sd)) 9.56 (2.97) 9.60 (3.21) 0.013

[0087] Note: SMD stands for standardized mean difference. SMD <0.1 indicates that the two groups are well balanced and comparable.

[0088] 3. Comparison of outcomes after matching

[0089] A regression analysis after the propensity score matching between the two groups is shown in Table 4.

[0090] Table 4 Regression Analysis after Propensity Score Matching between Two Groups Medicated diet composition group (n = 178) Control group (n = 178) Medicated diet composition group VS Control Group HR (95% CI) P Cough disappeared after a median follow-up of 7 days 127 (71.3) 109 (61.2) 1.32 (1.02,1.71) 0.035 Multivariate COX regression* - - 1.33 (1.02-1.72) 0.033

[0091] Note: (1) HR refers to a hazard ratio. HR >1 indicates that, compared with the control group, the patients in the medicated diet composition group is more likely to experience the disappearance of cough symptoms.

[0092] (2) Definition of disappearance of cough symptoms: For patients with a total score >5 according to the cough evaluation test defined in Table 1, and the date from the first medication to the first occurrence of a score of 5 according to the cough evaluation test defined in Table 1 after medication.

[0093] (3) * Since the number of vaccinations was not completely matched between the two groups, the data after matching were used to adjust the confounding factor of the number of vaccinations.

[0094] As can be seen from Table 4, after a median follow-up of 7 days among the patient in the two groups, the disappearance of cough symptoms in the medicated diet composition group was 1.32 times (1.02,1.71) that of the control group.

[0095] 4. Survival curves of the two groups after matching

[0096] In the database after matching, the propensity score matching (PSM) was performed with presence or absence of cough as a dependent variable and grouping information as an independent variable. Kaplan^Meier survival curves were plotted using R (v3.3.2), and a log-rank test method was used to compare differences between the two groups.

[0097] The survival curves of the two groups after matching are shown in FIG. 1. It can be seen from FIG.l that the cough symptoms resolved more quickly among the patients in the medicated diet composition group.

[0098] 5. Comparison of secondary indicators between two groups after propensity score matching

[0099] Comparison results of secondary indicators of the two groups after propensity score matching are shown in Table 5.

[0100] Table 5 Comparison Results of Secondary Indicators between Two Groups after Propensity Score Matching Variable Total (n = 356) Control group (n = 178) Medicated diet zomposition group (n = 178) P Statistics Baseline CET score, Median (IQR) 9.0 (7.0, 11.0) 9.0 (7.0, 11.0) 9.0 (7.0, 12.0) 0.627 0.236 Disappearance of cough symptoms on Day 3, n (%) 135 (42.2) 77 (48.7)a 58 (35.8)b 0.019 5.484 Number of patients followed up on Day 3 320 (89.8) 158 (88.7) 162 (91.0) - - Change in CET score from baseline on Day 3, Median (IQR) 2.0 (1.0, 5.0) 3.0 (2.0, 5.0) 2.0 (0.0, 5.0) 0.058 3.599 Disappearance of cough symptoms on Day 5, n (%) 167 (55.9) 80 (50)° 87 (62.6)d 0.029 4.781 Number of patients followed up on Day 5 299 (83.9) 160 (89.8) 139 (78.1) - - Change in GET score from baseline on Day 5, Median (IQR) 3.0 (2.0, 7.0) 3.0 (2.0, 5.0) 4.0 (1.2,8.0) 0.115 2.481 Disappearance of cough symptoms on Day 7, n (%) 122 (65.9) 39 (40.6)° 83 (93.3)f < 0.001 56.971 Number of patients followed up on Day 7 185 (52.0) 96 (53.9) 89 (50.0) - - Change in GET score from baseline on Day 7, Median (IQR) 3.0 (2.0, 5.0) 3.0 (1.8, 5.0) 2.0 (2.0, 5.0) 0.539 0.378

[0101] Note: (1) GET refers to score defined in the Cough Evaluation Test, which is obtained by scoring according to Table 1.

[0102] (2) There were cases of lost to follow-up on Days 3 and 5, so the numbers of patients followed up on Days 3 and 5 was less than 178. A disappearance rate of cough symptoms rates on Day 3 was a=77 / 158=48.7%; 1)=58 / 162=35.8" and a disappearance rate of cough symptoms rates on Day 5 was c=80 / 160=50%; d=87 / 139=62.6%.

[0103] (3) The treatment period was 5 days, during which the patients completed the GET table every day. The patients whose cough symptoms disappeared in the first 5 days were not followed up on Days 6 and 7; therefore, the number of patients followed up on Day 7 was less than 178, and a disappearance rate of cough symptoms rates on Day 7 was 6=39 / 96=40.6%; 1=83 / 89=93.3%.

[0104] It can be seen from Table 5, on Day 3 of administration, die control group exhibited a higher disappearance rate of cough symptoms, with a statistically significant difference (the medicated diet composition group: 35.8% vs. the control group: 48.7%, P = 0.019). On Day 5 of administration, the medicated diet composition group exhibited a higher disappearance rate of cough symptoms than that in the control group, with a statistically significant difference (the medicated diet composition group: 62.6% vs. the control group: 50%, P = 0.029). On Day 7 of administration, the medicated diet composition group exhibited a higher disappearance rate of cough symptoms than that in the control group, with a statistically significant difference (the medicated diet composition group: 93.3% vs. the control group: 40.6%, P <0.001).

[0105] 6. Conclusions

[0106] After taking the medicated diet composition of the present disclosure, the disappearance rate of cough symptoms in patients with the heat cough caused by SARS-CoV-2 infection was 1.32 (1.02, 1.71) times that of the control group (median follow-up: 7 days). After taking the medicated diet composition of the present disclosure for 5 and 7 days, the disappearance rates of cough symptoms in patients with the heat cough caused by SARS-CoV-2 infection were significantly higher than those in the control group, and the difference was statistically significant, indicating that the medicated diet composition of the present disclosure can significantly improve heat cough symptoms caused by SARS-CoV-2 infection.

[0107] The foregoing merely describes some embodiments of the present disclosure. Those of ordinarily skilled in the art may make several creative transformations and improvements on the premise without deviating from concepts of the present disclosure, these transformations and improvements should be considered to fall within the protection scope of the present disclosure.

Claims

1. A medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection, comprising the following raw materials in parts by mass: 50-100 parts of kumquat, 30-50 parts of Eleocharis dulcis, 5-10 parts of Glehniae radix, and 5-10 parts of Platycodonis radix.

2. The medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection according to claim 1, comprising the following raw materials in parts by mass: 100 parts of kumquat, 50 parts of Eleocharis dulcis, 10 parts of Glehniae radix, and 10 parts of Platycodonis radix.

3. The medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection according to claim 1, comprising the following raw materials in parts by mass: 50 parts of kumquat, 30 parts of Eleocharis dulcis, 5 parts of Glehniae radix, and 5 parts of Platycodonis radix.

4. The medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection according to any one of claims 1-3, further comprising food-grade seasonings or pharmaceutically acceptable excipients.

5. A preparation method for the medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection according to any one of claims 1-4, comprising the following steps:chopping Eileocharis dulcis into pieces, and keeping kumquat whole, mixing the chopped Eleocharis dulcis with the kumquat, Eleocharis dulcis, and Platycodonis radix to obtain a mixture, adding water in an amount of 2-5 times a weight of the raw materials to the mixture, and decocting for 30-60 min to obtain the medicated diet composition.

6. Use of the medicated diet composition for improving a heat cough caused by SARS-CoV-2 infection according to any one of claims 1 -4 in preparing medicine for treating a heat cough caused by SARS-CoV-2 infection accompanied by sore throat or coughing up yellow sputum.PCT / CN2024 / 082514A. CLASSIFICATION OF SUBJECT MATTER A61K 36 / 89(2006.01)i; A61K 36 / 75(2006.01)i; A61K 36 / 34(2006.01)i; A61K 36 / 23(2006.01)i; A61P ll / 14(2006.01)i; A61P 3l / 14(2006.01)i; A23L 33 / 105(2016.01)i According to International Patent Classification (IPC) or to both national classification and IPC B. FIELDS SEARCHED Minimum documentation searched (classification system followed by classification symbols) IPC: A61K, A61P, A23L Documentation searched other than minimum documentation to the extent that such documents are included in the fields searched Electronic data base consulted during the international search (name of data base and, where practicable, search terms used) CNABS, DWPI, VEN, CNTXT, CNMED, CNKI, CJFD, SIPOABS, USTXT, WOTXT, EPTXT, JPTXT, Web of science, 1;1 Chinese Medicine Patent Database (webpage), Won (Drug Standard Database (E Drug Library and National New Drug Registry Data)), ®DUXIU: izW, , )¾¾ tglift, M®, ¢#, iK, W®, Fructus Fortunellae Margaritae, kumquat, Corm Eleocharitis, water chestnut, Radix Glehniae, Radix Platycodi, Radix Platycodonis, cough, hot cough, angina, phlegm, COVID-19, SARS-COV-2 C. DOCUMENTS CONSIDERED TO BE RELEVANT Category* Citation of document, with indication, where appropriate, of the relevant passages Relevant to claim No. PX PX CN 116270865 A (GUANGDONG HOSPITAL OF TRADITIONAL CHINESE MEDICINE (GUANGDONG PROVINCE TRADITIONAL CHINESE MEDICAL HOSPITAL, GUANGDONG TRADITIONAL CHINESE MEDICINE ACADEMY OF SCIENCE)) 23 June 2023 (2023-06-23) claims 1-7 HUA, Qiaoli et al. "Effectiveness of kumquat decoction for the improvement of cough caused by SARS-CoV-2 Omicron variants, a multicentre, prospective observational study" Phytomedicine, No. 120, 11 August 2023 (2023-08-11), pages 1-8 page 2, left-hand column, paragraphs 3-4, page 3, left-hand column, paragraphs 3-4, and page 6, right-hand column, last paragraph to page 7, left-hand column, paragraph 1 1-6 1-6 A CN 110477230 A (HEZHOU UNIVERSITY) 22 November 2019 (2019-11-22) description, paragraphs 4 and 8 1-6 | | Further documents are listed in the continuation of Box C. | J | See patent family annex. * Special categories of cited documents: “T” later document published after the international filing date or priority “A” document defining the general state of the art which is not considered date and not in conflict with the application but cited to understand the to be of particular relevance principle or theory underlying the invention “D” document cited by the applicant in die international application “X” document of particular relevance; the claimed invention cannot be “E" earlier application orpatent but published on or after the international considered novel or cannot be considered to involve an inventive step filing date when the document is taken alone •SL” document which may throw doubts on priority claim(s) or which is “Y” document of particular relevance; the claimed invention cannot be cited to establish the publication date of another citation or other considered to involve an inventive step when the document is special reason (as specified) combined with one or more other such documents, such combination “O” document referring to an oral disclosure, use, exhibition or other being obvious to a person skilled in the art means document member of the same patent family “P” document published prior to the international filing date but later than the priority date claimed Date of the actual completion of the international search 28 May 2024 Date of mailing of the international search report 18 June 2024 Name and mailing address of the ISA / CN China National Intellectual Property Administration (ISA / CN) China No. 6, Xitucheng Road, Jimenqiao, Haidian District, Beijing 100088 Authorized officer Telephone No.PCT / CN2024 / 082514C. DOCUMENTS CONSIDERED TO BE RELEVANTCategory*Citation of document, with indication, where appropriate, of the relevant passagesRelevant to claim No.(LI, Li et al.), (Review on NutritionalValue and Comprehensive Utilization of Kumquat and Present Situation)"(The Food Industry), Vol. 36, No. 9, 20 September 2015 (2015-09-20), pages 220-224page 221, section 1.1(WANG, Jingqi et al.).(Non-official translation: Exploration of Medication Pattern of Chinese Medicine Dietary Treatment of Cough based on Theory of "Preventative Treatment")"(Journal of Inner Mongolia Medical University),Vol. 43, No. 5, 31 October 2021 (2021-10-31), pages 471-475page 472, table 11-61-6PCT / CN2024 / 082514Patent document cited in search report Publication date (day / month / year) Patent family member)s) Publication date (day / month / year) CN 116270865 A 23 June 2023 CN 116270865 B 02 April 2024 CN 110477230 A 22 November 2019 None

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