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1.
ChiCTR; 2023-09-25; TrialID: ChiCTR2300076084
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2300076084

ABSTRACT

Condition:

COVID-19 infected disease

Intervention:

Control Group:Shufeng Jiedu Placebo for 7 days, 2 bags/time, 3 times/day;Test Group:Shufeng Jiedu Granule for 7 days, 2 bags/time, 3 times/day;

Primary outcome:

The time from initiation of treatment to patients’ COVID-19 related-symptoms sustained clinical recovery.;

Criteria:

Inclusion criteria: (1)Age (18 = and =65) years old, gender is not limited;
(2)Meet the diagnosis of The Pneumonia Diagnosis and Treatment Guideline for Novel Corona-virus Infection (Trial Version 10);
(3)Clinical classification is mild;
(4)Traditional Chinese medicine syndrome differentiation is Yidu Shubiao Syndrome;
(5)Within 72 hours from the onset of COVID-19-related symptoms to random enrollment (details are provided in Supplemental Appendix 1);
(6)At least one COVID-19-related symptom (cough, nasal congestion, sore throat, fever) score = 2 points : Cough Fatigue; Nausea; Dysgeusia Stuffy or Runny Nose; Headache; Vomit; Dysosmia Sore or Dry Throat; Fever; Diarrhea Shortness of Breath or Difficulty Breathing; Muscle or General Body Pain Chills or Shaking;
(7) Volunteer to participate in this clinical trial, give informed consent and sign the informed consent form.

Exclusion criteria: (1) The clinical classification of COVID-19 is moderate, severe, and critical;
(2) Combining diseases with the same clinical manifestations as COVID-19-related symptoms, such as influenza, infectious diseases with the above symptoms as prodromal symptoms, pneumonia, suppurative tonsillitis, acute tracheo-bronchitis, tuberculosis, and primary ciliary movement Dysfunction syndrome, other acute nasal diseases (such as allergic rhinitis, acute and chronic rhinitis, acute and chronic sinusitis, etc.), nasal mucosal dysfunction after nasal surgery or nasopharynx radiotherapy;
(3) Patients with serious cardiovascular and cerebrovascular diseases (including hypertension with uncontrolled and stable blood pressure), chronic lung diseases, diabetes, chronic liver, kidney diseases, tumors and other basic diseases, as well as maintenance dialysis patients;
(4) Immunodeficiency (such as AIDS patients, long-term use of corticosteroids or other immunosuppressive drugs lead to a state of hypoimmune function);
(5) Obesity (body mass index = 30kg/m2);
(6) Severe smoking (smoking severity index = 4 points);
(7) Liver function ALT and AST exceed 2 times the upper limit of the normal reference value or Scr exceeds the upper limit of the normal reference value;
(8) 4 hours before enrollment, used anti-new coronary pneumonia virus infection, cold medicine, antiviral medicine, antibiotics, antipyretic analgesics and other traditional Chinese medicines and chemical medicines that affect the evaluation of curative effect;
(9) Combined with serious primary diseases such as hematopoietic system and mental illness;
(10) Pregnancy or women who plan to become pregnant or breastfeeding during the study period;
(11) History of allergy to the test drug ingredients;
(12) History of long-term alcoholism and drug abuse;
(13) Participated in other interventional drug clinical trials within the past month;
(14) The investigator thinks patients who is not suitable to participate in this clinical trial.

2.
Biosci Trends ; 17(1): 14-20, 2023 Mar 11.
Article in English | MEDLINE | ID: covidwho-2311804

ABSTRACT

Coronavirus Disease 2019 (COVID-19) has been an unprecedented disaster for people around the world. A point particularly worth noting is that herbal medicines have made great contributions to the prevention and treatment of COVID-19 in China. Angiotensin converting enzyme 2 (ACE2) has been identified as the critical functional receptor for SARS-CoV-2. It can bind to the receptor-binding domain (RBD) of the spike protein (S protein), which is responsible for the entry of the coronavirus into host cells. Therefore, ACE2 can be regarded as an important intervention target for COVID-19. Recently, many herbal medicines have exhibited a high affinity for ACE2 in treating COVID-19. The current work summarized these herbal medicines including formulas (such as Lianhua Qingwen capsules, Xuebijing injection, Qingfei Paidu Decoction, Huashi Baidu formula, Shufeng Jiedu capsules, and Maxing Shigan decoction), single herbs including Ephedra sinica Stapf (Mahuang), Scutellariae radix (Huangqin), Lonicera japonica (Jinyinhua), and Houttuynia cordata (Yuxingcao), and active ingredients (such as ursodeoxycholic acid, glycyrrhizic acid, glycyrrhizin, salvianolic acid, quercetin, and andrographidine C), which have exhibited a high affinity for ACE2 in treating COVID-19. We hope this work may provide meaningful and useful information on further research to investigate the mechanisms of herbal medicines against SARS-CoV-2 and follow-up drug discovery.


Subject(s)
COVID-19 , Humans , SARS-CoV-2 , Angiotensin-Converting Enzyme 2 , Capsules , Protein Binding
3.
Chin Med ; 18(1): 45, 2023 Apr 25.
Article in English | MEDLINE | ID: covidwho-2296136

ABSTRACT

Shufeng Jiedu Capsule (SFJDC), composed of eight herbs, is a big brand traditional Chinese medicine (TCM) for the treatment of different respiratory tract infectious diseases with good clinical efficacy and few side effects. It is clinically applied to acute upper respiratory tract infection(URI), influenza, acute exacerbation of chronic obstructive pulmonary disease (AECOPD), community-acquired pneumonia(CAP) and other diseases, due to its antibacterial, antiviral, anti-inflammatory, immunoregulatory and antipyretic activities. In particular, it has shown good clinical effects for COVID-19, and was included in the fourth to tenth editions of the 'Diagnosis and Treatment Protocol for COVID-19 (Trial)' by the National Health Commission. In recent years, studies on the secondary development which focus on the basic and clinical application of SFJDC have been widely reported. In this paper, chemical components, pharmacodynamic material basis, mechanisms, compatibility rule and clinical application were systematically summarized, in order to provide theoretical and experimental basis for further research and clinical application of SFJDC.

4.
Curr Med Chem ; 2023 Mar 31.
Article in English | MEDLINE | ID: covidwho-2260229

ABSTRACT

The coronavirus disease 2019 (COVID-19) pandemic still has tremendous impacts on the global socio-economy and quality of living. The traditional Chinese Medicines (TCM) approach showed encouraging results during previous outbreaks of Severe Acute Respiratory Syndrome-related coronavirus (SARS-CoV) and the Middle East Respiratory Syndrome Coronavirus (MERS-CoV). With limited treatment availability, TCM herbs and formulations could be viable to reduce COVID-19 symptoms and potential sources for discovering novel therapeutic targets. We reviewed 12 TCM herbs and formulations recommended for COVID-19 management by the National Health Commission and National Administration of Traditional Chinese Medicine, the People's Republic of China. This article explored the Chinese national authorities' guidelines from 2003 to 2020, the scientific data in public databases for the recommended TCM remedies, and their potential mechanistic actions in COVID-19 management. Several TCM herbs and formulations could potentially benefit COVID-19 management. The recommended TCM oral preparations list are Huoxiang zhengqi, Jinhua Qinggan, Lianhua Qingwen, and Shufeng jiedu; the recommended injection preparations comprise Xiyanping Xuebijing, Re-Du-Ning, Tanreqing, Xingnaojing, Shenfu, Shengmai, and Shenmai. TCM remedies are viable options for symptom alleviation and management of COVID-19. The current SARS-CoV-2 pandemic presents an opportunity to find novel therapeutic targets from TCM-active ingredients. Despite the recommendations in Chinese National guidelines, these remedies warrant further assessments in well-designed clinical trials for their efficacies in COVID-19.

5.
ChiCTR; 2023-04-26; TrialID: ChiCTR2300070933
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2300070933

ABSTRACT

Condition:

COVID-19

Intervention:

Experimental group:Basic treatment + Cangma Huadu granules;Control group:Basic treatment + placebos;

Primary outcome:

Clinical symptom remission time;

Criteria:

Inclusion criteria: (1) Patients who have been diagnosed with mild COVID-19 according to the Diagnosis and Treatment Protocol for Novel Coronavirus Infection (Trial Version 9);
(2) 60 years old =aged =18 years old;
(3) Treatment time from onset to inclusion =72h;
(4) The patient is informed and agrees to sign the informed consent.

Exclusion criteria: (1) Mentally ill persons, or other persons unable to cooperate or unwilling to cooperate;
(2) Participants in other trials within the last 3 months;
(3) The patient is known to have the following risk factors:
a) Pregnant women or women in the puerperal period;
b) Chronic respiratory diseases, including COPD and asthma attacks;
c) neurological diseases and neurodevelopmental disorders, including brain, spinal cord, peripheral nerve and muscle diseases (e.g., cerebral palsy, epilepsy [convulsive attacks], stroke, intellectual disability, moderate to severe developmental delay, muscular dystrophy or spinal cord injury);
d) Heart disease (e.g., congenital heart disease, congestive heart failure or coronary artery disease), excluding high blood pressure without any other heart-related symptoms;
e) Diseases of the blood system;
f) endocrine system diseases (excluding HBA1c < 8%);
g) Kidney disease: creatinine clearance =60 mL/min;
h) Liver diseases (including hepatitis, cirrhosis, moderate to severe fatty liver, but excluding asymptomatic abnormal liver function with AST or ALT elevated less than 50% of the upper limit of normal);
i) Metabolic disorders (protein metabolism, glucose metabolism, lipid metabolism, water and electrolyte metabolism, hyperuricemia);
j) compromised immune systems (including patients on immunosuppressive therapy, or patients with cancer or human immunodeficiency virus [HIV] infection);
k) Obese patients (body mass index [BMI]=30).
(4) Weight of indicator cases < 40 kg;
(5) a history of alcohol or drug abuse;
(6) have received or are receiving anti-COVID-19 drugs such as Ritonavir and azfudine tablets;
(7) Antipyretic and analgesic drugs were used within 6 hours;
(8) Chinese patent medicines with antiviral properties (such as Jinhua Qinggan, Lianhua Qingwen, Qingkailing Granules (oral liquid), Shufeng Jiedu capsules, Yinqiao Jiedu, Sangju colds, Yinhuang preparations) should be used within 12h

6.
ChiCTR; 2023-04-23; TrialID: ChiCTR2300070776
Clinical Trial Register | ICTRP | ID: ictrp-ChiCTR2300070776

ABSTRACT

Condition:

SARS-CoV-2 infection

Intervention:

no-treatment control group:Shufeng Jiedu Capsules (COVID-19 recommended general treatment plan for the ninth version);Treatment group 1:Lentinan 25ug/d×5 days+Shufeng Jiedu Capsules (COVID-19 recommended general treatment plan for the ninth version);Treatment group 2:Lentinan 50ug/d×5 days+Shufeng Jiedu Capsules (COVID-19 recommended general treatment plan for the ninth version);Treatment group 3:Lentinan 100ug/d×5 days+Shufeng Jiedu Capsules (COVID-19 recommended general treatment plan for the ninth version);

Primary outcome:

Virus negative rate;

Criteria:

Inclusion criteria: 1. Voluntary signing of informed consent form
2. At least 18 years old but less than 60 years old; Gender unlimited
3. Within 5 days prior to screening, with or without COVID-19 related symptoms, SARS-CoV-2 infection was confirmed through PCR detection within 24 hours;
4. Agree not to participate in other interventional clinical trials for the treatment of SARS-CoV-2 during the study period
5. Agree to the detailed sampling requirements in the evaluation schedule and comply with the research requirements

Exclusion criteria: 1. COVID-19 positive patients;
2. Patients with bleeding tendencies
3. Allergy to shiitake mushroom polysaccharides or their pharmaceutical components;
4. Have experienced severe allergic reactions, including systemic urticaria, vascular edema, and hypersensitivity reactions
5. Received COVID-19 rehabilitation plasma and SARS-CoV-2 antibody treatment;
6. Have received other investigational drugs for the treatment of COVID-19;
7. Pregnant or lactating women;
8. Those who merge with other serious systemic diseases;
9. According to the judgment of the researcher, it is deemed unsuitable to participate in this study;

7.
Drug Discov Ther ; 16(6): 258-272, 2022 Dec 26.
Article in English | MEDLINE | ID: covidwho-2217405

ABSTRACT

As an indispensable part of Traditional Chinese medicine (TCM), Chinese patent medicines have played an important role in preventing and treating diseases in China. Since they are easy to use, easy to store, and cost-effective, Chinese patent medicines have been generally accepted and widely used in Chinese clinical practice as a vital medical resource. In recent years, as TCM has developed and it has been accepted around the world, many Chinese patent medicine companies have gained international market access and successfully registered several Chinese patent medicines as over-the-counter (OTC) or prescription drugs in regions and countries that primarily use Western medicine such as the EU, Russia, Canada, Singapore, and Vietnam. Moreover, several Chinese patent medicines have been obtained the US Food and Drug Administration (FDA) approval conducting phase II or III clinical trials in the US. The current work has focused on several Chinese patent medicines that have been successfully registered or that have been submitted for registration abroad. Summarized here are recent advances in the efficacy and molecular mechanisms of these Chinese patent medicines to treat respiratory infectious diseases (Lianhua Qingwen capsules, Jinhua Qinggan granules, and Shufeng Jiedu Capsules), cardiovascular and cerebrovascular diseases (Compound Danshen Dripping Pills, Huatuo Zaizao pills, and Tongxinluo Capsules), cancers (a Kanglaite injection and a Shenqi Fuzheng Injection), and gynecological diseases (Guizhi Fuling Capsules). The hope is that this review will contribute to a better understanding of Chinese patent medicines by people around the world.


Subject(s)
Drugs, Chinese Herbal , Nonprescription Drugs , Humans , Capsules , China , Drugs, Chinese Herbal/therapeutic use , Medicine, Chinese Traditional , Nonprescription Drugs/therapeutic use
8.
Medicine (Baltimore) ; 100(40): e27372, 2021 Oct 08.
Article in English | MEDLINE | ID: covidwho-2191071

ABSTRACT

BACKGROUND: Coronavirus disease 2019 (COVID-19) in many countries is still very serious. At present, there is no specific and effective drug for this disease. Traditional Chinese medicine (TCM) has played a great role in fighting against COVID-19. However, their effectiveness and safety are still obscure and deserve further investigation. The aim of the study was to evaluate the efficacy and safety of TCM assisted in conventional treatment in the treatment of mild and common COVID-19. METHODS: PubMed, EMbase, MEDLINE, China National Knowledge Infrastructure Database, WANFANG DATA, and VIP Chinese Science and Technology Periodical Database were searched for randomized controlled trials (RCTs) and non-randomized controlled trials of TCM assisted in conventional treatment. The RCT research quality was evaluated by Cochrane 5.1.0 bias risk scale and the non-randomized controlled trial research quality was evaluated by Newcastle Ottawa scale, and the statistical analysis was conducted by Revman 5.3 and R software. The bias and sensitivity of the statistical results were analyzed by STATA 14.0. Registration number: CRD42020210619. RESULTS: Fifteen studies were included with 7 RCT studies and 8 retrospective cohort studies, involving a total of 1623 patients. Compared with the control group, TCM can improve the main index clinical effective rate (odds ratio [OR] = 2.64, 95% Confidence interval (CI) [1.94,3.59], P < .00001). The results of Begg test (Pr > z = 0.266) and sensitivity analysis showed that the results were relatively stable. Toujie Quwen (OR = 4.9, 95%CI [1.9,14.0]), Shufeng Jiedu (OR = 2.9, 95%CI [1.5,5.7]), and Lianhua Qingwen (OR = 2.4, 95%CI [1.6,3.6]) were with the best. It can also improve the main clinical symptoms (fever, cough, fatigue, and the regression time of the 3 symptoms), severe conversion rate, and computed tomography improvement rate. Its safety was not significantly compared with conventional treatment. However, in terms of safety of a single TCM, Shufeng Jiedu (OR = -0.86, 95%CI [-1.89,0.09]) and Lianhua Qingwen (OR = -0.49, 95%CI[-0.94,-0.05]) were lower than those of conventional treatment. CONCLUSION: TCM as an adjuvant therapy combined with conventional treatment has good curative effect on mild and common type of COVID-19 patients. Its advantages lie in clinical efficacy and improvement of symptom group, and can prevent patients from transforming to severe disease. In terms of clinical efficacy and safety, Shufeng Jiedu and Lianhua Qingwen have obvious advantages, which are worthy of clinical promotion.


Subject(s)
COVID-19/therapy , Drugs, Chinese Herbal/therapeutic use , Combined Modality Therapy , Drugs, Chinese Herbal/administration & dosage , Drugs, Chinese Herbal/adverse effects , Humans , Randomized Controlled Trials as Topic , SARS-CoV-2 , Severity of Illness Index
9.
Journal of Chinese medicinal materials ; 44(1):253-266, 2021.
Article in Chinese | EMBASE | ID: covidwho-2145396

ABSTRACT

Objective: To study the mechanism of Shufeng jiedu granules in treating Corona Virus Disease 2019(COVID-19)based on network pharmacology. Method(s): TCMSP database was used to search and screen the active components of Shufeng jiedu granules, GeneGards database was used to predict and screen disease targets, the common targets of the above two were input into the STRING database to obtain the target protein interaction network, the PPI network and the "traditional Chinese medicines-components-targets-diseases" network were constructed by using Cytoscape 3.7.2 software, and the GO function enrichment analysis and KEGG pathway enrichment analysis were carried out by using Cytoscape 3.7.2 software, R software and the corresponding program package. Result(s): A total of 207 active components and 1 006 traditional Chinese medicine component targets were screened, and 350 COVID-19-related targets were identified, so as to obtain 49 common drug-disease targets.GO functional enrichment analysis resulted in 1 575 items(P<0.05), KEGG enrichment analysis resulted in 120 related signaling pathways(P<0.05), mainly involving IL-17 signaling pathway, TNF signaling pathway, etc. Conclusion(s): Shufeng jiedu granules may achieve the therapeutic effect of COVID-19 through multi-targets, multi-pathways to regulate virus and inflammation-related pathways. Copyright © 2021, Central Station of Chinese Medicinal Materials Information, National Medical Products Administration. All right reserved.

10.
Front Med (Lausanne) ; 9: 1020286, 2022.
Article in English | MEDLINE | ID: covidwho-2099180

ABSTRACT

Introduction: Shufeng Jiedu capsule (SFJD) is a commonly used Chinese patent medicine in China. Some studies have reported that SFJD has therapeutic effects in patients diagnosed with COVID-19. This systematic review aimed to critically evaluate the efficacy and safety of SFJD combined with western medicine (WM) for treating COVID-19. Methods: A literature search by using WHO COVID-19 database, PubMed, Embase, Cochrane Library, the Web of Science, CKNI, Wanfang, VIP, SinoMed, and clinical trial registries was conducted, up to 1 August 2022. Randomized controlled trials (RCTs), non-RCTs, cohort studies and case series of SFJD combined with WM for COVID-19 were included. Literature screening, data extraction, and quality assessment were performed independently by two reviewers in line with the same criteria. We used the Grading of Recommendations, Assessment, Development, and Evaluations (GRADE) to assess the certainty of evidence. Meta-analyses were performed with Revman 5.3 if possible. The descriptive analysis was conducted when the studies could not be meta-analyzed. Results: Totally 10 studies with 1,083 patients were included. Their methodological quality were moderate. The results demonstrated that compared to WM group, SFJD + WM group remarkably increased the nucleic acid negative conversion rate (RR = 1.40, 95%CI: 1.07-1.84), total effective rate (RR = 1.18, 95%CI: 1.07-1.31), cure rate (RR = 4.06, 95%CI: 2.19-7.53), and the chest CT improvement rate (RR = 1.19, 95%CI: 1.08-1.31), shorten nucleic acid negative conversion time (MD = -0.70, 95%CI: -1.14 to -0.26), reduced the clinical symptom disappearance time (fever, diarrhea, cough, fatigue, pharyngalgia, nasal congestion, and rhinorrhea), as well as improved the levels of laboratory outcomes (CRP, IL-6, Lym, and Neu). Additionally, the incidence of adverse reactions did not exhibit any statistically significant difference between SFJD + WM group and WM group. Conclusion: SFJD combined with WM seems more effective than WM alone for the treatment of COVID-19. However, more well-designed RCTs still are warranted. Systematic review registration: [https://www.crd.york.ac.uk/PROSPERO/], identifier [CRD42022306307].

11.
Heliyon ; 8(11): e11120, 2022 Nov.
Article in English | MEDLINE | ID: covidwho-2069056

ABSTRACT

Objective: To perform a bibliometric analysis of published research related to the use of traditional Chinese medicine (TCM) for the treatment of Coronavirus Disease 2019 (COVID-19). Methods: Research documents related to the use of TCM for prevention and treatment of COVID-19 published up to September 19, 2021, were retrieved from the Web of Science database. Bibliometrix R 4.0 software package was used to analyze data, including countries of publication, research institutions, journals, citations, and keywords. Further analysis was conducted to identify co-occurrence of keywords in the documents, including their titles and abstracts. Cooperative network analyses of authors, institutions, and countries of publication were also conducted. The classification types were statistically analyzed and the research progress of key TCMs was reviewed. Results: A total of 417 documents were included in our analysis. Of these, 85.13% originated in China. Of the 417 documents, 148 (35.5%) were published in journals with impact factors in quartile 1 and 164 (39.3%) in journals in quartile 2. The documents were mainly published in journals categorized as Medicine. The results of network analysis showed close cooperation between institutions and countries. Excluding disease- and drug-related keywords, the top four keywords were 'Systematic review', 'Network pharmacology', 'Medicine' and 'Molecular docking'. Keyword co-occurrence analysis showed 4 main keywords association groups. Statistical analysis of the TCM studies showed that Lianhua Qingwen capsule, Qingfei Paidu decoction, Shufeng Jiedu capsules and ReDuNing injection were the most studied Chinese medicines. Lianhua Qingwen capsules, Qingfei Paidu decoction, ReDuNing injection, and Shufeng Jiedu capsules were used in clinical, bioinformatics, and basic research. Toujie Quwen granule, Jinhua Qinggan granule, Shuanghuanglian oral liquid, Tanreqing injection, and Xuanfei Baidu decoction were used in clinical and bioinformatics research, although basic research on their mechanisms of action is lacking. Conclusion: Research intensity and recognition, as well as cooperation, in the field of Chinese medicine for the prevention and treatment of COVID-19 has increased. Research types are generally comprehensive, and investigated several TCM formulations that are specifically recommended by Chinese COVID-19 guidelines. However, comprehensive, in-depth research on their molecular mechanisms of action is still lacking. More basic research is thus needed to identify therapeutic mechanisms to standardize and validate the use of TCM in the prevention and treatment of COVID-19.

12.
Biosci Trends ; 16(3): 238-241, 2022 Jul 20.
Article in English | MEDLINE | ID: covidwho-1964370

ABSTRACT

Patients infected with the Omicron variant of SARS-CoV-2 mainly develop mild COVID-19, manifesting as upper respiratory symptoms, fatigue, and fever. Shufeng Jiedu capsule (SFJDC), a traditional Chinese medicine indicated for treatment of upper respiratory infections in China, was tested for its efficacy and safety in treatment of an Omicron infection at a mobile cabin hospital in response to an outbreak of COVID-19 in Shanghai, China in April 2022. In this open-label, randomized controlled trial, patients in the control group received best supportive care, while those in the test group received additional SFJDC therapy for 7 days. SFJDC markedly alleviated patients' symptoms including a sore throat, coughing, fatigue, and a fever after 7 days of treatment. The virus negative time was significantly shorter in the SFJDC treatment group, but there were no obvious differences in the virus negative rate between the two groups at the end of the 7-day follow-up. These results suggest that patients with the Omicron infection may benefit from SFJDC treatment. Double-blind, randomized controlled trials are warranted to comprehensively evaluate the efficacy and safety of SFJDC in a large cohort study in the future.


Subject(s)
COVID-19 , SARS-CoV-2 , China , Cohort Studies , Drugs, Chinese Herbal , Fatigue , Humans , Medicine, Chinese Traditional , Randomized Controlled Trials as Topic
13.
Chinese Traditional and Herbal Drugs ; 53(11):3557-3563, 2022.
Article in Chinese | EMBASE | ID: covidwho-1884661

ABSTRACT

Shufeng Jiedu Capsules are composed of eight traditional Chinese medicines, including Huzhang (Polygoni Cuspidati Rhizoma et Radix), Lianqiao (Forsythiae Fructus), Baijiangcao (Herba Patriniae), Chaihu (Bupleuri Radix), etc. Shufeng Jiedu Capsules has exactly effects such as dispelling wind and clearing heat, removing toxin and relieving sore-throat, which had been used in treatment of respiratory infectious diseases with symptom like fever, intolerating wind in clinic for a long time. Shufeng Jiedu Capsules are the recommended drugs for the "Influenza Diagnosis and Treatment Plan" (2020 version)issued by National Health Commission and "Diagnosis and Treatment of Pneumonia in COVID-19"(version 4, 5, 6, 7, 8 and 9). Pharmacological mechanism and clinical application of Shufeng Jiedu Capsules weresummarized in this paper, in order to summarize characteristic and the post-marketing research path of Shufeng Jiedu Capsules, and provide ideas for more post-marketing traditional Chinese medicine products.

14.
ISRCTN; 03/05/2022; TrialID: ISRCTN14236594
Clinical Trial Register | ICTRP | ID: ictrp-ISRCTN14236594

ABSTRACT

Condition:

COVID-19 (SARS-CoV-2 infection)
Infections and Infestations

Intervention:


Experimental group: Shufeng Jiedu Capsule, taken orally for 5 days.
Control group: Shufeng Jiedu placebo, taken orally for 5 days.
After 5 days of treatment, all participants are no longer taking any Traditional Chinese medicine. Participants were followed up for 14 days after discharge.
Participants are randomly allocated to groups using the coded boxes of pills.


Primary outcome:

Time to alleviation of symptoms (TTAS). Clinical symptoms are based on flu-like associated symptoms, including cough, stuffy nose, sore throat, fever or chills, muscle/joint pain, headache, and fatigue measured using self-report on a 0-3 scale (0 as no symptoms, 1 as mild symptoms, 2 as moderate symptoms and 3 as severe symptoms) at baseline, every day during the intervention (from 1st-6th day), and every day during follow-up (since discharged from hospital until 14th day).

Criteria:

Inclusion criteria:
1. Meet the mild and common diagnostic criteria for COVID-19;
2. The time interval between symptom onset and random enrollment was less than 3 days;
3. Adults (=18 and =75 years);
4. Agree to participate in this study and accept random grouping;
5. Those who have signed informed consent and are not currently participating in other clinical trials of traditional Chinese medicine for COVID-19


Exclusion criteria:
1 Female patients in pregnancy and lactation;
2 Patients with a history of allergy to the test drug ingredients;
3. As judged by the investigator, or patients with acute episodes, cognitive insufficiency, or severe diarrhea (resulting in electrolyte disturbances and dehydration);
4. Continuous use of traditional Chinese medicine (tripartite and three-drug treatment) for COVID-19 within 3 days before enrollment;
5. Patients who are also participating in other clinical trials.

15.
J Pharm Anal ; 12(2): 270-277, 2022 Apr.
Article in English | MEDLINE | ID: covidwho-1757596

ABSTRACT

A fast, reliable, and cost-effective liquid chromatography-tandem mass spectrometry method was established to determine the effects of the traditional Chinese medicine employed to treat coronavirus disease 2019, namely, Lianhua Qingwen granules, Huoxiang Zhengqi capsules, Jinhua Qinggan granules, Shufeng Jiedu capsules, and Angong Niuhuang pills, on the pharmacokinetics of lopinavir/ritonavir in rats. Blood samples were prepared using the protein precipitation method and atazanavir was selected as the internal standard (IS). Separation was performed on an Agilent ZORBAX eclipse plus C18 (2.1 mm × 50 mm, 1.8 µm) column using acetonitrile and water containing 0.1% formic acid as the mobile phase for gradient elution. The flow rate was 0.4 mL/min and the injection volume was 2 µL. Agilent Jet Stream electrospray ionization was used for mass spectrometry detection under positive ion multiple reaction monitoring mode at a transition of m/z 629.3→447.3 for lopinavir, m/z 721.3→296.1 for ritonavir, and m/z 705.4→168.1 for the IS. The method showed good linearity in the concentration range of 25-2500 ng/mL (r=0.9981) for lopinavir and 5-500 ng/mL (r=0.9984) for ritonavir. The intra-day and inter-day precision and accuracy were both within ±15%. Items, such as dilution reliability and residual effect, were also within the acceptable limits. The method was used to determine the effects of five types of traditional Chinese medicines on the pharmacokinetics of lopinavir/ritonavir in rats. The pharmacokinetic results showed that the half-life of ritonavir in the groups administered Lianhua Qingwen granules and Huoxiang Zhengqi capsules combined with lopinavir/ritonavir was prolonged by approximately 1.5- to 2-fold relative to that in the control group. Similarly, the pharmacokinetic parameters of lopinavir were altered. Overall, the results of this study offer important theoretical parameters for the effective clinical use of five types of traditional Chinese medicines combined with lopinavir/ritonavir to reduce the occurrence of clinical adverse reactions.

16.
Journal of Pharmaceutical Research ; 40(9):590-597, 2021.
Article in Chinese | CAB Abstracts | ID: covidwho-1726936

ABSTRACT

Objective: To screen potential active ingredients of Shufeng Jiedu Capsule(SJC)for novel coronavirus pneumonia(COVID-19).

17.
Chin Med ; 16(1): 130, 2021 Dec 03.
Article in English | MEDLINE | ID: covidwho-1551216

ABSTRACT

The Coronavirus disease 2019 (COVID-19) pandemic is still spread and has made a severe public health threat around the world. To improve disease progression, emerging Chinese herbal compounds were used in clinical practice and some agents have proven beneficial in treating COVID-19. Here, the relevant literature from basic researches to clinical application were identified and comprehensively assessed. A variety of Chinese herbal compounds have been reported to be effective in improving symptoms and outcomes in patients with COVID-19, particularly together with routine treatment strategy. The pharmacological activities were mainly attributed to the relief of clinical symptoms, inhibition of cytokine storm, and improvement of organ function. Besides, the development of novel antiviral drugs from medicinal herbs were further discussed. The updated laboratory and clinical studies provided the evidence of Chinese herbal compounds such as Lianhua Qingwen prescription, Shufeng Jiedu prescription, and Qingfei Paidu Tang for the relief of COVID-19. However, both of the randomized controlled trials and real world researches need to be done for supporting the evidence including the efficacy and safety in fighting COVID-19.

18.
Phytochem Rev ; 21(1): 219-237, 2022.
Article in English | MEDLINE | ID: covidwho-1378978

ABSTRACT

Whilst Western research for the COVID-19 crisis focuses on vaccination, in East Asia traditional herbal prescriptions are studied for SARS-CoV2 therapy. In Japan, Maoto (Ephedrae herba 4 g, Armeniacae semen 4 g, Cinnamomi cortex 3 g, and Glycyrrhizae radix 2 g, JPXVII) is used based on clinical evidence for its effect on early phase influenza (also caused by RNA viruses) comparable to that of oseltamivir. The Health Ministry of Thailand has approved Andrographis paniculata (Jap. Senshinren) extracts for treatment of COVID-19. Its combination (4 g) with Maoto, Maoto-ka-senshinren, seems most promising for the treatment of viral pandemics. In China, the official guideline for COVID-19 treatment contains TCM medications with antiviral, as well as immunmodulatory and anti-inflammatory effects such as: Qing-Fei-Pai-Du-Tang (Jap. Seihai-haidokuto) contains 21 drugs; Shufeng Jiedu Jiaonang (Bupleuri radix 8 g, Forsythiae fructus 8 g, Glycyrrhizae radix 4 g, Isatidis radix 8 g, Patriniae herba 8 g, Phragmitis rhizoma 6 g, Polygoni cuspidati rhizoma 10 g, Verbenae herba 8 g); Fufang Yuxingcao Heiji (Forsythiae fructus 0.6 g, Houttuyniae herba 6 g, Isatidis radix 1.5 g, Lonicerae flos 0.6 g, Scutellariae radix 1.5 g) first gained prominence during the 2002 SARS epidemic. With no Western medicine available, the following overview discusses efficacy and mechanisms in view of viral entry and replication of different East Asian herbal remedies for COVID-19 treatment.

19.
Zhonghua Wei Zhong Bing Ji Jiu Yi Xue ; 33(6): 714-720, 2021 Jun.
Article in Chinese | MEDLINE | ID: covidwho-1323328

ABSTRACT

OBJECTIVE: To evaluate the clinical efficacy and safety of combination of traditional Chinese and Western medicine in the treatment of coronavirus disease 2019 (COVID-19) by Meta analysis. METHODS: The clinical randomized controlled trials (RCT) and cohort studies on the treatment of COVID-19 with combination of Chinese traditional and Western medicine published on CNKI, Wanfang database, VIP database and PubMed were searched by computer from January 2020 to June 2020. Patients in the simple Western medicine treatment group were treated with routine treatment of Western medicine, and the patients in integrated traditional Chinese and Western medicine treatment group were treated with traditional Chinese medicine on the basis of routine treatment of Western medicine. The main outcome was the total effective rate of treatment. The secondary outcome were the antipyretic rate, chest CT recovery rate, lymphocyte count (LYM), C-reactive protein (CRP) level and safety. The Cochrane manual and the Newcastle Ottawa Scale (NOS) were used to evaluate the quality of the literature; the RevMan5.3 software was used to analyze the articles that meets the quality standards, and a funnel chart was drawn to evaluate the total effective publication bias. RESULTS: Thirteen articles were analyzed, including 1 039 COVID-19 patients, 559 in integrated traditional Chinese and Western medicine treatment group and 480 in simple Western medicine treatment group. The results of Meta- analysis showed that compared with the simple Western medicine treatment group, the combination of routine treatment of Western medicine and traditional Chinese medicine Qingfei Paidu decoction, Lianhua Qingwen granule, Shufeng jiedu capsule, Xuebijing injection or Reyanning mixture could significantly improve the total effective rate, antipyretic rate and chest CT recovery rate [total effective rate: odds ratio (OR) = 2.95, 95% confidence interval (95%CI) was 2.10-4.14, P < 0.000 01; antipyretic rate: OR =3.01, 95%CI was 1.64-5.53, P = 0.000 4; chest CT recovery rate: OR = 2.53, 95%CI was 1.83-3.51, P = 0.000 1], increase LYM levels [mean difference (MD) = 0.26, 95%CI was 0.02-0.50, P = 0.03], and reduce of CRP content (MD = -17.68, 95%CI was -33.14 to -2.22, P = 0.02). Based on the funnel chart analysis of 12 articles with total efficiency, the result showed that the funnel chart distribution was not completely symmetrical, indicating that there might be publication bias. CONCLUSIONS: On the basis of routine treatment with Western medicine, combined with traditional Chinese medicine can significantly improve the total effective rate of COVID-19 and improve the laboratory results and clinical symptoms of patients. Compared with the routine treatment of Western medicine alone, the combination of traditional Chinese and Western medicine has better clinical efficacy and safety.


Subject(s)
COVID-19 , Drugs, Chinese Herbal , China , Drugs, Chinese Herbal/therapeutic use , Humans , Medicine, Chinese Traditional , SARS-CoV-2 , Treatment Outcome
20.
Pharmacol Res ; 158: 104896, 2020 08.
Article in English | MEDLINE | ID: covidwho-1318933

ABSTRACT

Corona virus disease (COVID-19) has now spread to all parts of the world and almost all countries are battling against it. This study aimed to assess the efficacy and safety of Integrated Traditional Chinese and Western Medicine (Hereinafter referred to as "Integrated Medicine") to COVID-19. We searched six major Chinese and English databases to identify randomized controlled trials (RCTs) and case-control studies (CCSs) of Integrated Medicine on COVID-19. Two reviewers independently screened, identified studies, and extracted data. Cochrane Risk of Bias tool and the Newcastle-Ottawa Scale were used to assess the quality of included RCTs and CCSs, respectively. Stata (version 13.0; StataCorp) was used to perform meta-analyses with the random-effects model. Risk ratio (RR) was used for dichotomous data while the weighted mean difference (WMD) was adopted for continuous variables as effect size, both of which were demonstrated in effect size and 95% confidence intervals (CI). A total of 11 studies were included. Four were RCTs and seven were CCSs. The sample size of including studies ranged from 42 to 200 (total 982). The traditional Chinese medicine included Chinese medicine compound drugs (QingFei TouXie FuZhengFang) and Chinese patent medicine (e.g. Shufeng Jiedu Capsule, Lianhua Qingwen granules). Compared with the control group, the overall response rate [RR = 1.230, 95%CI (1.113, 1.359), P = 0.000], cure rate [RR = 1.604, 95%CI (1.181, 2.177), P = 0.002], severity illness rate [RR = 0.350, 95%CI (0.154, 0.792), P = 0.012], and hospital stay [WMD = -1.991, 95%CI (-3.278, -0.703), P = 0.002] of the intervention group were better. In addition, Integrated Medicine can improve the disappearance rate of fever, cough, expectoration, fatigue, chest tightness and anorexia and reduce patients' fever, and fatigue time (P < 0.05). This review found that Integrated Medicine had better effects and did not increase adverse drug reactions for COVID-19. More high-quality RCTs are needed in the future.


Subject(s)
Betacoronavirus , Clinical Medicine/methods , Combined Modality Therapy/adverse effects , Combined Modality Therapy/methods , Coronavirus Infections/therapy , Medicine, Chinese Traditional/methods , Pneumonia, Viral/therapy , COVID-19 , Humans , Pandemics , SARS-CoV-2
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