The global coronavirus pandemic has infected nearly 659 million people and killed morethan 6.6 million in the past three years. The symptoms of in-hospital recovery are longand difficult after epidemiological infection of 2019-NCo5. 76% of the 1,733 dischargedpatients in Wuhan in 2020 still had at least one symptom of discomfort 6 months afterinfection, with fatigue or muscle weakness being the most common (63%). Foreign Research:In the United States, 15 percent of 16,091 people infected with COVID-19 in 2021 hadsymptoms that persisted two months after infection. Novel Coronavirus Infection Diagnosisand Treatment Protocol (Trial 10th Edition) For patients recovering from novelcoronavirus infection, TCM syndrome differentiation can be carried out according to theGuidelines for Home-based TCM Intervention for Patients Infected with Novel Coronavirus,and appropriate TCM prescriptions should be given for intervention.
In the past three years, the novel coronavirus pandemic has infected nearly 659 million
people and caused more than 6.6 million deaths. Due to the continuous existence of the
mutation of the novel coronavirus strain, the increased infectivity of the virus and the
persistent immune escape potential of the virus, the number of patients infected with the
novel coronavirus increased, and the infection peak followed. According to the latest
information from the press conference of the Joint Prevention and Control Mechanism of
The State Council, from December 8, 2022 to January 12, 2023, a total of 59,938 deaths
related to novel coronavirus infection occurred in medical institutions across the
country .
TCM has a history of thousands of years in the prevention and treatment of diseases and
has accumulated rich clinical experience. For example, it is recorded in the Huangdi
Neijing · Suwen that "the five epidemics are easy to be infected with each other, with no
problem of size and similar symptoms". Written in the late Eastern Han Dynasty, Treatise
on Febrile and Miscellaneous Diseases is a clinical masterpiece on the treatment of
external febrile diseases, including most acute infectious diseases, and is known as the
"ancestor of the book". By the Ming and Qing Dynasties, TCM had a more profound
understanding of infectious diseases, formed a relatively complete theoretical system of
febrile diseases, and made great achievements in the treatment of epidemics. In
traditional Chinese medicine, the novel coronavirus infection epidemic is called
"plague", "plague", "blight", etc., characterized by rapid onset and strong infectivity,
middle-aged and elderly patients are often seriously ill, and some clinical symptoms are
protracted and difficult to cure, which seriously affects the quality of life of patients
. Domestic researchers conducted a follow-up study on 1,733 patients discharged from
Wuhan Yintan Hospital between January 7 and May 29, 2020, and found that 76% of patients
with novel coronavirus pneumonia still had at least one persistent symptom 6 months after
the onset of the disease, with fatigue or muscle weakness being the most common (63%)
[4]. Foreign researchers conducted a follow-up study on 16,091 adult patients with novel
coronavirus in the United States from February 5, 2021 to July 6, 2022, and 15% of the
patients reported persisting symptoms 2 months after infection [5]. Therefore, how to
effectively delay symptoms and promote recovery is one of the key concerns in the
research field of novel coronavirus infection.
Currently recognized effective drugs for the treatment of novel coronavirus, such as
Paxlovid , Molnupiravir , Remdesivir , glucocorticoid, monoclonal antibody, etc., are
mainly used to prevent high-risk patients with novel coronavirus infection from becoming
severe or to reduce the fatality rate. However, there is still a lack of effective modern
medical treatment for promoting body recovery and improving exercise tolerance.
New York Heart Association (NYHA) cardiac function scale, dyspnea scale and other
measures to assess patients' activity ability, but such assessment measures are more
dependent on patients' subjective feelings; Objective data evaluation has more clinical
guiding value. The 6-minute walk test (6MWT) is simple, economical and safe, and can
better reflect the exercise tolerance and cardiopulmonary function of patients. It is
widely used to evaluate the efficacy and rehabilitation effect of patients with
cardiovascular diseases and chronic respiratory diseases.
Although drugs can be used for symptomatic treatment such as cough and phlegm, there is
no effective western medicine to relieve these symptoms such as fatigue, muscle weakness,
qi promotion of sweat, fear of wind and cold, loss of appetite and other symptoms. Citing
an article on the diagnosis and treatment of novel coronavirus published by Nature, a top
international scientific journal, it is believed that at the current stage, active
research and development of drugs that can alleviate symptoms of novel coronavirus
infection, promote the recovery of the disease and improve the quality of life, as well
as the diagnosis and treatment of mild to moderate novel coronavirus patients will have
huge public health benefits [7]. Jade screen, as a famous prescription for the treatment
of surface deficiency syndrome, comes from Wei Yilin's "Prescription for the effect of
the World Medicine" in the Yuan Dynasty (some researchers also believe that it comes from
Zhu Zhenheng's "Danxi Xin Method" in the Yuan Dynasty). The party has the beneficial
effect of gas-solid table stop sweat, attending table is not solid, spontaneous
perspiration evil wind, complexion white, pale tongue moss thin white, pulse vain,
run-down cou justified is susceptible to the wind. The jade screen is made of Astragalus,
fried white art and windproof. Astragalus is mainly used for spleen and lung Qi
deficiency, which is used to benefit Qi and solid surface, and is the king medicine.
White art invigorating spleen and qi, helping astragalus qi and solid surface, as
minister medicine; Windproof table and wind evil, as a tonic.
However, there are few prospective clinical intervention studies on the use of Manzhi
Guben granules for symptomatic supportive treatment during outpatient treatment of
convalescent patients with novel coronavirus infection, and there is still a lack of
high-quality clinical evidence-based medical evidence on its effectiveness in improving
exercise tolerance of convalescent patients after novel coronavirus infection. This
provides a good opportunity for the research of this project. By means of modern medical
research, it is found that the main components of Manzhi Guben granules (Yupingfeng +
Angelica sinensis) are: (1) Astragalus supplementing Qi and consolidating surface,
antiviral infection, significant stimulation of interferon system, regulating and
promoting humoral and cellular immunity; (2) Atractylodes atractylodes can nourish qi,
invigorate spleen, dry dampness, enhance cellular and humoral immunity, and promote
phagocytosis of macrophages; (3) Wind-proof and wind-dispelling, which can enhance immune
function and fight infection; (4) Angelica sinensis: It has anti-thrombotic effect,
improves blood circulation, improves coronary circulation in cardiovascular system, has
anti-inflammatory and analgesic effect, lowers blood sugar effect, and has protective
effect on lung. Some recent studies have found through modern pharmacological research
means that a variety of active compounds in the prescription of Yupingfeng can play a
role in the prevention and treatment of novel coronavirus infection through multi-target
and multi-pathway [9,10], which further provides the basic theoretical basis for the
clinical application of Manzhi Guben granules.
The research results of molecular mechanism of TCM prevention and treatment of novel
coronavirus infection and clinical efficacy observation provide certain reference for the
follow-up high-quality clinical research . The Research team has published an article in
Pharmacological Research on the diagnosis and treatment of novel coronavirus infection :
Analyzed in 2020 registered in the Chinese clinical trial registry of 130 intervention
new coronavirus infection in clinical research of traditional Chinese medicine, found
that: Single-center studies accounted for 60.8%, non-placebo controls for 86.2%,
open-label or unstated blinds for 30.8% and 60.8%, and 80.8% of clinical studies enrolled
no more than 300 patients. Therefore, high quality RCTs studies on the intervention of
traditional Chinese medicine in patients with novel coronavirus infection can not only
reflect the characteristics and advantages of traditional Chinese medicine, but also
provide reliable clinical research results, which has become the main target of current
research on the treatment of novel coronavirus infection by traditional Chinese medicine.
In summary, this study will closely focus on the effect of Manzhi Guben granules on
improving exercise tolerance of patients with novel coronavirus during recovery period. A
multicenter, randomized, double-blind, placebo-controlled high-quality clinical study was
conducted to determine the efficacy and safety of Manzhi Guben granules in exercise
tolerance recovery and symptom relief in patients infected with novel coronavirus.
Finally, it will provide some reference for clinical and basic research on the treatment
of novel coronavirus infection by Chinese patent medicine and the promotion of patients'
recovery. Ii. Overall Objectives of the Project
To evaluate the effectiveness and safety of Manzhi Guben granules in improving exercise
tolerance and promoting body rehabilitation in patients with novel coronavirus infection.
To provide reliable evidence support for the treatment and improvement of novel
coronavirus infection with Manzhi Guben granules.
Drug: Manzi Guben granules
Administration cycle of Manzhi Guben granules: 1-4 weeks; Usage: 10g once, twice a day,
washed with boiling water.
Other Name: test group
Inclusion Criteria:
1. Diagnostic criteria for convalestion-phase of COVID-19 patients: Patients with
COVID-19 have entered the convalestion-phase when they meet any of the following
criteria and other symptoms improve: 1) two consecutive negative nucleic acid tests
with Ct values ≥35; 2) The antigen test results were negative for three consecutive
days; 3) After staying at home for 7 days, the fever has subsided for more than 24
hours without using antipyretic drugs; (2) Middle-aged and elderly outpatients aged
50-80 (including 50 and 80 years old), regardless of gender; (3) The main clinical
manifestations were fatigue, shortness of breath, cough (satisfying at least two
main symptoms), and the results of 6-minute walking test were less than 80% of the
predicted value (about 450-500 meters); Can be accompanied by poor puppie full,
loose stool, light fat tongue, thin white or thin greasy moss, pulse floating, the
performance of lung qi deficiency. (4) Voluntarily participate in this clinical
study, give informed consent and sign informed consent.
Exclusion Criteria:
1. Severe and critically ill hospitalized patients with novel coronavirus infection;
(2) accompanied by tumor, immune deficiency disease; (3) The researcher thinks that
it is not appropriate to participate in this clinical research; (4) Suspected or
confirmed history of alcohol and drug abuse; (5) Known or suspected allergic history
to the study drug and its excipients; (6) participated in other clinical
investigators within 3 months before screening; (7) Patients with severe
neurological, cardiac, pulmonary, hematopoietic, endocrine, musculoskeletal motor
system and other primary diseases and mental disorders; (8) Patients with clinical
manifestations of Yin deficiency and fire flourishing (red tongue and thin pulse) or
phlegm-dampness and lung stagnation (white and greasy moss, slippery pulse strings);
(9) Life expectancy is less than 12 weeks due to underlying diseases.
Not Provided
yongan xu, doctor
13757164833
xuyongan2000@163.com
yangbo kang, master
19858878803
1179619719@qq.com
yongan xu, doctor, Study Chair
Second Affiliated Hospital, School of Medicine, Zhejiang University