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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ChiCTR |
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Last refreshed on:
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15 April 2024 |
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Main ID: |
ChiCTR2400082964 |
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Date of registration:
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2024-04-11 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Randomized Double Blind Controlled Clinical Study on the Treatment of Viral Pneumonia with Fuzheng Jiedu Formula
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Scientific title:
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A Randomized Double Blind Controlled Clinical Study on the Treatment of Viral Pneumonia with Fuzheng Jiedu Formula |
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Date of first enrolment:
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2023-06-10 |
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Target sample size:
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experimental group:120;control group:120; |
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Recruitment status: |
Recruiting |
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URL:
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https://www.chictr.org.cn/showproj.html?proj=198226 |
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Study type:
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Interventional study |
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Study design:
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Parallel
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Phase:
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0
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Countries of recruitment
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China
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Contacts
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Name:
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Luan Zheyu
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Address:
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The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Zengchan Road, Hebei District, Tianjin
301500
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Telephone:
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+86 131 6304 6162 |
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Email:
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623084194@qq.com |
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Affiliation:
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The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine |
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Name:
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Feng Jihong
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Address:
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The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine, Zengchan Road, Hebei District, Tianjin
301500
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Telephone:
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+86 138 2033 7614 |
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Email:
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1194542291@qq.com |
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Affiliation:
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The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria: (1) Those who meet the diagnostic criteria of pneumonia according to the Guidelines for the Diagnosis and Treatment of Community Acquired Pneumonia in China (2016 Edition) issued by the Respiratory Branch of the Chinese Medical Association;
(2) According to the Chinese medicine industry standards of the People's Republic of China, the Standards for the Diagnosis and Treatment of Diseases and Signs in Internal Medicine of Traditional Chinese Medicine (ZY/T001.1-94), the Guidelines for the Diagnosis and Treatment of Community acquired Pneumonia in Traditional Chinese Medicine (2018 Revision), and the Diagnosis and Treatment Plan for influenza (2020) are in line with the syndrome differentiation standards of wind warm lung fever, heat toxin Yongfei syndrome in traditional Chinese medicine;
(3) Community onset, chest imaging examination showing new patchy infiltrative shadows, consolidation shadows, ground glass shadows, or interstitial changes, with or without pleural effusion;
(4) Peripheral blood white blood cells are generally normal or low ((5) Acute onset (duration = 7 days) with 1 or more pneumonia related clinical manifestations: fever (axillary temperature>37.3 ?); Recent coughing, expectoration, or worsening symptoms of existing respiratory diseases, with or without pus/chest pain/difficulty breathing/hemoptysis; Signs of lung consolidation and/or moist rales;
(6) PSI scores ranging from II to IV;
(7) The pathogen test confirmed that the patient was infected with virus (including influenza virus, parainfluenza virus, Rhinovirus, adenovirus, novel coronavirus, human metapneumovirus, respiratory syncytial virus, etc., and any of them was positive in the pathogen test);
(8) Age 18-80 years old, regardless of gender;
(9) The subjects voluntarily joined this study and signed an informed consent form.
Exclusion criteria: (1) Patients diagnosed with acute exacerbation of chronic bronchitis, bronchiectasis, pulmonary tuberculosis, severe interstitial lung disease, and other respiratory diseases; Patients diagnosed with bronchial asthma and requiring hormone therapy;
(2) Traditional Chinese patent medicines and simple preparations or traditional Chinese medicine prescriptions whose main functions are clearing away heat, eliminating plague, detoxifying, relieving superficiality, anti-virus, strengthening the body and eliminating pathogenic factors have been clearly marked in the instructions used within 24 hours before screening;
(3) According to the diagnostic criteria for severe pneumonia in the "Guidelines for the Diagnosis and Treatment of Chinese Adult Community Acquired Pneumonia (2016 Edition)", those who meet one of the following main criteria or = three secondary criteria:
a. Main criteria: ? Mechanical ventilation treatment requires tracheal intubation;
? Septic shock still requires vasoactive drug treatment after active fluid resuscitation.
b. Secondary criteria: ? respiratory rate = 30 times/min;
? Oxygenation index = 250mmHg (1mmHg=0133kPa);
? Multiple lobar infiltration;
? Consciousness disorders and/or orientation disorders;
? Blood urea nitrogen = 7.14 mmol/L;
? Systolic blood pressure<90 mmHg requires active fluid resuscitation.
(4) With reference to the current version of Diagnosis and Treatment Plan for novel coronavirus Infection (Tenth Version for Trial Implementation), the latest version of the novel coronavirus Infection Prevention and Control Plan shall prevail. Those who meet the diagnostic criteria for severe or critical cases:
a. Severe diagnostic criteria:
Comply with any of the following:
? Suffering from shortness of breath, RR = 30 times/minute;
? In a resting state, when inhaling air, the oxygen saturation is = 93%;
? Arterial partial pressure of oxygen (PaO2)/concentration of oxygen inhalation (FiO2) = 300mmHg (1mmHg=0.133kPa); High altitude (over 1000 meters above sea level) areas should be corrected for PaO2/FiO2 according to the following formula: PaO2/FiO2 × [760/atmospheric pressure (mmHg)];
? Progressive exacerbation of clinical symptoms, with pulmonary imaging showing significant progression of the lesion within 24-48 hours exceeding 50%.
b. Diagnostic criteria for critical and severe cases:
Those who meet one of the following conditions:
? Respiratory failure occurs and mechanical ventilation is required;
? Suffering from shock;
? If combined with other organ failure, ICU monitoring and treatment are required.
(5) Merge serious diseases such as the heart, liver, kidneys, digestive system, and blood system, such as malignant tumors (excluding fully treated and completely cured skin basal cell carcinoma or squamous cell carcinoma, cervical carcinoma in situ); Acute hepatitis; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2 times the upper limit of normal value, or total bilirubin>2 times the upper limit of normal value; AST or ALT>2 times the upper limit of normal value and total bilirubin>1.5 times the upper limit of normal value; History of liver cirrhosis; Late clinical manifestations of liver disease, such as ascites or hepatic encephalopathy; Neutropenia (neutrophils<0.5 × 10^9/L); Thrombocytopenia (platelet<50 × 10^9/L); Hemophilia and other coagulation disorders; NYHA cardiac function grading = Level III; Chronic kidney disease = stage 3;
(6) Individuals who are known to be allergic to the c
Age minimum:
18
Age maximum:
80
Gender:
Both
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Health Condition(s) or Problem(s) studied
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viral pneumonia
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Intervention(s)
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experimental group:Clinical routine treatment+Fuzheng Jiedu Fang 20g/time, 2 times/day;control group:Clinical routine treatment+Fuzheng Jiedu Fang simulation agent 20g/time, 2 times/day;
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Primary Outcome(s)
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Overall remission rate of major clinical symptoms (including fever, cough, expectoration, muscle soreness, and difficulty breathing) on the day of discontinuation of medication;Overall relief time for major clinical symptoms (including fever, cough, expectoration, muscle soreness, and difficulty breathing);
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Secondary Outcome(s)
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The time for fever patients' body temperature to return to normal;The temperature normalization rate of fever patients after 3, 5, 7 days of medication and the day of discontinuation of medication;Overall disappearance rate of main clinical symptoms;Overall disappearance time of main clinical symptoms;Clinical symptom relief rate after 3, 5, and 7 days of medication use;The disappearance rate and time of individual clinical symptoms after 3, 5, 7 days of medication and on the day of discontinuation of medication;Changes in all clinical symptom scores after 3 days, 5 days, 7 days of medication, and on the day of discontinuation of medication;Improvement of Traditional Chinese Medicine Syndrome Scale scores after medication for 3 days, 5 days, 7 days, and on the day of cessation of medication;Area under symptom time curve (AUC) for all clinical symptoms and individual clinical symptom scores compared to baseline;Changes in chest imaging after discontinuation of medication;Compared to baseline, changes in inflammatory cytokines after 3 days of medication and on the day of discontinuation of medication;Changes in lymphocyte subpopulations compared to baseline after 3 days of medication and on the day of discontinuation of medication;hospital stay;Viral nucleic acid conversion rate;Secondary bacterial infection rate;Concomitant medication situation; Severe conversion rate;
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Source(s) of Monetary Support
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National key research and development program
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Ethics review
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Status: Approved
Approval date: 17/03/2023
Contact:
Gu Xufang
+86 22 6063 7912
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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