Common cold (Wind pathogen attacking the exterior, dampness accumulation blocking the syndrome)
Conditions
Interventions
experimental group: Huoxia Cold Granules, 1 bag each time, twice a day, dissolved in boiling water for oral administration.Placebo group: Huoxia Cold Granules Analogue, 1 bag each time, twice a day, d
placebo group:Huoxia Cold Granules Analogue, 1 bag each time, twice a day, dissolved in boiling water for oral administration
Sponsors
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the Western medical diagnostic criteria for the common cold; (2) It meets the TCM diagnostic criteria for the common cold (wind pathogen attacking the exterior and dampness obstructing the middle). (3) Age: 18 to 65 years old (inclusive), gender not limited; (4) The disease course at the time of random enrollment was =48 hours; (5) Body temperature (axillary temperature) =37.3? within 24 hours before the visit; (6) At the time of random enrollment, the scores of at least two of the symptoms including headache and drowsiness, heavy limbs, nausea, poor appetite, distension and pain in the epigastrium and abdomen, and loose stools were =2 points. (7) Informed consent and signing of the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with respiratory diseases such as influenza, novel coronavirus infection, mycoplasma infection, acute viral or herpetic pharyngitis and laryngitis, acute pharyngeal conjunctivitis, acute bacterial sinusitis, acute pharyngeal tonsillitis, acute allergic rhinitis, tracheobronchitis, pneumonia, chronic cough, etc., which are evaluated by researchers as possibly affecting the therapeutic effect evaluation. (2) Those who have concurrent bacterial gastroenteritis, bacillary dysentery, infectious or allergic enteritis, functional dyspepsia, irritable bowel syndrome or other gastrointestinal diseases, or have obvious gastrointestinal symptoms before the onset of this cold. (3) Axillary temperature >38.5? during screening. (4) The white blood cell count in the blood routine test is greater than the upper limit of the normal reference value, or the percentage of neutrophils is greater than 75%, and the researcher considers it to be a bacterial infection. (5) ALT and AST > 1.5 times the upper limit of the normal reference value; Serum creatinine > the upper limit of the normal reference value; (6) Within 12 hours before screening, the applicant has used drugs for treating colds or alleviating cold symptoms, or traditional Chinese patent medicines with similar functions and indications to the test drugs. (7) If the subject suffers from severe diarrhea or high fever leading to dehydration, or is unable to eat due to gastrointestinal discomfort or vomiting, intravenous fluid replacement is required to maintain the body's basal metabolism. (8) There are other serious primary diseases of important organs such as the heart, liver, kidneys, blood system and endocrine system. (9) Pregnant or lactating women, and those who have plans to have children or are unwilling to take effective contraceptive measures within three months after the end of the trial. (10) Those who are allergic to the components of the investigational drug or emergency drugs. (11) Those who are suspected of or have a history of alcohol or drug abuse. (12) Those who have participated in other interventional clinical trials within the past three months. (13) Those who the researchers consider unsuitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effectiveness indicators:Disease recovery rate: The proportion of subjects who reach the recovery standard on the 6th day of medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Effectiveness indicators:Daily disease recovery rate: The proportion of subjects who reach the recovery standard on the 2nd, 3rd, 4th, and 5th days of medication.;Effectiveness indicators:Disease recovery time: The time required for all symptoms and signs to disappear.;Effectiveness indicators:Disappearance rate of individual symptoms: The proportion of subjects whose individual symptoms disappeared after the end of treatment.;Effectiveness indicators:Complete fever reduction time: The time when the fever disappears in the baseline fever subjects.;Effectiveness indicators:The change value and rate of the total score of TCM symptoms after the treatment compared with the baseline.;Effectiveness indicators:The therapeutic effect of TCM syndromes: The recovery rate of TCM symptoms, the more obvious rate and the total effective rate after the treatment.;Effectiveness indicators:The significant improvement rate of the overall Clinical Impression Scale - Improvement (CGI-I) score by the subjects and the study doctors: Evaluated by the subjects and the study doctors at the end of the medication.;Effectiveness indicators:The incidence of complications (acute rhinosinusitis, bronchitis, pneumonia, etc.) during the trial period.;Effectiveness indicators:The percentage of emergency drug users and the average dosage per group.; | — |
Countries
China
Contacts
Public ContactShaofeng Zhan
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Outcome results
None listed