common cold
Conditions
Interventions
Placebo group:Ganmao Qingre Granules placebo.Take 2 bags once 2 times a day and mix both bags with boiling water at the same time
High dose group:Ganmao Qingre Granules.Take 2 bags once 2 times a day and mix both bags with boiling water at the same time
Low dose group:Ganmao Qingre Granules+Ganmao Qingre Granules placebo.1 bag each time 2 times a day both bags should be taken with boiling water at the same time
Sponsors
Peking University People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: All of the following criteria must be met to be included in the test: (1) meet the Western medical diagnostic criteria for common cold; (2) Conforming to the standard of TCM wind-cold syndrome differentiation; (3)18 years old age 70 years old gender unlimited; (4) When entering the group the duration of the disease was 48 hours; (5) When entering the group the body temperature (axillary temperature) was <39; (6) Voluntary signing of informed consent.
Exclusion criteria
Exclusion criteria: Any of the following criteria can not be included in the test: (1) People who are allergic to the known components of the investigational drug or are contraindicated for emergency drug use; (2) influenza pneumonia suppurative tonsillitis acute tracheobronchitis acute viral pharyngoconjunctivitis or herpetic pharyngitis acute viral or herpetic laryngitis; (3)Other acute episodes of nasal diseases (such as allergic rhinitis chronic rhinitis acute and chronic sinusitis etc.) have previously received nasal surgery or nasopharyngeal radiotherapy nasal mucosa function abnormalities (4) Patients with chronic respiratory diseases (such as chronic obstructive pulmonary disease idiopathic pulmonary fibrosis etc.) asthma and active pulmonary tuberculosis; (5) White blood cell count>12.0 × 109/L; Or those with a neutrophil percentage greater than 80%; (6) Aspartate transaminase and/or alanine aminotransferase = 1.5 times the upper limit of normal value or serum creatinine = the upper limit of normal value and clinically significant according to the researcher's judgment; (7) Complicated with other serious primary diseases such as heart brain lung liver kidney and blood system such as diabetes viral hepatitis hemophilia or mental illness with unstable control/serious complications; (8) Those who have used Chinese and Western medicines that have a relieving effect on the common cold and its symptoms after the onset of this illness including but not limited to antibiotics antiviral drugs antihistamines steroids decongestants antipyretic and analgesic drugs cough suppressants and phlegm resolving drugs; (9) Subjects (and their partners) who have a pregnancy plan or are unwilling to take appropriate contraceptive measures within one month from enrollment to the end of the trial or who are pregnant or breastfeeding; (10) Suspected or with a history of alcohol or drug abuse; (11) Individuals who have participated in other interventional clinical trials within the previous month prior to enrollment; (12)Researchers believe that other individuals are not suitable for clinical trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Disease recovery time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The disappearance rate of all and individual symptoms after 3 and 5 days of medication;Proportion of subjects using emergency medication;Changes in Cold Symptom Score from Baseline;Total score of cold symptoms - area under the time curve;Disease recovery rate after 3 and 5 days of medication;Disease remission rate after 3 and 5 days of medication;The disappearance time of all and individual symptoms after medication; | — |
Countries
China
Contacts
Public ContactZhaolong Cao
Peking University People's Hospital
Outcome results
None listed