Reduce qi and cough dissolve phlegm and digest food. Used for phlegm dampness obstructing the lungs syndrome with symptoms such as cough wheezing or phlegm in the throat white frothy or sticky phlegm excessive phlegm in the chest and poor appetite in the epigastric region
Conditions
Interventions
Experimental group: Sanzi Zhike capsule + Xiaokechuan capsule analog agent
Control group:Xiaokechuan capsule + Sanzi Zhike capsule analog agent
Sponsors
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meets the diagnostic criteria for chronic bronchitis (simple type); (2) Meets the dialectical criteria of phlegm dampness obstructing the lungs in traditional Chinese medicine; (3) The clinical stage is acute attack phase; (4) The duration of this illness is = 3 days and the cough score is>3 points; (5) Age between 18 and 65 years old (including 18 and 65 years old) gender is not limited; (6) The percentage of forced expiratory volume in the first second to forced vital capacity (FEV1/FVC) is less than 70%; (7) Voluntarily participate in experimental research and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Individuals with axillary temperature above 38 ?; (2) The clinical evaluation of traditional Chinese medicine is for patients with lung deficiency cough, yin deficiency and excessive fire; (3) White blood cell count>12x10 ^ 9/L, neutrophil percentage>80% of the upper limit of normal values; (4) Patients diagnosed with common cold, pneumonia, bronchopneumonia, eosinophilic bronchitis, bronchial asthma, cough variant asthma, tuberculosis, lung cancer and other diseases; Acute bronchitis patients; Or individuals with other lung diseases; Individuals with a history of gastroesophageal reflux; Patients with other respiratory and nasal diseases that may cause coughing and expectoration; (5) Individuals with persistent asthma and severe hypoxia; (6) Patients with cough caused by drugs (such as angiotensin-converting enzyme inhibitors), or those who must use cough inducing drugs in combination during the trial period; (7) Individuals with severe malnutrition or a history of seizures, or those with hypertension (resting sitting systolic blood pressure = 140mmHg, diastolic blood pressure = 90mmHg), or those with hypotension (resting sitting systolic blood pressureupper limit of normal); Individuals with severe primary diseases such as cardiovascular, cerebrovascular, endocrine, and hematopoietic systems, as well as those with mental illnesses; (9) Suspected or with a history of alcohol or drug abuse; (10) Pregnant or lactating women or those with fertility plans during the study period; (11) Individuals with allergies or known allergies to the test drug; (12) Individuals who have participated in other clinical trials within the past 3 months; (13) According to the researcher's judgment, it is not appropriate for participants to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time when the cough disappears/mostly disappears(Cough score = 2 points and maintained for at least 24 hours); | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in cough scores on the 6th and 11th day after medication compared to baseline ;Curative effect of TCM syndrome on the 6th and 11th day after administration;The change values and rates of the total score of TCM syndromes and the scores of individual symptoms compared with the baseline on the 6th and 11th day after administration;The area under the AUC curve of cough score on the 6th and 11th day after administration;The change in the percentage of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) compared to baseline on day 11 after administration; | — |
Countries
China
Contacts
Public ContactWang Shuo
Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
Outcome results
None listed