Chronic Obstructive Pulmonary Disease, COPD
Conditions
Interventions
A:traditional Edible Chinese medicine-made diet + exercise training rehabilitation project
B:exercise training rehabilitation project
Sponsors
Zigong Hospital of TCM
Eligibility
Sex/Gender
All
Age
40 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) between 40 and 75 years old, male or female; 2) volunteered to participate in this study and signed informed consent; 3) according to the 2017 edition of the pulmonary function test (GOLD guide application of bronchiectasis drugs (salbutamol 400 ug or isopropyl bromide 84 ug) FEV1 ? 30% and < 80% predicted value, and FEV1 / FVC < 70%) diagnosed as stable moderate to severe COPD (grade 2 GOLD, GOLD level 3); 4) accept standard diagnosis and treatment from diagnostic and medical institutions; 5) malnutrition universal screening tool (MUST) screening for medium nutritional risk and risk of high nutritional state, and the thin body tissue index (FFMI) < normal patients; 6) TCM four diagnosis for lung spleen-deficiency syndrome differentiation type; 7) tolerance of TCM herbal treatment; 8) can tolerate exercise training. Diagnostic criteria: Western medicine standard: in accordance with the GOLD guide 2017, lung function after definite diagnosis (inhaled bronchodilator FEV1 / FVC < 0.7), limited airflow degree (FEV1 percentage of predicted value: 50-79 for GOLD grade 2; 30-49 GOLD level 3). Chronic obstructive pulmonary disease of traditional Chinese medicine of traditional Chinese medicine standard: according to "guidelines (2011 edition)". Primary symptom: (1) coughing or wheezing, shortness of breath and movement is aggravating; (2) weakness, fatigue, or the sweat and dynamic compound; (3) the evil wind, easy to catch a cold; (4) stay or eat less; (5) the diagnosis bloated with abdominal distension or loose stool; 6 tongue body fat, or have teeth marks, thin white or white greasy tongue coating, pulse heavy fine or heavy or thin.(1), (2), (3) of the two, plus the item 2 (4), (5), (6). Can be diagnosed lung spleen-deficiency type.;Inclusion criteria: 1) between 40 and 75 years old, male or female; 2) volunteered to participate in this study and signed informed consent; 3) according to the 2017 edition of the pulmonary function test (GOLD guide application of bronchiectasis drugs (salbutamol 400 ug or isopropyl bromide 84 ug) FEV1 ? 30% and < 80% predicted value, and FEV1 / FVC < 70%) diagnosed as stable moderate to severe COPD (grade 2 GOLD, GOLD level 3); 4) accept standard diagnosis and treatment from diagnostic and medical institutions; 5) malnutrition universal screening tool (MUST) screening for medium nutritional risk and risk of high nutritional state, and the thin body tissue index (FFMI) < normal patients; 6) TCM four diagnosis for lung spleen-deficiency syndrome differentiation type; 7) tolerance of TCM herbal treatment; 8) can tolerate exercise training. Diagnostic criteria: Western medicine standard: in accordance with the GOLD guide 2017, lung function after definite diagnosis (inhaled bronchodilator FEV1 / FVC < 0.7), limited airflow degree (FEV1 percentage of predicted value: 50-79 for GOLD grade 2; 30-49 GOLD level 3). Chronic obstructive pulmonary disease of traditional Chinese medicine of traditional Chinese medicine standard: according to "guidelines (2011 edition)". Primary symptom: (1) coughing or wheezing, shortness of breath and movement is aggravating; (2) weakness, fatigue, or the sweat and dynamic compound; (3) the evil wind, easy to catch a cold; (4) stay or eat less; (5) the diagnosis bloated with abdominal distension or loose stool; 6 tongue body fat, or have teeth marks, thin white or white greasy tongue coating, pulse heavy fine or heavy or thin.(1), (2), (3) of the two, plus the item 2 (4), (5), (6). Can be diagnosed lung spleen-deficiency type.
Exclusion criteria
Exclusion criteria: 1) Women who are pregnant or have no effective contraception during the observation period; 2) Patients who with allergic or allergic/hypersensitive reactions to the drug diet or any of them; 3) Patients who with pneumothorax, pleural adhesion thickening, or active pulmonary tuberculosis; 4) There has been a history of malignant tumors of any organ in the past five years (including lung cancer); 5) According to researchers, there has the clinical significance of abnormal laboratory tests, may affect patients safety or compliance, or interfere with the outcome, or affect the research completion of any situation; 6) Patients who are unwilling to participate, or the researchers said the patient could not complete the study; 7) Patients with the disease of a-1 antitrypsin deficiency; 8) Patients with asthma or higher blood eosinophilic cell count, or FeNO detection value?50 PPB. 9) Intermittent use of nasal endohormone therapy for allergic rhinitis; 10) Patients who with prolonged oxygen therapy (daily low flow absorption of >15 hours); 11) Patients who take a drug orally which is contraindicated with any ingredient in the medicinal diet; 12) During the screening period, patients who require systemic glucocorticoid combined with antibiotic treatment or hospitalization are excluded. After 4 weeks, you may consider screening again.;Exclusion criteria: 1) Women who are pregnant or have no effective contraception during the observation period; 2) Patients who with allergic or allergic/hypersensitive reactions to the drug diet or any of them; 3) Patients who with pneumothorax, pleural adhesion thickening, or active pulmonary tuberculosis; 4) There has been a history of malignant tumors of any organ in the past five years (including lung cancer); 5) According to researchers, there has the clinical significance of abnormal laboratory tests, may affect patients safety or compliance, or interfere with the outcome, or affect the research completion of any situation; 6) Patients who are unwilling to participate, or the researchers said the patient could not complete the study; 7) Patients with the disease of a-1 antitrypsin deficiency; 8) Patients with asthma or higher blood eosinophilic cell count, or FeNO detection value?50 PPB. 9) Intermittent use of nasal endohormone therapy for allergic rhinitis; 10) Patients who with prolonged oxygen therapy (daily low flow absorption of >15 hours); 11) Patients who take a drug orally which is contraindicated with any ingredient in the medicinal diet; 12) During the screening period, patients who require systemic glucocorticoid combined with antibiotic treatment or hospitalization are excluded. After 4 weeks, you may consider screening again.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| muscle strength;muscle mass;FEV1;;muscle strength;muscle mass;FEV1; | — |
Secondary
| Measure | Time frame |
|---|---|
| BMI;blood routine examination;serum albumin;6-minute walk distance;MUST;SGRQ;;BMI;blood routine examination;serum albumin;6-minute walk distance;MUST;SGRQ; | — |
Countries
China
Contacts
Public ContactWEI YAN;WEI YAN ;
Zigong Hospital of TCM;Zigong Hospital of TCM
Outcome results
None listed