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Modern in-depth research and development of large varieties of Chinese patent medicines for respiratory diseases-a study on the clinical relevance of Traditional Chinese Medicine compounds

Modern in-depth research and development of large varieties of Chinese patent medicines for respiratory diseases-a study on the clinical relevance of Traditional Chinese Medicine compounds

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084798
Enrollment
Unknown
Registered
2024-05-24
Start date
2024-05-31
Completion date
Unknown
Last updated
2024-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute exacerbation of chronic obstructive pulmonary disease

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of AECOPD in Western medicine; (2) AECOPD severity grade I-II; (3) Conforming to the TCM standard for syndrome differentiation of phlegm-heat obstructing lung; (4) Age 40-80 years old, gender is not limited; (5) Voluntarily participate in this clinical trial, give informed consent and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Combined with other serious lung diseases, such as bronchial asthma, active pulmonary tuberculosis, pulmonary embolism, pulmonary abscess, lung cancer, interstitial lung disease, pneumothorax or other air limitation diseases with known etiology and characteristic pathological manifestations; (2) Diseases associated with exertional dyspnea, such as aortic insufficiency, heart failure, pulmonary hypertension, severe anemia, myocardial infarction, etc.; (3) Serious diseases with severe cardiovascular and cerebrovascular diseases, liver, kidney, hematopoietic system and endocrine system, which are considered not suitable for participation in this study; (4) Indications of invasive mechanical ventilation and non-invasive ventilator application; (5) long-term use of systemic glucocorticoids; (6) Combined use of immunosuppressants is required; (7) Standardized oral antibiotics or intravenous antibiotics for more than 3 days in the week before screening; (8) The use of traditional Chinese medicine preparations or chemical drugs similar to the Qingjin Huatan decoction formula or the same functional indications for more than 3 days before screening; (9) ALT and AST > 1.5 times the upper limit of normal reference value or Scr > the upper limit of normal reference value; (10) Pregnant and lactating women; (11) having intellectual or mental disabilities; (12) known allergy to the basic therapeutic drug or any excipient prescribed in the protocol; (13) known to be allergic to Qingjin Huatan decoction prescription drug ingredients; (14) Have participated in or are participating in other clinical trials within the last 1 month; (15) The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Dyspnea, cough, phlegm score ;

Secondary

MeasureTime frame
Dyspnea, cough, phlegm score ;COPD Assessment Test;modified British medical research council Test;Blood inflammatory markers;TCM syndrome integral and TCM syndrome curative effect;Combination of drugs;

Countries

China

Contacts

Public ContactHongchun Zhang

China-Japan Friendship Hospital

13701226664@139.com+86 10 8420 5298

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026