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Comparative Study on the Efficacy and Dose-Effect Relationship of Xiao Qinglong Decoction with Xingren and Shigao Granules versus Traditional Decoction in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Comparative Study on the Efficacy and Dose-Effect Relationship of Xiao Qinglong Decoction with Xingren and Shigao Granules versus Traditional Decoction in the Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2024000566
Enrollment
Unknown
Registered
2024-10-16
Start date
2024-10-25
Completion date
Unknown
Last updated
2026-03-02

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

Conditions

AECOPD

Interventions

Medium dosage granule group (75% of the standard dosage):On the basis of conventional Western medical treatment add medium dosage (75% of the standard dosage) formula granules.
Traditional decoction pieces group:On the basis of conventional Western medical treatment an additional Chinese herbal decoction (Xiao Qing Long Jia Xing Ren Shi Gao Tang) is administered.
Same-price granule group (33% of the standard dosage):On the basis of conventional Western medical treatment add formula granules priced equivalent to the Chinese herbal decoction (Minor Blue Dragon D
Placebo group:On the basis of conventional Western medical treatment add a placebo of Chinese herbal formula granules.
Standard dosage granule group:On the basis of conventional Western medical treatment add formula granules equivalent in dosage to the Chinese herbal decoction pieces (Xiao Qing Long Jia Xing Ren Shi G

Sponsors

Hospital of Chengdu University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Age between 40 and 80 years; (2) Meets the diagnostic criteria for the aforementioned AECOPD (without respiratory failure); (3) Requires hospitalization and is admitted within 48 hours of onset; (4) Breathlessness Cough and Sputum Scale (BCSS) score of =6 upon admission; (5) Signed informed consent.

Exclusion criteria

Exclusion criteria: (1) Shock or other hemodynamic instability; (2) Requires mechanical ventilation; (3) Concurrent active pulmonary tuberculosis lung cancer (confirmed or suspected) lung abscess; (4) Concurrent severe pulmonary organic lesions (e.g. severe bronchiectasis severe pulmonary fibrosis/cystic fibrosis/interstitial disease severe pulmonary hypertension severe obliterative bronchiolitis etc.) or other active pulmonary diseases; (5) History of lung resection or lung volume reduction surgery in the past 12 months; (6) Undergoing pulmonary rehabilitation during the study; (7) Severe heart disease history such as acute myocardial infarction congestive heart failure (NYHA class III and above) severe arrhythmia and other acute cardiac diseases; (8) Severe primary diseases of important organs and systems such as acute stroke poorly controlled hypertension active peptic ulcer diabetes (with severe complications) malignant tumors etc.; (9) Active hepatitis A hepatitis B HIV tuberculosis and infectious connective

Design outcomes

Primary

MeasureTime frame
SRT;

Secondary

MeasureTime frame
Pulmonary function indicators at 30 90 and 180 days (FVC FEV1 FEV1/FVC);Days without hospitalization within 30 90 and 180 days;Day 11 30 90 and 180 BCSS scores;Length of hospital stay and ICU stay duration;6-minute walk test (6MWT);Number of days between discharge and the next acute exacerbation;Number of acute exacerbation recurrences within 180 days;Time not taking traditional Chinese medicine during the first hospitalization;

Countries

China

Contacts

Public Contactgao peiyang

Hospital of Chengdu University of Traditional Chinese Medicine

gaopy930@126.com18980025566

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026