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A Randomized Double-Blind Controlled Clinical Trial of Wenyang Jiedu Tongluo Formula in the Peri-Discharge Management of Chronic Obstructive Pulmonary Disease

A Randomized Double-Blind Controlled Clinical Trial of Wenyang Jiedu Tongluo Formula in the Peri-Discharge Management of Chronic Obstructive Pulmonary Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000831
Enrollment
Unknown
Registered
2026-03-31
Start date
2026-04-15
Completion date
Unknown
Last updated
2026-04-28

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Interventions

Experimental Group:Conventional Western treatment + Wenyang Jiedu Tongluo Formula granules
Control Group:Conventional Western treatment + Placebo granules

Sponsors

China Academy of Chinese Medical Sciences, Xiyuan Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1)Meet Western diagnostic criteria for COPD; 2) In peri-discharge period of COPD; 3) TCM pattern of lung-kidney yang deficiency with blood stasis and toxin retention; 4) Age =40 and =80 years; 5) Willing to participate and sign informed consent.

Exclusion criteria

Exclusion criteria: 1)BODE index =7; 2) Allergy to trial drugs; 3) Liver function abnormalities (ALT/AST/GGT/ALP/TBIL/DBIL >1.5×ULN) or renal dysfunction (Scr >ULN); 4) Severe cardiovascular/cerebrovascular diseases, hematological disorders, malignancies; 5) Mental illnesses; 6) Pregnant/lactating women; 7) Other unsuitable conditions per researchers.

Design outcomes

Primary

MeasureTime frame
The number of acute exacerbations and readmissions due to acute exacerbations in patients with Chronic Obstructive Pulmonary Disease during the peri-discharge period;—

Secondary

MeasureTime frame
time interval from discharge to first acute exacerbation and duration of acute exacerbation;Number of acute exacerbations and readmissions due to acute exacerbations from the peri-discharge period to 6 months;Pulmonary Function;Exhaled nitric oxide;Chronic Obstructive Pulmonary Disease Assessment Test Score;Modified Medical Research Council dyspnea scale;Transitional/Baseline Dyspnea Index;Chronic Obstructive Pulmonary Disease Patient Frailty Assessment: Fried Frailty Phenotype;Nutritional Status Assessment: Geriatric Nutritional Assessment Form;Traditional Chinese Medicine Syndrome Score;Body mass index, Airflow obstruction, Dyspnea, Exercise capacity index;—

Countries

China

Contacts

Public ContactFan Maorong

China Academy of Chinese Medical Sciences, Xiyuan Hospital

fanmr1974@qq.com13621077946

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: May 1, 2026