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Randomized Controlled Clinical Observation of Guben Quyu Jiedu Formula in Treating Chronic Obstructive Pulmonary Disease Complicated with Frailty (Spleen-Kidney Deficiency and Stasis-Toxin Obstructing Lung)

Randomized Controlled Clinical Observation of Guben Quyu Jiedu Formula in Treating Chronic Obstructive Pulmonary Disease Complicated with Frailty (Spleen-Kidney Deficiency and Stasis-Toxin Obstructing Lung)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026001466
Enrollment
Unknown
Registered
2026-06-10
Start date
2026-06-15
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Chronic Obstructive Pulmonary Disease complicated with frailty

Interventions

experimental group:Conventional Western medicine treatment combined with traditional Chinese medicine granules of Guben Quyu Jiedu Formula
Control group:Conventional Western medicine treatment combined with simulated preparation of Guben Quyu Jiedu Formula

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
45 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Patients with stage II and III stable chronic obstructive pulmonary disease in accordance with the global initiative for chronic obstructive lung disease guidelines; (2) Fried frailty phenotype score = 3 points; (3) Patients diagnosed with spleen-kidney deficiency and stagnant toxin obstructing lung syndrome based on traditional Chinese medicine differentiation; (4) The number of severe chronic obstructive pulmonary disease exacerbations in the past year is less than 2 times per year; (5) Age ranging from 45 to 75 years old; (6) Voluntarily participate in this trial and sign the informed consent form. Note: Only patients who meet all the above conditions can be enrolled in the study.

Exclusion criteria

Exclusion criteria: (1) Those complicated with other severe primary diseases, such as severe heart disease, liver and kidney failure, hematological diseases, mental disorders and severe malnutrition, who are judged by the researchers to be influential to this clinical study; patients with severe mental and cognitive dysfunction, limited independent activities and other conditions that prevent them from cooperating to complete evaluations; (2) Patients with chronic recurrent cough and wheezing caused by non-chronic obstructive pulmonary disease factors, such as asthma, pulmonary hypertension, interstitial lung disease, pulmonary tuberculosis, bronchiectasis, heart failure, tumors, irritant gases or allergies; (3) Patients with cognitive and movement disorders who are unable to understand scale contents or finish physical fitness tests; (4) Those who are allergic or intolerant to traditional Chinese medicines, placebos or western medicine basic treatment drugs used in this research; patients receiving oral glucocorticoid therapy; (5) Those with difficulties in clinical follow-up. Note: Anyone who meets any of the above criteria shall be excluded.

Design outcomes

Primary

MeasureTime frame
Body-Mass Index, Airflow Obstruction, Dyspnea, and Exercise Capacity Index;

Secondary

MeasureTime frame
Fried Frailty Phenotype Score;Quantitative Score of Traditional Chinese Medicine Syndromes;COPD Assessment Test;Pulmonary Function Evaluation;Cr/CysC ratio;Interleukin-6;C-reactive protein;

Countries

China

Contacts

Public ContactZhang Wenjiang

Xiyuan Hospital, China Academy of Chinese Medical Sciences

13611391576@163.com13611391576

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Jun 29, 2026