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An Interventional Cohort Study of Feiwei Decoction Based on the Theory of Treating Different Diseases with the Same Therapy for Interstitial Lung Disease with Qi Deficiency and Blood Stasis Syndrome

An Interventional Cohort Study of Feiwei Decoction Based on the Theory of Treating Different Diseases with the Same Therapy for Interstitial Lung Disease with Qi Deficiency and Blood Stasis Syndrome

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300075982
Enrollment
Unknown
Registered
2023-09-21
Start date
2023-10-01
Completion date
Unknown
Last updated
2023-09-26

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

Conditions

Interstitial Lung Disease (ILD)

Interventions

Control Groups : Western medical treatment (oxygen, glucocorticoids, immunosuppressants, anti-fibrotic drugs, etc.) is given accordingly according to guideline criteria.
Treatment Groups:Feiwei Decoction + Western medical treatment (oxygen, glucocorticoids, immunosuppressants, anti-fibrotic drugs, etc.) is given accordingly according to guideline criteria.

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: (1) Subjects voluntarily participate in this study and sign a written informed consent prior to entering the study; (2) Male or female subjects aged = 18 years; (3) Evaluation of HRCT completed during screening or within 12 months prior to screening, meeting Western medical diagnostic criteria for ILD; (4) Comply with the Chinese medicine diagnostic criteria for consumptive lung disease with qi deficiency and blood stasis syndrome; (5) Subjects with stable disease and mild to moderate pulmonary impairment (FVC%: 50%-80%, TLC%: 30%-80%, DLCO%: 40%-80%); (6) 6WMT = 100 m without adjunctive support.

Exclusion criteria

Exclusion criteria: (1) Allergic reaction to the drugs applied in this study; (2) Scheduled for lung transplantation within 6 months; (3) Patients who are participating in other drug clinical trials or interventional studies; (4) Combination of clinically significant respiratory diseases other than ILD (e.g., asthma, chronic obstructive pulmonary disease, lung cancer, active tuberculosis, bronchiectasis, pulmonary hypertension, etc.) (5) Combination of serious life-threatening diseases of the heart, brain, liver, kidney, and hematopoietic system, as evidenced by: ?heart: New York Heart Association (NYHA) cardiac function class III-IV; ? kidney: renal insufficiency or history of renal injury; or creatinine clearance 10%)]; (6) Those who have undergone chest, abdominal, and ophthalmic surgery in the last 3 months; (7) Women who are pregnant, lactating, or planning to become pregnant; (8) Patients with mental illness.

Design outcomes

Primary

MeasureTime frame
Forced Vital Capacity, FVC;

Secondary

MeasureTime frame
Degree of difficulty breathing;quality of life;Gastroesophageal reflux condition;Traditional Chinese Medicine Syndrome Points;6-minute walk test;Arterial blood gas/fingertip oxygen saturation;

Countries

China

Contacts

Public ContactGuiling Han

China-Japan Friendship Hospital

hjxdehan@163.com+86 135 2048 0046

Outcome results

None listed

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