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An Exploratory Clinical Study on the Treatment of Idiopathic Pulmonary Fibrosis with Shao-gan Capsules

An Exploratory Clinical Study on the Treatment of Idiopathic Pulmonary Fibrosis with Shao-gan Capsules

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300078057
Enrollment
Unknown
Registered
2023-11-28
Start date
2023-12-01
Completion date
Unknown
Last updated
2023-12-03

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

Conditions

idiopathic pulmonary fibrosis

Interventions

Experimental group:Shao-gan Capsules
Control group:Shao-gan Capsules

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: (1) Patients who meet IPF diagnosis; (2) Aged 40-85 years old; (3) Meets the diagnostic criteria for traditional Chinese medicine syndrome differentiation; (4) Not participating in clinical studies of other drugs within one month prior to enrollment; (5) Receive treatment and sign an informed consent form voluntarily.

Exclusion criteria

Exclusion criteria: (1) Patients in acute exacerbation stage; (2) Pregnant or lactating women and patients with recent pregnancy plans; (3) Patients with confusion, dementia, and various mental illnesses; (4) Patients with severe cardiac insufficiency, liver and kidney diseases (ALT, AST, BUN, Cr higher than 1.5 times the normal upper limit), bronchial asthma, COPD, connective tissue disease, and tumor; (5) Patients with severe joint, peripheral nerve, and vascular lesions that affect limb activity and long-term bed rest; (6) Known to be allergic to treatment drugs.

Design outcomes

Primary

MeasureTime frame
annual numbers of acute excerbations;6-minute walking distance;The proportion of patients with progression-free survival;

Secondary

MeasureTime frame
Pulmonary function;All-cause mortality;Clinical symptoms and signs;modified Medical Research Council(mMRC);Health-related quality of life;

Countries

China

Contacts

Public ContactShuguang Yang

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

ysg0530_0512@126.com+86 182 3715 3806

Outcome results

None listed

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