Multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of Xifeining Tablets in the treatment of idiopathic pulmonary fibrosis (IPF)

Multicenter, randomized, double-blind, placebo-controlled clinical study on the efficacy and safety of Xifeining Tablets in the treatment of idiopathic pulmonary fibrosis

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025002407

Enrollment

Unknown

Registered

2025-12-06

Start date

2025-12-08

Completion date

Unknown

Last updated

2026-01-12

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

Conditions

Idiopathic Pulmonary Fibrosis (IPF)

Interventions

Experimental Group:Oral Xifeining Tablets, 4 tablets each time, three times daily

Control Group:Oral Xifeining placebo tablets, 4 tablets each time, three times daily

Eligibility

Sex/Gender

All

Age

40 Years to 100 Years

Inclusion criteria

Inclusion criteria: (1) Age =40 years, regardless of gender. (2) Diagnosed with IPF according to 2022 ATS/ERS/JPS/ALAT diagnostic guidelines. (3) TCM syndrome differentiation of phlegm-heat stasis syndrome. (4) No treatment with nintedanib or pirfenidone for at least 4 weeks before screening; or stable regimen of nintedanib/pirfenidone for at least 4 weeks before screening. (5) Screening ppFVC =45%. (6) Screening DLCO =25% of predicted value. (7) Willing to sign informed consent and comply with follow-up.

Exclusion criteria

Exclusion criteria: (1) Clinically significant airway obstruction. (2) Major lung diseases other than IPF. (3) IPF acute exacerbation within 4 months before screening. (4) Lower respiratory tract infection requiring antibiotics within 2 weeks before screening. (5) Active hepatitis/tuberculosis infection. (6) Major surgery within 3 months before screening. (7) ALT/AST >1.5×ULN or total bilirubin >1.5×ULN. (8) eGFR =45 ml/min/1.73m². (9) Malignancy history within 5 years. (10) BP =160/100 mmHg. (11) Thrombotic events within 6 months. (12) Unstable cardiac diseases. (13) Positive HBsAg/HCV antibody/syphilis/HIV. (14) Planned lung transplantation. (15) Smoking within 3 months before screening. (16) Severe depression or drug allergies. (17) Participation in other clinical trials within 3 months. (18) Pregnancy or lactation. (19) Investigator's judgment of unsuitability.

Design outcomes

Primary

Measure	Time frame
FVC;ppFVC;DLCO;6MWT;L-IPF score;TCM syndrome score;HRCT score;Acute exacerbations;Hospitalizations;Disease progression;	—

Countries

China

Contacts

Public ContactJunchao Yang

The First Affiliated Hospital of Zhejiang Chinese Medical University (Zhejiang Provincial Hospital of Traditional Chinese Medicine)

yangjunchaozj@163.com13858036093

Outcome results

None listed

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