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A multicenter prospective randomized double-blind placebo-controlled clinical study of Fuzheng Tongluo Granule in the treatment of idiopathic pulmonary fibrosis

A multicenter prospective randomized double-blind placebo-controlled clinical study of Fuzheng Tongluo Granule in the treatment of idiopathic pulmonary fibrosis

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001567
Enrollment
Unknown
Registered
2025-08-19
Start date
2024-07-10
Completion date
Unknown
Last updated
2025-09-15

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:Fuzheng Tongluo Granule
control group:Fuzheng Tongluo Granule Placebo

Sponsors

Shuguang Hospital affiliated to Shanghai University of traditional Chinese medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
50 Years to 85 Years

Inclusion criteria

Inclusion criteria: Meet the diagnostic criteria of IPF in western medicine; It meets the diagnostic criteria of traditional Chinese medicine for kidney deficiency and collateral stasis;Age is 50-85 years old regardless of sex;Negative urine pregnancy test; Volunteer to participate in this experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: Acute exacerbation or late critical patients;Patients with serious primary diseases such as cardiovascular liver kidney and hematopoietic system and mental illness;Patients with other acute diseases such as systemic infection fever and bleeding; Pregnant or lactating women;Those who are known to be allergic to the ingredients of experimental drugs;Participated in other clinical researchers in recent 3 months;Those who are unwilling to accept experimental treatment.

Design outcomes

Primary

MeasureTime frame
Percentage of forced vital capacity to predicted value;

Secondary

MeasureTime frame
Six minute walk distance;blood oxygen saturation;Diffusion capacity of nitric oxide;High resolution CT;St. George's respiratory questionnaire;The integral of TCM syndrome and single main symptom;Serum cytokines;

Countries

China

Contacts

Public ContactZhang Wei

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

1181748336@qq.com18116291642

Outcome results

None listed

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