A multicenter, prospective, randomized, double-blind, placebo-controlled clinical study of Fuzhengtongluo granules in the treatment of idiopathic pulmonary fibrosis

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2400079658

Enrollment

Unknown

Registered

2024-01-09

Start date

2024-01-14

Completion date

Unknown

Last updated

2024-01-14

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

Conditions

idiopathic pulmonary fibrosis

Interventions

Control group:Control group: Nidanib (Boehringer Ingheim, Vegat) 150mg, twice a day, swallowed with warm water. Combined with placebo 1 bag once, 2 times a day, with warm water, the course of treatmen

Trial group:Trial group: Nidanib (Boehringer Ingheim, Vegat) 150mg, swallowed twice a day with warm water. Combined Fuzheng Tongluo granule 1 bag, 2 times a day, warm water, the course of 12 weeks. Ob

Eligibility

Sex/Gender

All

Age

50 Years to 85 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria of IPF Western medicine; ? It meets the TCM diagnostic criteria of kidney deficiency and collateral-stasis type; ?Age 50-85 years old, male and female; ?50%=FVC%=90%, 30%=DLCO (corrected by hemoglobin) =90%; ? Volunteer to participate in this experiment and sign the informed consent.

Exclusion criteria

Exclusion criteria: ? Acute aggravation or late critical patients; ? Patients with serious primary diseases of cardiovascular, liver, kidney and hematopoietic system and mental illness; ? Patients with acute diseases such as other systemic infections, fever, and bleeding; ? Pregnant or lactating women; ?People who are known to be allergic to the ingredients used in the test; ? Participated in other clinical researchers in the past 3 months; ? Those who do not want to accept experimental treatment.

Design outcomes

Primary

Measure	Time frame
Force spirometry as a percentage of the estimated value (FVC%) Change from baseline;TCM syndrome integral;	—

Secondary

Measure	Time frame
High resolution traditional score;TCM single main disease score and clinical total effective rate;oxyhemoglobin saturation;six minutes walk distance,6MWD;ATAQ-IPF scale;Serum cytokine(NLRP3,caspase-1,ASC,GSDMD,IL-1ß,IL-18);	—

Countries

China

Contacts

Public ContactZhang Wei

Shuguang Hospital affiliated to Shanghai University of Traditional Chinese Medicine

zhangw1190@sina.com+86 130 2315 3956

Outcome results

None listed

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