A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Qifangfeixian Granules in the Treatment of Connective Tissue Disease-Associated Interstitial Lung Disease (CTD-ILD)

Sponsor
Huilan Zhang
Study ID
NCT06674148
Phase
PHASE2/PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Interstitial Lung Disease
  • Qifangfeixian Granules

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Qifangfeixian granules — DRUG
    The experimental group was treated with Qifangfixian granules
  • Placebo — OTHER
    The control group was treated with placebo

Study Details

Interstitial lung disease (ILD) is a heterogeneous group of diseases characterized by inflammation and/or fibrinization of the alveolar unit due to a variety of known or unknown causes. CTD-ILD is one of its common categories and includes any ILD with a definite diagnosis of connective tissue disease or with a set of symptoms, signs, and abnormalities suggested by laboratory examination. The incidence of CTD-ILD varies from home to abroad. Foreign studies indicate that the number of CTD-ILD in this study accounted for 34.8% of the total number of ILD in this study, while domestic studies indicate that the number of CTD-ILD in this study accounted for 67% of the total number of ILD. At present, the treatment of CTD-ILD includes hormone, immunosuppressant cyclophosphamide, mortemycophenate, tacrolimus, etc. The above treatment has great side effects, which may increase the risk of infection and the incidence of malignant tumor. Traditional Chinese medicine has unique advantages in alleviating the clinical symptoms of the disease, reducing the use of hormones and hormone complications, and preventing infection. Qifangfeixian granule is derived from "Fangji Huangqi Decoction" in the Summary of Golden Chamber. Modern pharmacology shows that Huangqi has the functions of regulating immunity, protecting liver, antibacterial and antiviral, etc. In order to further evaluate the effectiveness and safety of using Qifangfeixian granule (Huangqi, Fangji, dogwood, dodder, ginkgo, salvia miltiorrhizae, Taoren, etc.) in the treatment of CTD-ILD patients, Determined to explore a path of CTD-ILD treatment with Chinese characteristics, we hereby apply for a multicenter controlled clinical study.

Key Dates

First listed
Nov 5, 2024
Start date
Oct 25, 2024
Status verified
Oct 2024
Primary completion
May 20, 2027
Completion
Jun 1, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Qifangfeixian granule group
    62 cases in the group , 2 times a day, each time 1 bag of Qifangfeixian granules, oral administration
  • Placebo Comparator: Placebo control group
    62 control group patients were orally administered with 1 bag of placebo twice a day

Primary Outcome Measure

forced vital capacity(FVC) [ Time Frame: 12 weeks ]

Central Contacts

Related Studies