Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule

Last updated: November 1, 2024
Sponsor: Third Affiliated Hospital of Henan University of Traditional Chinese Medicine
Overall Status: Active - Recruiting

Phase

N/A

Condition

Pulmonary Nodules

Treatment

Traditional Chinese Medicine

Clinical Study ID

NCT06673121
RESEARCH-Pulmonary nodule
  • All Genders

Study Summary

This study is a prospective multicenter cohort study that primarily evaluates the impact of traditional Chinese medicine treatment on pulmonary nodules

Eligibility Criteria

Inclusion

Inclusion Criteria:

① Patients with pulmonary nodules and recommended for follow-up by MDT; ② Voluntarily sign the informed consent form.

Exclusion

Exclusion Criteria:

①Patients with metastatic pulmonary nodules; ②Patients with benign diseases such as pulmonary lymph nodes, hamartomas, sclerosing alveolar cell tumors, or nodules with obvious benign features such as calcification; ③Patients withserious heart, lung, liver and kidney diseases.

Study Design

Total Participants: 5000
Treatment Group(s): 1
Primary Treatment: Traditional Chinese Medicine
Phase:
Study Start date:
January 03, 2024
Estimated Completion Date:
December 30, 2029

Study Description

This study is a multicenter, prospective cohort study that will recruit at least 2244 individuals with chest HRCT findings of pulmonary nodules and recommended follow-up by MDT from four research centers. According to whether patients with pulmonary nodules are treated with traditional Chinese medicine, they are divided into a traditional Chinese medicine cohort and a non-traditional Chinese medicine cohort , and are followed up for at least 2 years. The main outcome measures were pulmonary nodule growth (enlargement or new onset) and nodule regression (reduction or disappearance). To evaluate the efficacy of traditional Chinese medicine treatment for patients with pulmonary nodules, secondary outcome measures include nodule volume, average nodule density, doubling time of volume, internal and external signs of nodules, anxiety self-assessment scale, depression self-assessment scale and SF-36 scale.

Connect with a study center

  • The Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

    Zhengzhou, Henan 450000
    China

    Active - Recruiting

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