REspiratory diSEAse cohoRt Studies of CHinese Medicine for ILD (RESEARCH-ILD)

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHenan University of Traditional Chinese Medicine

About this trial

This study is a traditional Chinese medicine cohort for interstitial lung disease(ILD) in China, including at least 5000 patients with ILD and followed up for at least 5 years. The aim is to focus on the demographic characteristics, clinical features, disease occurrence and development characteristics, TCM syndrome evolution patterns, and clinical efficacy of TCM treatment for ILD in the real world.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients who meet the diagnosis of ILD;

Age≥18 years old;

Ability to provide independent informed consent.

Disqualifiers

None

Trial population

Interstitial lung disease (ILD) is a group of lung diseases characterized by inflammation and/or fibrosis of the lung parenchyma, often accompanied by progressive respiratory distress, which may ultimately lead to end-stage respiratory failure.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

5,000 Participants
are grouped into 2 trial groups
Group A: Traditional Chinese Medicine cohort
Group B: Non Traditional Chinese Medicine cohort

Trial outcomes

Primary outcomes

1

All-cause mortality

The all-cause mortality will be recorded.

Time frame
up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.
2

Lung transplantation

The lung transplantation will be calculated in each cohort at the end of the trial.

Time frame
Up to week 13, 26, 39, 52, 65, 78 ,91 and 104 weeks.

Secondary outcomes

1

Frequencies of acute exacerbations (AEs)

The frequencies of acute exacerbations (AEs) will be recorded. The diagnostic criteria for acute exacerbation refer to the 2016 international consensus and the 2019 Chinese expert consensus.

Time frame
The frequencies of acute exacerbations at weeks 13, 26, 39, 52, 65, 78, 91 and 104.
2

Proportion of progressive-free survival

The Proportion of progressive-free survival will be recorded.The disease progression criteria refer to the relevant provisions of the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guidelinefor PPF, including deterioration of respiratory symptoms, physiological evidence of disease progression, and radiological evidence.

Time frame
The Proportion of progressive-free survival at weeks 13, 26, 39, 52, 65, 78, 91 and 104.
3

6 Six Minute Walk Distance(6MWD)

6MWD will be applied to evaluate the exercise capacity. The higher values indicate the better exercise capacity.

Time frame
Change from baseline 6MWD at week 13, 26, 39, 52, 65, 78, 91 and 104.
4

Pulse Oxygen Saturation(SPO2)

Before and after the 6-minute walk test, blood oxygen saturation (SPO2) will be detected through a pulse oximeter monitor.

Time frame
Change from baseline SPO2 at week 13, 26, 39, 52, 65, 78, 91 and 104.

Other outcomes

Sponsors and contacts

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