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Respiratory Disease Cohort Studies of Chinese Medicine for Pulmonary Nodule

ConditionsPulmonary Nodule Cohort Study Traditional Chinese Medicine

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorThird Affiliated Hospital of Henan University of Traditional Chinese Medicine

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial population

Patients with pulmonary nodules have no age or gender restrictions

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Traditional Chinese Medicine
Drug
Received treatment with traditional Chinese medicine

Treatment groups

5,000 Participants

are divided into 2 treatment groups

Group A: Traditional Chinese Medicine Group1 intervention

Group B: Non-Traditional Chinese Medicine Treatment Group0 interventions

Trial outcomes

Primary outcomes

1

Pulmonary nodule growth

Enlargement of pulmonary nodules or appearance of new pulmonary nodules

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

2

Pulmonary nodule regression

Shrinkage or disappearance of pulmonary nodules

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

Secondary outcomes

1

Nodule stability

The volume change of pulmonary nodules is within ± 15%

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

2

Pulmonary nodule volume

Calculate through chest HRCT and AI analysis

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

3

Mean density of pulmonary nodules

Calculate through chest HRCT and AI analysis

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

4

Doubling time of pulmonary nodule volume

Through AI analysis and calculation

Time frame

Low risk pulmonary nodules measure at month 12, 24,36,48 and60. Medium risk pulmonary nodules measure at month 6,12,18,24,30,36,42,48,54and 60. High risk pulmonary nodules measure at 3,6,9,12,15,18,21,24,27,30, 33,36,39,42,45,48,51,54,57 and 60.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Third Affiliated Hospital of Henan University of Traditional Chinese Medicine

Lead sponsor

Source ClinicalTrials.gov