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EGCG 300 mg for Idiopathic Pulmonary Fibrosis

Phase 1

Recruiting

Led By Fernando Martinez, MD

Research Sponsored by Hal Chapman

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to 12 weeks

Awards & highlights

Study Summary

"This trial aims to see if a specific type of imaging test using a collagen-targeted PET probe can help understand the effects of a drug called EGCG and determine the right dosage to use."

Who is the study for?

This trial is for individuals with Pulmonary Fibrosis or Idiopathic Pulmonary Fibrosis. Specific eligibility criteria are not provided, but typically participants would need to meet certain health standards and may be required to have a confirmed diagnosis of the conditions mentioned.Check my eligibility

What is being tested?

The study is testing the effects of EGCG at two different doses (300 mg and 600 mg) compared to placebos. It uses a PET imaging probe called Gallium-68 (68Ga)-CBP8 to see if it can show how well EGCG works in treating fibrosis and help choose the right dose.See study design

What are the potential side effects?

While specific side effects are not listed, EGCG is generally considered safe with possible mild side effects like stomach upset or constipation. The PET imaging agent used may cause allergic reactions or discomfort at the injection site.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to 12 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to 12 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to 12 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in collagen probe uptake over the entire lungs

Other outcome measures

Change in peak enhancement over the entire lungs

Change in the area under the curve at 60 seconds over the entire lungs

Change in the full width at half maximum over the entire lungs

+2 more

Trial Design

4Treatment groups

Active Control

Placebo Group

Group I: EGCG 300 mgActive Control2 Interventions

Patients enrolled in this group will be given oral capsule EGCG 300 mg daily with doctor provided anti-fibrotic for 12 weeks.

Group II: EGCG 600 mgActive Control2 Interventions

Patients enrolled in this group will be given oral capsule EGCG 600 mg daily with doctor provided anti-fibrotic for 12 weeks.

Group III: Placebo for EGCG 300 mgPlacebo Group2 Interventions

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 300 mg EGCG.

Group IV: Placebo for EGCG 600 mgPlacebo Group2 Interventions

Patients enrolled in this group will be given oral capsule Placebo daily for 12 weeks with doctor provided anti-fibrotic. The number of placebo capsules will be equal to that of 600 mg EGCG.

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Cornell UniversityOTHER

166 Previous Clinical Trials

14,089,838 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

50 Patients Enrolled for Idiopathic Pulmonary Fibrosis

National Heart, Lung, and Blood Institute (NHLBI)NIH

3,840 Previous Clinical Trials

47,852,102 Total Patients Enrolled

22 Trials studying Idiopathic Pulmonary Fibrosis

4,579 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Massachusetts General HospitalOTHER

2,934 Previous Clinical Trials

13,198,559 Total Patients Enrolled

2 Trials studying Idiopathic Pulmonary Fibrosis

150 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current number of individuals being admitted into this research investigation?

"Affirmative. The information available on clinicaltrials.gov highlights that this investigation is currently seeking suitable candidates. Initially shared on February 7th, 2024, the trial details were last revised on February 9th, 2024. A total of 22 participants are being sought from a single designated site."

Answered by AI

Are potential participants currently able to apply for enrollment in this trial?

"Affirmative. Information on clinicaltrials.gov states that this medical investigation is presently seeking suitable participants. The initial posting date was 2/7/2024, and the most recent revision occurred on 2/9/2024. This study aims to enroll 22 individuals at a single site."

Answered by AI

Is the research study open to participants who are younger than 18 years old?

"Potential participants eligible for this research must be aged between 40 and 85 years. There are no ongoing studies for individuals under 18, but there are 104 trials catering to those above the age of 65."

Answered by AI

Would it be possible for me to participate in this medical study?

"Individuals aged between 40 and 85 with a diagnosis of idiopathic pulmonary fibrosis are eligible to participate in this study, which aims to enroll approximately 22 individuals."

Answered by AI

What are the potential risks associated with consuming EGCG at a dosage of 300 mg for individuals?

"Our team at Power has evaluated the safety of EGCG 300 mg to be a score of 1 on our scale. This assessment is based on this being a Phase 1 trial with limited existing data supporting both its effectiveness and safety profiles."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect

Hal Chapman 2024. "Collagen-targeted Positron Emission Tomography (PET) Imaging for Assessment of EGCG Effect". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06265532.

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