← Back to Search

Polyphenol

EGCG for Pulmonary Fibrosis

Phase 1

Recruiting

Led By Sydney Montesi

Research Sponsored by Hal Chapman

Eligibility Criteria Checklist

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

Must have

Male or female, aged 40-85 years old

Women of childbearing potential (WCBP) must have a negative serum pregnancy test within 1 week prior to the first dose of study drug and must agree to use adequate methods of birth control throughout the study

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 84

Awards & highlights

Study Summary

This trial is testing a possible new treatment for pulmonary fibrosis that uses a compound found in green tea. The goal is to find out if it's safe for humans.

Who is the study for?

This trial is for adults aged 40-85 with idiopathic pulmonary fibrosis (IPF) who meet specific lung function criteria and have been on a stable dose of nintedanib or pirfenidone. They must not drink more than a cup of green tea daily, agree to birth control if applicable, and expect to live at least 9 months. Exclusions include certain medication use, other serious health conditions, recent infections or investigational therapies.Check my eligibility

What is being tested?

The study tests the safety of EGCG from green tea in different doses combined with standard IPF treatments (nintedanib or pirfenidone) compared to placebo. It's a multi-center, double-blind trial meaning neither participants nor researchers know who gets the real treatment versus placebo.See study design

What are the potential side effects?

While side effects are being studied as part of this trial's purpose and aren't fully known yet, potential risks may include digestive issues due to oral intake of EGCG and typical side effects associated with nintedanib or pirfenidone like liver problems or photosensitivity.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 40 and 85 years old.

Select...

I am a woman who can have children, tested negative for pregnancy, and will use birth control during the study.

Select...

I can take pills and will follow the EGCG treatment plan.

Select...

My lung function is at least half of what is expected for someone my age and size.

Select...

I have been diagnosed with IPF according to the 2022 ATS criteria.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 84

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 84

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 84 for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Adverse events (AE) by causality

Change in diffusing capacity for carbon monoxide (DLCO)

Change in forced vital capacity (FVC)

+21 more

Secondary outcome measures

Change of serum biomarker COMP at day 14

Change of serum biomarker COMP at day 84

Change of serum biomarker Periostin at day 14

+3 more

Trial Design

6Treatment groups

Active Control

Placebo Group

Group I: EGCG 600 mg with NintedanibActive Control1 Intervention

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

Group II: EGCG 600 mg with PirfenidoneActive Control1 Intervention

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

Group III: EGCG 300 mg with PirfenidoneActive Control1 Intervention

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

Group IV: EGCG 300 mg with NintedanibActive Control1 Intervention

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

Group V: Placebo for EGCG 600 mgPlacebo Group1 Intervention

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

Group VI: Placebo for EGCG 300 mgPlacebo Group1 Intervention

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

Temple UniversityOTHER

297 Previous Clinical Trials

82,923 Total Patients Enrolled

6 Trials studying Idiopathic Pulmonary Fibrosis

3,562 Patients Enrolled for Idiopathic Pulmonary Fibrosis

University of MichiganOTHER

1,796 Previous Clinical Trials

6,377,906 Total Patients Enrolled

10 Trials studying Idiopathic Pulmonary Fibrosis

12,564 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Cornell UniversityOTHER

166 Previous Clinical Trials

14,089,810 Total Patients Enrolled

1 Trials studying Idiopathic Pulmonary Fibrosis

22 Patients Enrolled for Idiopathic Pulmonary Fibrosis

Media Library

Epigallocatechin-3-gallate (EGCG) (Polyphenol) Clinical Trial Eligibility Overview. Trial Name: NCT05195918 — Phase 1

Idiopathic Pulmonary Fibrosis Research Study Groups: EGCG 600 mg with Nintedanib, EGCG 600 mg with Pirfenidone, Placebo for EGCG 600 mg, EGCG 300 mg with Pirfenidone, EGCG 300 mg with Nintedanib, Placebo for EGCG 300 mg

Idiopathic Pulmonary Fibrosis Clinical Trial 2023: Epigallocatechin-3-gallate (EGCG) Highlights & Side Effects. Trial Name: NCT05195918 — Phase 1

Epigallocatechin-3-gallate (EGCG) (Polyphenol) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05195918 — Phase 1

Frequently Asked Questions

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

Who is the ideal participant for this clinical trial?

"This trial seeks to enrol 50 individuals with usual interstitial pneumonia between the ages of 40-85 years old. To qualify, applicants must: demonstrate their willingness to comply and remain available for study duration; possess a DLCO corrected for hemoglobin ≥ 35% predicted using GLI standards; provide signed and dated informed consent form; have IPF matching 2022 ATS diagnostic criteria that is confirmed by enrolling investigator at Visit 1.; be on stable dose of nintedanib or pirfenidone for minimum 12 weeks before baseline (Visit 2); have FVC ≥50% predicted via global lung function initiative (GLI) guidelines;"

Answered by AI

Are there any adverse effects associated with a combination of EGCG 300 mg and Nintedanib?

"The safety of EGCG 300 mg with Nintedanib was assessed as a 1 due to its Phase 1 status, meaning that there is limited evidence backing up both its effectiveness and security."

Answered by AI

Are there any opportunities currently to enroll in this experiment?

"Data on clinicaltrials.gov suggests that patient recruitment for this particular trial has concluded; the experiment was initially posted on March 1st of 2023 and last edited November 14th 2022. Fortunately, there are currently 410 other trials seeking participants."

Answered by AI

What outcomes is this experiment attempting to realize?

"This clinical trial, supervised for up to 12 weeks, is designed to monitor the occurrence of grade 3 or 4 treatment-emergent adverse events (TEAE). Additionally, this medical research will track shifts in serum biomarkers such as Cartilage Oligomeric Matrix Protein (COMP), Periostin and pro-MMP1 between the 3 groups."

Answered by AI