← Back to Search

Polyphenol

EGCG for Pulmonary Fibrosis

Phase 1
Recruiting
Led By Harold Chapman, MD
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
Must not have
Participant has baseline resting oxygen saturation of < 89% on room air or need for continuous oxygen use at baseline visit (Visit 2)
Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 84

Summary

This trial is testing EGCG, a compound from green tea, in patients with idiopathic pulmonary fibrosis (IPF). The goal is to see if EGCG can safely reduce lung scarring. EGCG works by blocking harmful signals that cause lung tissue to harden. Epigallocatechin-3-gallate (EGCG) is a polyphenol and a major component of green tea, known for its potent antioxidant, anti-inflammatory, and anti-fibrotic properties.

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.
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.
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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I need oxygen or my oxygen levels are below 89% without it.
Select...
I have had hepatitis C or B, fatty liver disease, or cirrhosis.
Select...
I am taking more than 10 mg/day of corticosteroids or its equivalent.
Select...
I am currently taking digoxin and will continue to do so during the study.

Timeline

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

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Adverse events (AE) by causality
Change in diffusing capacity for carbon monoxide (DLCO)
Change in forced vital capacity (FVC)
+21 more
Secondary study objectives
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
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 300 mg EGCG.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include antifibrotic agents such as nintedanib and pirfenidone. Nintedanib works by inhibiting multiple tyrosine kinases involved in the pathways that lead to fibrosis, thereby slowing the progression of lung scarring. Pirfenidone exerts its effects by reducing fibroblast proliferation, collagen synthesis, and the production of pro-fibrotic cytokines. Both agents help to slow disease progression and reduce acute exacerbations, which is crucial for improving the quality of life and survival in IPF patients. Additionally, Epigallocatechin gallate (EGCG), an antioxidant and anti-inflammatory compound found in green tea, is being studied for its potential to reduce oxidative stress and inflammation, which are key contributors to the fibrotic process in IPF. These treatments are important as they target the underlying mechanisms of fibrosis and inflammation, offering hope for better disease management and outcomes for IPF patients.
Epigallocatechin-3-Gallate (EGCG), an Active Compound of Green Tea Attenuates Acute Lung Injury Regulating Macrophage Polarization and Krüpple-Like-Factor 4 (KLF4) Expression.(-)-Epigallocatechin-3-gallate Reduces Cigarette Smoke-Induced Airway Neutrophilic Inflammation and Mucin Hypersecretion in Rats.

Find a Location

Who is running the clinical trial?

University of VirginiaOTHER
785 Previous Clinical Trials
1,316,396 Total Patients Enrolled
4 Trials studying Idiopathic Pulmonary Fibrosis
2,894 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Temple UniversityOTHER
316 Previous Clinical Trials
89,257 Total Patients Enrolled
6 Trials studying Idiopathic Pulmonary Fibrosis
3,560 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of MichiganOTHER
1,862 Previous Clinical Trials
6,441,067 Total Patients Enrolled
10 Trials studying Idiopathic Pulmonary Fibrosis
12,562 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Cornell UniversityOTHER
173 Previous Clinical Trials
14,089,558 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
22 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Massachusetts General HospitalOTHER
3,026 Previous Clinical Trials
13,413,761 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
122 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Hal ChapmanLead Sponsor
2 Previous Clinical Trials
57 Total Patients Enrolled
2 Trials studying Idiopathic Pulmonary Fibrosis
57 Patients Enrolled for Idiopathic Pulmonary Fibrosis
University of WashingtonOTHER
1,828 Previous Clinical Trials
1,907,014 Total Patients Enrolled
7 Trials studying Idiopathic Pulmonary Fibrosis
1,092 Patients Enrolled for Idiopathic Pulmonary Fibrosis
Harold Chapman, MDPrincipal InvestigatorUniversity of California, San Francisco
Sydney MontesiPrincipal InvestigatorMassachusetts General Hospital
Fernando J Martinez, MDPrincipal InvestigatorCornell University
3 Previous Clinical Trials
1,283 Total Patients Enrolled
1 Trials studying Idiopathic Pulmonary Fibrosis
202 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
~26 spots leftby Apr 2026
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top