CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 50 enrolled
Drug / intervention
EGCG 300 mg + Nintedanib +5 morecombination
Likely dose
EGCG 300 mg + Nintedanibfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05195918
NCT05195918Phase 1Completed
CompareCT.gov

Dose Ranging Study of Oral Epigallocatechin-3-gallate (EGCG) Given Daily for 12 Weeks to Patients With Idiopathic Pulmonary Fibrosis (IPF) Evaluating Safety, PK Interactions With Standard of Care Drugs, and Biomarkers of Drug Effect

Hal Chapman·interventional·Posted Jan 19, 2022·Updated Apr 14, 2026

In Brief

A Phase 1 clinical trial evaluating EGCG 300 mg + Nintedanib, EGCG 300 mg + Pirfenidone, and 4 other interventions for Idiopathic Pulmonary Fibrosis. Completed, enrolled 50 participants across 7 sites.

Detailed Summary

The primary purpose of this multi-center, double-blind, placebo-controlled, dose-ranging Phase I study is to assess the safety of a purified from green tea, EGCG, in patients with idiopathic pulmonary fibrosis (IPF) as a potential novel treatment for pulmonary fibrosis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsIdiopathic Pulmonary Fibrosis
CountriesUnited States
CollaboratorsUniversity of Michigan, Cornell University, Massachusetts General Hospital, Temple University, University of Washington, University of Virginia

Timeline

Phase 1CompletedFinished
20222023202420252026
First PostedJan 19, 2022
Enrollment StartAug 24, 2023
Primary CompletionMar 19, 2026
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 4.5 years ago

Interventions

EGCG 300 mg + Nintedanibcombination

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib

EGCG 300 mg + Pirfenidonecombination

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 300 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone

Placebo 2 capsules + Nintedanib or Pirfenidonecombination

Dietary Supplement: Placebo Placebo (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone

EGCG 600 mg + Nintedanibcombination

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Nintedanib

EGCG 600 mg + Pirfenidonecombination

Dietary Supplement: EGCG Capsules with Teavigo EGCG (at least 94% purity). 600 mg EGCG (2 capsules) taken orally daily for 12 weeks. Drug: Pirfenidone

Placebo 4 capsules + Nintedanib or Pirfenidonecombination

Dietary Supplement: Placebo Placebo (4 capsules) taken orally daily for 12 weeks. Drug: Nintedanib Drug: Pirfenidone