Study of Oral Epigallocatechin-3-gallate (EGCG) in IPF Patients

Inclusion Criteria

• •1. Provision of signed and dated informed consent form.
• •2. Stated willingness to comply with all study procedures and availability for the duration of the study.
• •3. Male or female, aged 40-85 years old.
• •4. Participant has IPF satisfying the 2022 ATS diagnostic criteria, confirmed by enrolling investigator at Visit 1.
• •5. Participant must have been on a stable dose of nintedanib twice daily or pirfenidone three times daily dose for at least 12 weeks prior to baseline (Visit 2).
• •6. Participant has a FVC ≥ 50% predicted using the global lung function initiative (GLI).
• •7. Participant has a DLCO corrected for hemoglobin ≥ 35% predicted using the GLI.
• •8. Women of child bearing potential (WCBP), defined as a sexually mature woman not surgically sterilized or not post-menopausal for at least 24 consecutive months if \< 55 years or 12 months if \> 55 years, 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. Adequate methods of contraception include use of oral contraceptives or Depo-Provera, with an additional barrier method (diaphragm with spermicidal gel or condoms with spermicide), double-barrier methods (diaphragm with spermicidal gel and condoms with spermicide), partner vasectomy, and total abstinence.
• •9. Participant has a life expectancy of at least 9 months at Visit 1.
• •10. Ability to take oral medication and be willing to adhere to EGCG regimen.
• •11. Agreement to refrain from drinking green tea in excess of a cup a day or eating green tea extract for 4 weeks before baseline and during the trial.