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Green tea compound tested for lung scarring disease

NCT ID NCT05195918

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase study tested a purified green tea extract called EGCG in 50 people with idiopathic pulmonary fibrosis (IPF) who were already taking standard medications. The main goal was to check if EGCG is safe and how it interacts with their usual drugs. Participants took EGCG or a placebo daily for 12 weeks, and researchers monitored side effects, lung function, and drug levels.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
EGCG (epigallocatechin-3-gallate), a purified green tea extract
What this could lead to
If safe and effective, EGCG could become an add-on treatment to help control idiopathic pulmonary fibrosis.
What could go wrong
This is an early Phase 1 safety study with only 50 participants, so it cannot prove whether EGCG actually helps IPF. It may also interact with standard IPF medications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

50 people

The number who actually took part.

Started

Aug 2023

Finished

Mar 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

40 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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. Exclusion Criteria: 1. AST, ALT, or direct bilirubin above upper limit normal from any cause at the Screening Visit. 2. Any history of HCV or HBV infection, NASH/NAFLD, or cirrhosis. 3. Alcohol consumption greater than 7 drinks per week. 4. Participant has emphysema ≥ 50% or the extent of emphysema is greater than the extent of fibrosis as per interpretation of Site Investigator or radiologist. 5. Participant has received investigational therapy for IPF within 4 weeks before baseline (Visit 2). 6. Participant is receiving systemic corticosteroids equivalent to prednisone \> 10 mg/day or equivalent within 2 weeks of baseline visit (Visit 2). 7. Participant has any concurrent condition other than IPF that, in the Investigator's opinion, is unstable and/or would impact the likelihood of survival for the study duration or the participant's ability to complete the study as designed, or may influence any of the safety or efficacy assessments included in the study. 8. Participant has baseline resting oxygen saturation of \< 89% on room air or need for continuous oxygen use at baseline visit (Visit 2). 9. Consumption of GTE products in excess of a cup of green tea a day within one month of the baseline visit (Visit 2). 10. Participant is receiving digoxin at the time of screening (Visit 1) and for the duration of the study. 11. Active respiratory infection requiring treatment with antibiotics within 4 weeks of the baseline visit (Visit 2). 12. Likely to be listed for transplant during trial participation.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Temple University

    Philadelphia, Pennsylvania, 19140, United States

  • UCSF Parnassus

    San Francisco, California, 94143, United States

  • University of Michigan

    Ann Arbor, Michigan, 48109, United States

  • University of Virginia

    Charlottesville, Virginia, 22908, United States

  • University of Washington

    Seattle, Washington, 98195, United States

  • Weill Cornell Medicine

    New York, New York, 10065, United States

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