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Could a traditional chinese medicine help stop lung scarring?

NCT ID NCT07319598

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tests whether tetrandrine tablets can improve lung function in people with interstitial lung disease caused by connective tissue disease (like lupus or scleroderma). One hundred adults will receive either tetrandrine or a placebo for 24 weeks, alongside their usual treatments. The main goal is to see if the drug helps preserve breathing capacity.

What this could mean

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

Active substance
tetrandrine tablets
What this could lead to
If it works, this could provide a new treatment option to slow lung damage and improve breathing in people with connective tissue disease-related lung scarring.
What could go wrong
This is a small, early-phase (Phase 4) study with only 100 participants. The drug may not improve lung function more than placebo, and side effects are possible.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 100 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2023

Expected to finish

Jan 2027

An estimate. End dates often move.

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

18 to 80 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: * Patients who voluntarily participate and sign the informed consent form * Male or female patients aged 18-80 years (inclusive) * Patients meeting the diagnostic criteria for connective tissue disease-related interstitial lung disease per the 2018 Chinese Expert Consensus at screening * FVC ≥40% of predicted value at screening * Fertile male or female patients must agree to use effective contraception from signing informed consent until 3 months after the last study drug dose (Exemptions: postmenopausal women \>50 years with amenorrhea for \>1 year, or surgically sterilized women) * Patients on stable doses of prednisone (≤20 mg/day or equivalent) or immunosuppressants for at least 4 weeks prior to study entry, with dose adjustments not exceeding this during the double-blind period Exclusion Criteria: * Treatment with tetrandrine or other antifibrotic drugs within 1 month before screening * Diabetes with fasting blood glucose greater than 11.1 mmol per L * Resting arterial oxygen partial pressure less than 50 mmHg * Active peptic ulcers or bleeding disorders * Tumors with expected survival less than 1 year * Active pulmonary tuberculosis * Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) 5 times the upper limit of normal (ULN) or higher, or ALT or AST 3 times ULN or higher with total bilirubin 2 times ULN or higher * Creatinine clearance less than 30 mL per min (per Cockcroft-Gault formula) or patients receiving dialysis * Known allergy to tetrandrine or its excipients * Severe psychological, mental, cognitive, or intellectual impairments that may affect compliance * Pregnant or breastfeeding women, or those planning pregnancy within 3 months after the last study drug dose * Participation in another clinical trial within 3 months before screening * Patients deemed unsuitable for the study by the investigator * Clinically significant environmental exposure history that may cause pulmonary fibrosis (e.g., amiodarone, asbestos, beryllium, radiation)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Peking University Third Hospital

    RECRUITING

    Beijing, China

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