Could a traditional chinese medicine help stop lung scarring?
NCT ID NCT07319598
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Nov 2023
- Expected to finish
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Jan 2027
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Peking University Third Hospital
RECRUITINGBeijing, China
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