Phase 4 Tuberculosis Trial, Recruiting NCT06403943 Sponsor: Beijing Chest Hospital Condition: Tuberculosis
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Phase 4 Tuberculosis Trial, Recruiting

NCT06403943
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People aged 18 to 65 years old, of any gender
  • People who have been diagnosed with pulmonary tuberculosis (TB affecting the lungs) according to a specific Chinese medical standard (WS 288-2017)
  • People who have either never received TB treatment before, or have received standard first-line TB medication (HRZE) for less than one week
  • People who show signs consistent with a Traditional Chinese Medicine pattern called "Qi and Yin deficiency," which includes at least two of these main symptoms — shortness of breath, tiredness, mental fatigue, or a weak pulse — plus at least one of these additional symptoms: coughing up blood, sweating without exertion, night sweats, poor appetite, bloating, or a red and tender tongue with thin coating
  • People who are willing to participate voluntarily, are likely to take medications as directed, and have signed a consent form agreeing to take part

Who may not be able to join:

  • People who have received similar Traditional Chinese Medicine treatment in the four weeks before joining the trial
  • People whose TB has been found to be drug-resistant or extensively drug-resistant
  • People with a known or suspected allergy or serious reaction to the trial drug or any of its ingredients, or who have a history of multiple allergies
  • People whose test results have shown non-tuberculosis bacteria growing (on more than two occasions), or who have been diagnosed with a non-tuberculosis bacterial lung infection
  • People with recurring TB, or people with a confirmed TB bacterial infection who have already received more than one week of TB treatment
  • People who also have autoimmune diseases, cancer, serious blood disorders, epilepsy, or psychiatric conditions
  • People with serious heart or brain blood vessel disease, such as severe heart failure, heart attack, or recent serious stroke (confirm with trial site)
  • People with uncontrolled high blood pressure (blood pressure at or above 160/100 mmHg at the time of joining)
  • People with poorly controlled diabetes
  • People with serious liver or kidney disease, or abnormal liver or kidney blood test results above certain levels (confirm with trial site)
  • People who have TB affecting parts of the body other than the lungs, such as lymph nodes, bones, kidneys, intestines, the nervous system, or the brain lining
  • People who have other lung conditions such as lung cancer, cysts, abscesses, scarring of the lungs, or dust-related lung diseases
  • People who are pregnant or breastfeeding
  • People living with HIV, or people who test positive for syphilis
  • People who have participated in another clinical trial within the past month (confirm with trial site regarding the exact timeframe)
  • People with a history of alcohol or drug abuse, or any tendency toward dependence on substances
  • People whom the research team considers unsuitable for the trial for any other reason

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: WENJUAN NIE, DR, Beijing Chest Hospital

Phone: +86 10 89509331

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Sponsor
Beijing Chest Hospital
Registry
ClinicalTrials.gov
Start date
29 May 2023
Est. completion
31 October 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Primary Outcome: Improvement of symptoms

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov