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Tongsai granule for syndrome of phlegm heat obstructing lung in acute exacerbation of chronic obstructive pulmonary disease: a pilot study

Tongsai granule for syndrome of phlegm heat obstructing lung in acute exacerbation of chronic obstructive pulmonary disease: a pilot study

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100042444
Enrollment
Unknown
Registered
2021-01-21
Start date
2021-02-01
Completion date
Unknown
Last updated
2021-04-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic obstructive pulmonary disease

Interventions

Sponsors

The First Affiliated Hospital of He'nan University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Patients who are diagnosed with moderate to severe AECOPD; (2) Patients who meet the Chinese medicine syndrome classification of phlegm heat obstructing lung; (3) Patients who are aged 40–80 years; (4) Patients who do not participate in other interventional trials in the past month; (5) Patients who sign the written informed consent form.

Exclusion criteria

Exclusion criteria: (1) Patients who are pregnant or lactating; (2) Patients who are unable to communicate; (3) Patients who have heart failure (NYHA Class IV), severe cardiac arrhythmias,or unstable hemodynamics; (4) Patients who have bronchiectasis, active tuberculosis, pneumothorax, pleural effusion, pulmonary thromboembolic, or neuromuscular diseases affecting respiratory movement function; (5) Patients who have a history of tumor; (6) Patients who have been treated for more than seven days outside the hospital; (7) Patients who require invasive mechanical ventilation; (8) Patients who have severe liver or kidney disease; (9) Patients who require long-term bed rest; (10) Patients who have known hypersensitivity to the study medication or some of its ingredients.

Design outcomes

Primary

MeasureTime frame
Duration from admission to the time meeting discharge criteria;Clinical COPD questionnaire (CCQ);

Secondary

MeasureTime frame
Clinical symptoms and signs scores;mMRC;Frequency and severity of acute exacerbation;The time to the first acute exacerbation;COPD assessment test (CAT);mPRO-COPD;mESQ-COPD;Arterial blood gas analysis;

Countries

China

Contacts

Public ContactJiajia Wang

He'nan University of Chinese Medicine

wangiahn@163.com+86 371-66248624

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026