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NCT03428412
Effects of Traditional Chinese Medicine on AECOPD Patients
Phase 3 trial testing TCM and conventional drug in Pulmonary Disease, Chronic Obstructive in 378 participants. Status unknown.
30 September 2019
Quick facts
| Lead sponsor | Henan University of Traditional Chinese Medicine |
|---|---|
| Phase | Phase 3 |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | treatment |
| Enrollment | 378 |
| Start date | 1 March 2018 |
| Primary completion | 30 September 2019 |
| Estimated completion | 31 December 2019 |
Drugs / interventions tested
- TCM and conventional drug — full drug profile →
- TCM placebo and conventional drug
Conditions studied
- Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →
- Acute Exacerbation — all drugs for Acute Exacerbation →
- Medicine, Chinese Traditional — all drugs for Medicine, Chinese Traditional →
Sponsor
Henan University of Traditional Chinese Medicine
Who can join
Adults 40 to 80, any sex, with Pulmonary Disease, Chronic Obstructive or Acute Exacerbation. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This is a multi-center, randomized, double-blind, controlled trial to compare the efficacy of two therapies for patients with AECOPD. 378 subjects will be randomly assigned to one therapies (conventional drug, and the combination of conventional drug and TCM) for 14 days treatment. After the treatment period, subjects in two arms will be followed up for 4 weeks. The primary outcomes will include COPD Assessment Test (CAT), and secondary outcomes include treatment failure rate, treatment success rate, hospitalization time, hospital admission rate, endotracheal intubation rate, mortality and quality of life (COPD-PRO, SF-36).
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Effects of Chinese Herbal Medicine on Acute Exacerbations of COPD: A Randomized, Placebo-Controlled Study.
Li J, Zhang H, Ruan H, Si Y, et al · · 2020 · cited 22× · PMID 33209019 · DOI 10.2147/copd.s276082 -
Effects of Chinese medicine on patients with acute exacerbations of COPD: study protocol for a randomized controlled trial.
Zhang H, Li J, Yu X, Li S, et al · · 2019 · cited 5× · PMID 31842969 · DOI 10.1186/s13063-019-3772-y
Verify or expand the search:
- PubMed search for NCT03428412
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Henan University of Traditional Chinese Medicine trials
Trials by the same sponsor.
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- NCT07206745 — A Study on Integrated Chinese and Western Medicine for Severe Pneumonia Caused by Multidrug-Resistant Gram-Negative Bact · NA · not yet recruiting
- NCT07178392 — Disease-syndrome Characteristics of IPF · not yet recruiting
- NCT07162870 — Idiopathic Pulmonary Fibrosis Cohort of TCM · not yet recruiting
- NCT06914713 — Jin-shui Huan-xian Formula for Retarding the Decline of Pulmonary Function in IPF · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03428412 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Henan University of Traditional Chinese Medicine
- Last refreshed: 9 February 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03428412.
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