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A randomized controlled trial for the effect of Yiqi Huayu Jiedu Recipe, with ultra-low frequency electromagnetic therapy water and infrared spectrum irradiation as adjuvant in the treatment of AECOPD

A randomized controlled trial for the effect of Yiqi Huayu Jiedu Recipe, with ultra-low frequency electromagnetic therapy water and infrared spectrum irradiation as adjuvant in the treatment of AECOPD

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022207
Enrollment
Unknown
Registered
2019-03-30
Start date
2019-04-08
Completion date
Unknown
Last updated
2020-03-23

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

Conditions

Acute exacerbation of chronic obstructive pulmonary disease

Interventions

1:Standard treatment group
2:Routine treatment of Western medicine plus traditional Chinese medicine
3:"Drinking inside and irradiating outside" plus standard treatment group
4:Traditional Chinese Medicine, Internal Drinking and External Illumination + Standard Treatment Group

Sponsors

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
19 Years to 80 Years

Inclusion criteria

Inclusion criteria: AEC0PD diagnostic criteria refers to the Chinese Experts Consensus on AECOPD Diagnosis And Treatment (revision 2017) ?The diagnosis of AECOPD is completely dependent on clinical manifestations that sudden changes in the chief symptoms (dyspnea, cough, and/or coughing phlegm) exceed the range of daily variation; ?AECOPD is a clinically excluded diagnosis. Clinical and/or laboratory tests exclude other specific diseases that can explain sudden changes in these symptoms. The diagnosis of AECOPD needs to meet ?? or ??? in (1), and ?? in (2). Traditional Chinese medicine (TCM) syndrome diagnostic criteria The TCM diagnosis of phlegm block and lung obstruction refers to the TCM Syndrome Diagnostic Criteria on AECOPD (2011) (1) Phlegm block and lung obstruction ? Coughing or gasping, short of breath ? Phlegm syndrome; ? Stomach fullness; ? Sticky mouth, dementia or lack of appetite; ? Greasy tongue,slippery pulse. The diagnosis depends on 3 symptoms from ???, and 1 symptom from ??. (2) Blood stasis as the accompanying symptom ? Dark purple in face color; ? Purple lips; ? Dark purple tongue with freckle or blemish; ? Distorted sublingual collaterals; The diagnosis depends on 1 symptom from ????. The phlegm block and lung obstruction syndrome matches with 3 symptoms from (1), as well as with 1 symptom from (2). The diagnosis was verified by 2 Chinese medicine practitioners back-to-back. Inclusion criteria (1) It conforms to the diagnostic criteria of Western medicine and traditional Chinese medicine; (2) Age: 19 =age=80 years old; (3) COPD was diagnosed for more than one year, and COPD grade in stable phase was GOLD 2017 standard grade 2 or 3 (50% less than FEV1 9.5 x 10^9/L); (7) The patients or their legal representatives understand and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Organ dysfunction parameters: oxygenation index (PaO2/FiO2) 44.2 micromol/L); coagulation dysfunction (international normalized ratio > 2.5 or activated partial thromboplastin time > 60 s); intestinal paralysis: disappearance of bowel sounds; thrombocytopenia ( 70 mmol/L); (2) Tissue perfusion parameters: hyperlactemia (>3 mmol/L); prolonged capillary refilling time or skin spots; (3) Pulmonary diseases such as pulmonary interstitial fibrosis and bronchiectasis; (4) Any hematological neoplasms (5) Heart failure (NYHA-IV); (6) Patients who need mechanical ventilation as an adjunct treatment; (7) Positive urinary pregnancy test; (8) Known or suspected to be allergic to the components of traditional Chinese medicine compound used in our institute; (9) When the local skin of the irradiated area is damaged and the patient's skin is sensitive to heat, skin allergy or skin sensory disturbance may occur. (10) Those with heart pacemaker or other medical electronic instruments embedded in the body; (11) Those whose body temperatures have been above 39.5? for 3 consecutive days or more, active pulmonary tuberculosis, severe suppurative diseases; (12) Those who have participated in other clinical studies in the past three months; (13) Those who are determined by the researchers not suitable to take part in the study group.

Design outcomes

Primary

MeasureTime frame
Blood routine + CRP;Procalcitonin;blood gas analysis;pulmonary function;Lung CT;

Countries

China

Contacts

Public ContactLi Yan

Dongzhimen Hospital, Beijing University of Traditional Chinese Medicine

13011097949@126.com+86 13011097949

Outcome results

None listed

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