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A randomized controllde study for Bu-Shen-Yi-Qi Decoction in relieving airway hyperresponsiveness and airway inflammation in asthma patients

Integrative Chinese and Western Medicine

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900021907
Enrollment
Unknown
Registered
2019-03-15
Start date
2019-05-01
Completion date
Unknown
Last updated
2019-03-18

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

Conditions

bronchial asthma

Interventions

treatment group:ICS/LABA+Yi-Qi DecoctionBu-Shen-

Sponsors

Pu’er Hospital of traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Aged 18-75 years at the time of selection, regardless of gender; (2) Patients diagnosed as bronchial asthma by modern medicine, whose symptoms relieve and signs disappear after acute attack and reach the pre-attack level; (3) The average number of acute exacerbations in the past two years was more than 2 times per year; (4) TCM syndrome differentiation of lung and kidney qi deficiency; (5) Subjects will participate in the study voluntarily and have signed the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with bronchiectasis, active pulmonary tuberculosis, pulmonary infection, pulmonary interstitial fibrosis, pneumothorax, pleural effusion, pulmonary embolism, or neuromuscular diseases affecting respiratory motor function; (2) Patients who need long-term oral glucocorticoid or more than 3 kinds of asthma control drugs recommended by the long-term use guidelines; (3) Women who are pregnant or plan to become pregnant or lactating; (4) Patients with malignant tumors and blood diseases; (5) Have participated in the clinical trials of other drugs within 3 months; (6) Patients with severe cardiac, liver and renal function impairment (cardiac function level 3 ~ 4, ALT and/or AST exceeding 1.5 times of the normal upper limit, Cr exceeding the normal upper limit); (7) Patients suffering from rheumatic immune diseases and adrenal cortical dysfunction who need hormone and immunosuppressant; (8) Patients with fire flourishing syndrome of Yin deficiency identified by TCM; (9) Other conditions considered by the researcher not suitable for enrollment.

Design outcomes

Primary

MeasureTime frame
Frequency of acute exacerbations;Duration and degree of attack;peak expiratory flow (PEF);the average daily diurnal variation rate;Fractional exhaled nitric oxide (FENO);

Secondary

MeasureTime frame
ACT score;Quantitative scoring of TCM syndromes;Peripheral blood inflammatory markers;Inflammatory markers in induced sputum;HPA axis related markers in plasma;HPA axis related markers in saliva;

Countries

China

Contacts

Public ContactSu Mingyue
47921993@qq.com+86 15912968655

Outcome results

None listed

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