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Clinical study on treating chronic cough related to idiopathic pulmonary fibrosis with Lianfei Zhike prescription

A single-center, prospective, randomized, double-blind, placebo, parallel controlled clinical study on the treatment of chronic cough associated with idiopathic pulmonary fibrosis with Lianfei Zhike prescription

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400084559
Enrollment
Unknown
Registered
2024-05-20
Start date
2024-06-01
Completion date
Unknown
Last updated
2024-05-27

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

Conditions

Chronic cough associated with idiopathic pulmonary fibrosis

Interventions

Treatment group:Lianfei Zhike prescription, 1 dose a day, divided into 2 times. The course of treatment is 28 days, with continuous medication.
Control group:Lianfei Zhike formula granule simulation, 1 dose per day, divided into 2 times. The course of treatment is 28 days, with continuous medication.

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Western medicine diagnosed IPF, and cough as the main clinical manifestations; (2) TCM syndrome differentiation for lung and kidney qi deficiency, syndrome of dissipation and loss; (3) Age 40-75 years old; (4) The lung function of the vital capacity (VC) is greater than 30% of the estimated value, while the lung carbon monoxide dispersion (DLCO) is greater than 30% of the estimated value; (5) Did not participate in other clinical researchers in the past 1 month; (6) Those who voluntarily accept clinical trials and sign informed consent.

Exclusion criteria

Exclusion criteria: (1) Exclude chronic cough caused by other factors, such as cough variant asthma, chronic bronchitis, bronchiectasis, chronic obstructive pulmonary disease, postnasal drip syndrome, gastroesophageal reflux cough, eosinophilic bronchitis, allergic cough, and use of angiotensin-converting enzyme inhibitors; (2) The absolute and relative contraindications of the 6-minute walking test were excluded, including uncontrolled acute coronary syndrome, acute heart failure, acute pulmonary embolism and pulmonary infarction, acute respiratory failure, acute infectious diseases, mental dysfunction, peripheral SpO<85% at rest, and walking dysfunction; (3) Allergic constitution or allergic to the experimental drug; (4) Patients with severe cardiovascular and cerebrovascular diseases, abnormal liver function or abnormal kidney function; (5) Patients with malignant tumor, blood system disease and mental illness; (6) Women who are pregnant or breastfeeding; (7) Other conditions deemed unsuitable by the researcher.

Design outcomes

Primary

MeasureTime frame
Cough visual analogue score;

Secondary

MeasureTime frame
Leicester cough Quality of Life Scale;TCM syndrome score;Percutaneous arterial oxygen saturation;Lung function (VC, VC%pred, DLCO, DLCO%pred), exhaled nitric oxide (FeNO);6 minutes walking test;

Countries

China

Contacts

Public ContactMiao qing

Xiyuan Hospital, China Academy of Chinese Medical Sciences

miaoqing55@sina.com+86 139 1081 2309

Outcome results

None listed

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