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A randomized, placebo-controlled, double-blind, and multi-center clinical study observing the efficacy and safety of Xuanfeizhisuheji for acute bronchitis and post-infection cough(syndrome of wind evil invading lung)

A randomized, placebo-controlled, double-blind, and multi-center clinical study observing the efficacy and safety of Xuanfeizhisuheji for acute bronchitis and post-infection cough(syndrome of wind evil invading lung)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053411
Enrollment
Unknown
Registered
2021-11-20
Start date
2021-11-22
Completion date
Unknown
Last updated
2024-03-04

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

Conditions

Acute bronchitis, cough after infection (wind evil invading lung syndrome)

Interventions

test group:Xuanfeizhisuheji
control group:Xuanfeizhisuheji placebo

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: Acute bronchitis group was included in the criteria: 1. Patients diagnosed with acute bronchitis in Western medicine; 2. Patients diagnosed with Syndrome Of Wind Evil Invading Lun in TCM; 3. Patients with no gender limitation, aged between 18 and 75 years old (including endpoint values); 4. Those who voluntarily participated in the study and signed the informed consent form. PIC groups were included in the criteria: 1.Patients diagnosed with Post-infection cough in Western medicine; 2.Patients diagnosed with Syndrome Of Wind Evil Invading Lun in TCM; 3. Patients with no gender limitation, aged between 18 and 75 years old (including endpoint values); 4. Those who voluntarily participated in the study and signed the informed consent form.

Exclusion criteria

Exclusion criteria: Exclusion criteria for the acute bronchitis group: 1.Chronic respiratory diseases such as lung cancer, COPD, tuberculosis and asthma; 2.Present in patients of Body temperature> 38.0 degree, with lower respiratory tract infections such as acute aggravation of chronic bronchitis, acute aggravation of bronchiectasis, bronchopneumonia and etc.; 3. Patients with severe primary diseases of cardiovascular, liver, renal and hematopoietic system (blood ALT and AST exceed the upper limit of normal value by 2 times; blood creatinine exceeds the upper limit of normal value); 4.Patients with allergic constitution; 5.Women with pregnancy, lactation or those with family planning within the past 3 months; 6. Patients who have taken similar drugs to the test drugs in the past 2 weeks; 7. Have received or are receiving other drug clinical investigators within the 3 months prior to participating in this study; 8. The investigator is not suitable to participate in clinical investigators (such as patients with poor compliance). Exclusion criteria for PIC group: 1.Chronic respiratory diseases such as lung cancer, COPD, tuberculosis and asthma; 2. Patients with severe primary diseases of cardiovascular, liver, renal and hematopoietic system (blood ALT and AST exceed the upper limit of normal value by 2 times; blood creatinine exceeds the upper limit of normal value); 3.Patients with allergic constitution; 4.Women with pregnancy, lactation or those with family planning within the past 3 months; 5. Patients who have taken similar drugs to the test drugs in the past 2 weeks; 6. Have received or are receiving other drug clinical investigators within the 3 months prior to participating in this study; 7. The investigator is not suitable to participate in clinical investigators (such as patients with poor compliance).

Design outcomes

Primary

MeasureTime frame
Time of cough relief and disappearance;response rate;Cough visual analogue VAS score;liver function;renal function;(body) temperature;heart rate;blood pressure;Pulmonary ventilation examination;

Secondary

MeasureTime frame
Leicester Cough Quality of Life Questionnaire;Traditional Chinese Medicine Syndrome Score Scale;

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

zryygcp@163.com+86 10 84205227

Outcome results

None listed

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