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Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome)

Primary Purpose

Cough

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Zihua Wenfei Zhisou Granule
Placebo
Sponsored by
DoCare Pharmaceutial Technology Co.,Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: When signing the informed consent form, the age is between 18 and 65 years old (including 18 and 65 years old); Diagnosis of postinfectious cough; Wind-cold invading lungs syndrome in TCM Zheng; Baseline cough visual analogue scale of 60 mm or more; Cough duration of 3- 6 weeks; Voluntarily provide written and informed consent. Exclusion Criteria: Cough caused by cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough or any other concomitant conditions; Patients with severe pulmonary diseases such as lung cancer, lung tuberculosis, or lung fibrosis; After inhaling bronchodilator, patients with FEV1/FVC<70% were excluded; Subjects who have taken angiotensin-converting-enzyme inhibitor (ACEI) in the past month; Current smokers or recent ex-smokers quitting smoking less than 3 months ago; FeNO ≥ 32 ppb or Bronchial provocation test positive (for FeNO and Bronchial provocation test, if the center cannot detect it, it can be detected in other qualified tertiary hospitals); Combined with serious cardio-cerebrovascular diseases, malignant tumors, diseases of blood and hematopoietic system, gastrointestinal diseases or other serious or progressive diseases of the system; Or those who are unable to cooperate or unwilling to cooperate due to severe mental illness, severe cognitive impairment, etc; Liver and kidney dysfunction: ALT or AST >2 times the upper limit of normal reference value; And/or serum creatinine >1.5 times the upper limit of normal reference value, or eGFR< 60 mL/min/1.73m2; White blood cell count < 3.0×109/L or > 10.0×109/L, and/or neutrophil granulocyte > 80%; Patients with temperature of 37.3℃ or above; Patients taking similar medications in the last one week; Have a long history of alcohol or drug abuse; Pregnancy or potential pregnancy or lactation; Allergic constitution or known to be allergic to any component in tested drug; Patients having participated or participating in another trial in last 3 month; Patients unsuitable for clinical trials judged by researchers.

Sites / Locations

  • West China Hospital of Sichuan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Zihua Wenfei Zhisou Granule

Zihua Wenfei Zhisou Granule-matched placebo

Arm Description

Patients in experimental treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients.

Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. Placebo does not contain active pharmaceutical ingredients, and its main ingredients are lactose, beta-cyclodextrin, stevioside, and caramel.

Outcomes

Primary Outcome Measures

Cough relief rate
Cough relief refers to a 50% or more reduction in cough VAS score

Secondary Outcome Measures

Complete remission rate of cough
Complete remission of cough refers to cough VAS score<17 mm
Time to cough relief
Time to cough relief
Complete remission time of cough
Complete remission time of cough
Change from baseline in Cough Evaluation Test (CET) value
Change from baseline in Cough Evaluation Test (CET) value
Change from baseline in visual analogue scale (VAS) value
The visual analogue scale (VAS) is a 100 mm scale, with a minimum value of 0 mm and a maximum value of 100 mm. 0 mm means that the cough is not troubled at all, and 100 mm means that the cough is the most troubled.
Change from baseline in TCM syndrome score
Change from baseline in TCM syndrome score
Change from baseline in Leicester Cough Questionnaire (LCQ) score
The LCQ comprises 19 items and takes 5 to 10 minutes to complete. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. It contains 19 items which are divided over 3 domains: physical (8 items), psychological (7 items) and social (4 items), with a 7-point Likert response scale.

Full Information

First Posted
February 24, 2023
Last Updated
March 7, 2023
Sponsor
DoCare Pharmaceutial Technology Co.,Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05764668
Brief Title
Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome)
Official Title
Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome): a Randomized, Double-blind, Placebo-controlled, Multicenter Phase III Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 15, 2022 (Actual)
Primary Completion Date
November 2023 (Anticipated)
Study Completion Date
August 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
DoCare Pharmaceutial Technology Co.,Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Cough is a common symptom of respiratory medicine clinic patients, which has complex etiology and wide-ranging. Cough is usually divided into three categories by time: acute cough, subacute cough and chronic cough. Subacute cough has a 3~8 weeks course of disease. Its main etiology is postinfectious cough, which is mostly secondary to viral infection.The drug in this study is for post-infection cough in subacute cough. After long-term clinical practice, six traditional Chinese medicines, including Aster, Lonicera japonica, Shegan, dried ginger, mango seed and Schizonepeta tenuifolia, were selected to form Zihua Wenfei Zhisou Decoction. This product has the effect of relieving wind, relieving cough, warming the lung and resolving phlegm. It can be used for the cough syndrome caused by Wind-cold invading lungs syndrome. The aim is to evaluate the efficacy and safety of Zihua Wenfei Zhisou Granule in the treatment of postinfection cough (wind-cold lung syndrome) with placebo as a control.
Detailed Description
Patients in treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day). Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. After that, there will be a follow-up 14 days after drug withdrawal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Zihua Wenfei Zhisou Granule
Arm Type
Experimental
Arm Description
Patients in experimental treatment arm were given Zihua Wenfei Zhisou Granule (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients.
Arm Title
Zihua Wenfei Zhisou Granule-matched placebo
Arm Type
Placebo Comparator
Arm Description
Patients in placebo treatment arm were given Zihua Wenfei Zhisou Granule-matched placebo (15 g/bag, one bag at a time, three times/day ). All treatment lasted for 14 days and no other antitussive/decongestant or bronchodilators are given to any patients. Placebo does not contain active pharmaceutical ingredients, and its main ingredients are lactose, beta-cyclodextrin, stevioside, and caramel.
Intervention Type
Drug
Intervention Name(s)
Zihua Wenfei Zhisou Granule
Intervention Description
14 daily- doses of Zihua Wenfei Zhisou Granule,one bag at a time (15 g/bag), three times/day
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
14 daily- doses of placebo,one bag at a time (15 g/bag), three times/day
Primary Outcome Measure Information:
Title
Cough relief rate
Description
Cough relief refers to a 50% or more reduction in cough VAS score
Time Frame
day 14
Secondary Outcome Measure Information:
Title
Complete remission rate of cough
Description
Complete remission of cough refers to cough VAS score<17 mm
Time Frame
day 14
Title
Time to cough relief
Description
Time to cough relief
Time Frame
day 14
Title
Complete remission time of cough
Description
Complete remission time of cough
Time Frame
day 14
Title
Change from baseline in Cough Evaluation Test (CET) value
Description
Change from baseline in Cough Evaluation Test (CET) value
Time Frame
day 0、day 7、day 14
Title
Change from baseline in visual analogue scale (VAS) value
Description
The visual analogue scale (VAS) is a 100 mm scale, with a minimum value of 0 mm and a maximum value of 100 mm. 0 mm means that the cough is not troubled at all, and 100 mm means that the cough is the most troubled.
Time Frame
day 0、day 7、day 14
Title
Change from baseline in TCM syndrome score
Description
Change from baseline in TCM syndrome score
Time Frame
day 0、day 7、day 14
Title
Change from baseline in Leicester Cough Questionnaire (LCQ) score
Description
The LCQ comprises 19 items and takes 5 to 10 minutes to complete. The LCQ is a validated QoL measurement tool for non-specific cough and assesses the impact of cough on various aspects of life, including emotions, sleeping behaviour, work and relationships. It contains 19 items which are divided over 3 domains: physical (8 items), psychological (7 items) and social (4 items), with a 7-point Likert response scale.
Time Frame
day 0、day 14、day 28

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: When signing the informed consent form, the age is between 18 and 65 years old (including 18 and 65 years old); Diagnosis of postinfectious cough; Wind-cold invading lungs syndrome in TCM Zheng; Baseline cough visual analogue scale of 60 mm or more; Cough duration of 3- 6 weeks; Voluntarily provide written and informed consent. Exclusion Criteria: Cough caused by cough variant asthma, upper airway cough syndrome, eosinophilic bronchitis, gastroesophageal reflux cough or any other concomitant conditions; Patients with severe pulmonary diseases such as lung cancer, lung tuberculosis, or lung fibrosis; After inhaling bronchodilator, patients with FEV1/FVC<70% were excluded; Subjects who have taken angiotensin-converting-enzyme inhibitor (ACEI) in the past month; Current smokers or recent ex-smokers quitting smoking less than 3 months ago; FeNO ≥ 32 ppb or Bronchial provocation test positive (for FeNO and Bronchial provocation test, if the center cannot detect it, it can be detected in other qualified tertiary hospitals); Combined with serious cardio-cerebrovascular diseases, malignant tumors, diseases of blood and hematopoietic system, gastrointestinal diseases or other serious or progressive diseases of the system; Or those who are unable to cooperate or unwilling to cooperate due to severe mental illness, severe cognitive impairment, etc; Liver and kidney dysfunction: ALT or AST >2 times the upper limit of normal reference value; And/or serum creatinine >1.5 times the upper limit of normal reference value, or eGFR< 60 mL/min/1.73m2; White blood cell count < 3.0×109/L or > 10.0×109/L, and/or neutrophil granulocyte > 80%; Patients with temperature of 37.3℃ or above; Patients taking similar medications in the last one week; Have a long history of alcohol or drug abuse; Pregnancy or potential pregnancy or lactation; Allergic constitution or known to be allergic to any component in tested drug; Patients having participated or participating in another trial in last 3 month; Patients unsuitable for clinical trials judged by researchers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bing Mao
Phone
18980601724
Email
maobing@medmail.com.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Hongli Jiang
Phone
18980606651
Email
doc_jhl@163.com
Facility Information:
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bing Mao
Phone
18980601724
Email
maobing@medmail.com.cn
First Name & Middle Initial & Last Name & Degree
Hongli Jiang
Phone
18980606651
Email
doc_jhl@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome)

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