- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05764668
Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome)
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Bing Mao
- Phone Number: 18980601724
- Email: maobing@medmail.com.cn
Study Contact Backup
- Name: Hongli Jiang
- Phone Number: 18980606651
- Email: doc_jhl@163.com
Study Locations
-
-
Sichuan
-
Chengdu, Sichuan, China
- Recruiting
- West China Hospital of Sichuan University
-
Contact:
- Bing Mao
- Phone Number: 18980601724
- Email: maobing@medmail.com.cn
-
Contact:
- Hongli Jiang
- Phone Number: 18980606651
- Email: doc_jhl@163.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Zihua Wenfei Zhisou Granule
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.
|
14 daily- doses of Zihua Wenfei Zhisou Granule,one bag at a time (15 g/bag), three times/day
|
Placebo Comparator: Zihua Wenfei Zhisou Granule-matched placebo
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. |
14 daily- doses of placebo,one bag at a time (15 g/bag), three times/day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cough relief rate
Time Frame: day 14
|
Cough relief refers to a 50% or more reduction in cough VAS score
|
day 14
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Complete remission rate of cough
Time Frame: day 14
|
Complete remission of cough refers to cough VAS score<17 mm
|
day 14
|
Time to cough relief
Time Frame: day 14
|
Time to cough relief
|
day 14
|
Complete remission time of cough
Time Frame: day 14
|
Complete remission time of cough
|
day 14
|
Change from baseline in Cough Evaluation Test (CET) value
Time Frame: day 0、day 7、day 14
|
Change from baseline in Cough Evaluation Test (CET) value
|
day 0、day 7、day 14
|
Change from baseline in visual analogue scale (VAS) value
Time Frame: day 0、day 7、day 14
|
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.
|
day 0、day 7、day 14
|
Change from baseline in TCM syndrome score
Time Frame: day 0、day 7、day 14
|
Change from baseline in TCM syndrome score
|
day 0、day 7、day 14
|
Change from baseline in Leicester Cough Questionnaire (LCQ) score
Time Frame: day 0、day 14、day 28
|
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.
|
day 0、day 14、day 28
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KCDC-ZHWFZSKLⅢ-2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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