CoughPhase 3NCT05764668
Efficacy and Safety of Zihua Wenfei Granules in Treatment of Postinfectious Cough (Wind-cold Invading Lungs Syndrome)
A Phase 3 study testing Zihua Wenfei Zhisou Granule in people with Cough, run by DoCare Pharmaceutial Technology Co.,Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cough
- What is being tested?
- Zihua Wenfei Zhisou Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2022to Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
West China Hospital of Sichuan University
Chengdu, Sichuan
Bing Mao, 18980601724, maobing@medmail.com.cn
Hongli Jiang, 18980606651, doc_jhl@163.com
About this study
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
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.
Read the 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.
- Conditions
- Cough
- Being tested
- Zihua Wenfei Zhisou Granule, Placebo
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zihua Wenfei Zhisou GranuleDrug
14 daily- doses of Zihua Wenfei Zhisou Granule，one bag at a time (15 g/bag), three times/day
PlaceboDrug
14 daily- doses of placebo，one bag at a time (15 g/bag), three times/day
| Study group | Role | What they receive |
|---|---|---|
| Zihua Wenfei Zhisou Granule | Experimental | 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. Receives: Drug: Zihua Wenfei Zhisou Granule |
| Zihua Wenfei Zhisou Granule-matched placebo | Placebo comparator | 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. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cough relief rate
Cough relief refers to a 50% or more reduction in cough VAS score
Measured: day 14
Secondary outcomes (7)
Complete remission rate of cough
Complete remission of cough refers to cough VAS score<17 mm
Measured: day 14
Time to cough relief
Time to cough relief
Measured: day 14
Complete remission time of cough
Complete remission time of cough
Measured: day 14
Change from baseline in Cough Evaluation Test (CET) value
Change from baseline in Cough Evaluation Test (CET) value
Measured: day 0、day 7、day 14
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.
Measured: day 0、day 7、day 14
Change from baseline in TCM syndrome score
Change from baseline in TCM syndrome score
Measured: day 0、day 7、day 14
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.
Measured: day 0、day 14、day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start15 Nov 2022
- Primary completionNov 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- DoCare Pharmaceutial Technology Co.,Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05764668
- Sponsor's protocol ID
- KCDC-ZHWFZSKLⅢ-2022
- Status last verified
- Feb 2023
- First submitted
- 24 Feb 2023
- Last updated
- 13 Mar 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05764668
- Acronym / sponsor ID
- KCDC-ZHWFZSKLⅢ-2022
- Conditions
- Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- DoCare Pharmaceutial Technology Co.,LtdIndustry (pharma, biotech, devices)
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 13 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Zihua Wenfei Zhisou Granule | Experimental | Drug: Zihua Wenfei Zhisou GranulePatients 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. |
| Zihua Wenfei Zhisou Granule-matched placebo | Placebo comparator | Drug: PlaceboPatients 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Zihua Wenfei Zhisou Granule14 daily- doses of Zihua Wenfei Zhisou Granule，one bag at a time (15 g/bag), three times/day | Drug | Zihua Wenfei Zhisou Granule |
| Placebo14 daily- doses of placebo，one bag at a time (15 g/bag), three times/day | Drug | Zihua Wenfei Zhisou Granule-matched placebo |
Primary outcome
Cough relief rate
Time frame: day 14
Cough relief refers to a 50% or more reduction in cough VAS score
7 secondary outcomes
Complete remission rate of cough
Time frame: day 14
Time to cough relief
Time frame: day 14
Complete remission time of cough
Time frame: day 14
Change from baseline in Cough Evaluation Test (CET) value
Time frame: day 0、day 7、day 14
Change from baseline in visual analogue scale (VAS) value
Time frame: 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 Leicester Cough Questionnaire (LCQ) score
Time frame: day 0、day 14、day 28
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Zihua Wenfei Zhisou Granule in people with Cough, run by DoCare Pharmaceutial Technology Co.,Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bing Mao (18980601724, maobing@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough relief rate (time frame: day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2023.