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

NCT05764668 | Unknown Phase 3

• 1 other identifier: KCDC-ZHWFZSKLⅢ-2022
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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.

Conditions

Cough

Outcome Measures

Primary Outcomes (1)

• Cough relief rate

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

  day 14

Secondary Outcomes (7)

• Complete remission rate of cough

  day 14

• Time to cough relief

  day 14

• Complete remission time of cough

  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

  day 0、day 7、day 14

Study Arms (2)

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.

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.

Drug: Placebo

Interventions

Zihua Wenfei Zhisou Granule DRUG

14 daily- doses of Zihua Wenfei Zhisou Granule，one bag at a time (15 g/bag), three times/day

Zihua Wenfei Zhisou Granule

Placebo DRUG

14 daily- doses of placebo，one bag at a time (15 g/bag), three times/day

Zihua Wenfei Zhisou Granule-matched placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• DoCare Pharmaceutial Technology Co.,Ltd: lead

Study Sites (1)

West China Hospital of Sichuan University

Chengdu, Sichuan, China

RECRUITING

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Bing Mao

CONTACT

18980601724; maobing@medmail.com.cn

Hongli Jiang

CONTACT

18980606651; doc_jhl@163.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2023
• First Posted: March 13, 2023
• Study Start: November 15, 2022
• Primary Completion: November 1, 2023
• Study Completion: August 1, 2024
• Last Updated: March 13, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)