Efficacy and safety of Xingbei Zhike granules in treatment of post-infectious cough (Wind-heat Invading the Lung Syndrome): A multicenter, randomized, double-blind, placebo-controlled trial
- Conditions
- post-infectious cough
- Registration Number
- ITMCTR2000004063
- Lead Sponsor
- Guangdong Province Hospital of Traditional Chinese Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients meet the diagnosis standard of post-infectious cough;
(2) The TCM classification is Wind-heat Invading the Lung Syndrome;
(3) Scores of cough >=3 (during day and night);
(4) Aged 18 to 65 years old (including 18 and 65 years old);
(5) Patients have been fully informed and voluntarily signed the informed consent.
(1) Patients with gastroesophageal reflux disease, cough variant asthma, eosinophilia bronchitis, bronchiectasis, bronchial asthma or chronic obstructive pulmonary disease;
(2) White blood cell count >12*10^9/L, and neutrophil greater than ULN;
(3) Patients with cardio-cerebrovascular, liver, kidney, or hematological disease, or other serious primary diseases. ALT or AST> 1.5 ULN, serum creatinine > 1.5 ULN;
(4) Suspected or proven history of alcohol or drug abuse, or a person with a mental illness;
(5) Pregnant or lactating women, or women who have birth plan;
(6) Allergic constitution or be allergy to the drug composition used in the trial;
(7) patients who is participating or participated in last 3 months in other drug clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Area under the curve of visual analogue scale (VAS) for cough symptoms;
- Secondary Outcome Measures
Name Time Method The total amount and times of alleviating drug use;Scores of cough symptom;Scores of Leicester Cough Quality of Life Questionnaire(LCQ);Duration for cough to disappea;The TCM scores;Disappearance rate of individual symptoms;Disappearance rate of cough symptoms;