Randomized controlled clinical trial for the efficacy and safety of Kaihoujian inhalation for acute laryngitis
- Conditions
- acute laryngitis
- Registration Number
- ITMCTR1900002675
- Lead Sponsor
- Wangjing Hospital, China Academy of Chinese Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- Not specified
(1) Patients meets the standard of Western medicine acute laryngitis (light and moderate);
(2) Patients meets the standard of Chinese medicine of wind-heat invading lung;
(3) Aged 18 to 65 years;
(4) Patients who first visit ENT clinicians within 48 hours;
(5) Patients who signed the informed consent form.
(1) Those with a body temperature higher than 37 degree C;
(2) Those with common cold, influenza, acute tonsillitis, pharyngeal diphtheria, and Wensang's angina;
(3) Those with acute tracheal-bronchitis, pneumonia, rheumatic fever , acute glomerulonephritis, rheumatic heart disease and other diseases;
(4) Patients with severe primary diseases such as cardiovascular and endocrine or hematopoietic system and those with mental illness;
(5) Patients with abnormal liver and kidney function tests, diabetes
(6) WBC >= 1.2×10^9/L;
(7) Pregnancy (defined as positive for pregnancy test), lactating woman or birth plan within half a year;
(8) Accepted Chinese medicines or antibiotics who has similar efficacy in test drugs within 48 hours before enrollment;
(9) Those who are participating in other drug clinical trials or known to be allergic to therapeutic drugs;
(10) Those who believe that they are not suitable for the test;
(11) Patients with obvious laryngeal mucosal edema by electronic laryngoscope.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method symptoms;
- Secondary Outcome Measures
Name Time Method larynscope sign;