The Efficacy and safety evaluation of Susu Xiao'er Zhike Granules in the treatment of the cough caused by the common cold(wind cold cough syndromes) in children: a randomized, double-b
- Conditions
- Cough
- Registration Number
- ITMCTR1900002853
- Lead Sponsor
- The First Teaching Hospital of Tianjin University of TCM
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- Not specified
1. Diagnosed as common cold standard, and VAS score of daytime or night-time cough >= 40mm;
2. Diagnosed as wind cold cough syndrome;
3. Aged 6-14 ( < 14) years;
4. The course of cough is <= 48 hours;
5. The maximum temperature is <= 38 degree C within 24 hours before visit;
6. The informed consent process complies with the requirement,and the legal representative and the child (>= 8 years old) sign the informed consent form.
1. Accompanied by sore throat, obvious fever;
2. The WBC, NEU and CRP all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
3. With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
4. Acute bronchitis, pneumonia have been cured less than 8 weeks;
5. With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
6. Patients with severe malnutrition;
7. Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders;
8. Allergic to the experimental drugs;
9. Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment;
10. The investigator considers it inappropriate to participate in this clinical trial.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to Resolution of cough/ resolution rate;
- Secondary Outcome Measures
Name Time Method Disappearance rate of TCM symptom ;Overall improvement of cough;Curative effect of TCM syndrome;Area Under the cough VAS- Time Curve;Time to relief of cough;PAC-QoL scale score;