Status:
COMPLETED
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
Lead Sponsor:
Tasly Pharmaceutical Group Co., Ltd
Conditions:
Cough
Eligibility:
All Genders
6-14 years
Phase:
PHASE2
Brief Summary
This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children.
Detailed Description
Susu used to be a clinical experienced Chinese herb formula for treating acute cough caused by common cold. The ingredients includes Hua Ju Hong, Qiao Rui Su, Zi Su Ye, Jie Geng, Gan Cao,which relievi...
Eligibility Criteria
Inclusion
- Diagnosed as common cold standard, and VAS score of daytime or night-time cough \>= 40mm;
- Diagnosed as wind cold cough syndrome;
- Aged 6-14 ( \< 14) years;
- The course of cough is \<= 48 hours;
- The maximum temperature is \<= 38 degree C within 24 hours before visit;
- The informed consent process complies with the requirement,and the legal representative and the child (\>= 8 years old) sign the informed consent form.
Exclusion
- Accompanied by sore throat, obvious fever;
- The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
- With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
- Acute bronchitis, pneumonia have been cured less than 8 weeks;
- With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
- Patients with severe malnutrition;
- Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders;
- Allergic to the experimental drugs;
- Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment;
- The investigator considers it inappropriate to participate in this clinical trial.
Key Trial Info
Start Date :
September 19 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 24 2022
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT04457011
Start Date
September 19 2020
End Date
February 24 2022
Last Update
September 5 2024
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, China, 361001
2
Hubei Provincial Hospital of TCM
Wuhan, Hubei, China, 430073
3
The First Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, China, 410007
4
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, China, 200071