Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-… (NCT04457011) | Clinical Trial Compass
CompletedPhase 2
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
China240 participantsStarted 2020-09-19
Plain-language 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.
Who can participate
Age range6 Years – 14 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 cli…
What they're measuring
1
Time to Resolution of cough/ resolution rate
Timeframe: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.