Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children

• Status: Recruiting
• Trial end date: 2022-04-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tasly Pharmaceutical Group Co., Ltd

Criteria

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 clinical trial.