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

Tasly Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Cough

Treatments: Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag; Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag; Drug: High dose Susu Xiao'er Zhike Granules 1 bag

Study type: Interventional

Funder types: Industry

Identifiers

NCT04457011

TSL-TCM-SSXEZKKL-Ⅱ

Details and patient eligibility

About

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.

Full 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 relieving cold and cough, resolving phlegm in traditional Chinese medicine theory. This prescription was used for a long time in clinical for treatingacute cough caused by common cold as an herb formula. To standardize the quality and make it easier to take, we reproduced it into a patent medicine and design this trial for evaluating it.

Enrollment: 240 patients

Sex: All

Ages: 6 to 14 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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240 participants in 3 patient groups, including a placebo group

High dose group

Experimental group

Description:

High dose Susu Xiao'er Zhike Granules, 1 bag, bid

Treatment:

Drug: High dose Susu Xiao'er Zhike Granules 1 bag

Middle dose group

Experimental group

Description:

Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid

Treatment:

Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag

Extremely-low dose group

Placebo Comparator group

Description:

Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid

Treatment:

Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag