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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-19

Study Completion Date

2022-02-24

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cough

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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High dose group

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

Group Type EXPERIMENTAL

High dose Susu Xiao'er Zhike Granules 1 bag

Intervention Type DRUG

High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Middle dose group

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

Group Type EXPERIMENTAL

Middle dose Susu Xiao'er Zhike Granules 1 bag

Intervention Type DRUG

Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.12 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Extremely-low dose group

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

Group Type PLACEBO_COMPARATOR

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

Intervention Type DRUG

Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 1.01 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Interventions

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High dose Susu Xiao'er Zhike Granules 1 bag

High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Intervention Type DRUG

Middle dose Susu Xiao'er Zhike Granules 1 bag

Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.12 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Intervention Type DRUG

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

Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 1.01 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

14 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No