Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment

ConditionCough
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age6-13
SponsorTasly Pharmaceutical Group Co., Ltd

About this trial

To confirm the effect of Susu Xiaoer Zhike granules in treating cough caused by common cold (wind-cold cough Syndromes) in children aged 6\~13 years, shortening the course of disease and improving symptoms.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

It met the diagnostic criteria for common cold, and the severity VAS score of day or night cough was ≥40 mm ,the cough symptom score was ≥2 points;

Conforming to the standard of wind-cold cough differentiation;

Age 6-13 years old (6 years old ≤ age < 14 years old);

Duration of cough ≤48 hours;

Disqualifiers

accompanied by pharyngeal swelling pain, heat image is obvious;

White blood cell count, neutrophils absolute value, C-reactive protein, all exceeded the upper limit of 1.2 times the reference value, and the researchers considered the bacterial infection;

there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);

Patients with acute bronchitis and pneumonia cured less than 8 weeks;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Susu Xiao'er Zhike Granules

    Drug

    Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days

  • Extremely-low dose Susu Xiao'er Zhike Granules

    Drug

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

Treatment groups

360 Participants
are divided into 2 treatment groups
Group A: experimental groupExperimental treatment 1 intervention
Group B: control groupOther 1 intervention

Trial outcomes

Primary outcomes

1

Cough disappearance rate

Cough symptom scores were recorded at baseline and daily after treatment and evaluated at the end of treatment (Patients whose cough did not disappear were followed up for 24 hours).

Time frame
5 days

Secondary outcomes

1

Cough symptom score

Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.

Time frame
Baseline, 1, 2, 3, 4, and 5 days
2

VAS score of cough symptoms

Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.

Time frame
Baseline, 1, 2, 3, 4, and 5 days
3

Time to disappearance of cough

Cough symptom scores were recorded at baseline and daily after treatment and evaluated at the end of treatment (Patients whose cough did not disappear were followed up for 24 hours).

Time frame
5 days
4

Onset time of cough

Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment

Time frame
5 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

This trial is not recruiting at the moment. You can still explore other options: