Clinical trial NCT06773117: Phase III Clinical Study on Efficacy y and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
Official title: The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Multicenter, Randomized, Double-blind, Low-dose Controlled Phase III Clinical Tria
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Cough
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 360
Sex: ALL
Minimum age (years): 6
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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, The investigators reproduced it into a patent medicine and design this trial for evaluating it.

The phase II clinical study of Susu Xiaoer Zhike Granules was carried out in the past, and the results showed that the use of Susu Xiaoer Zhike granules (containing 20.25g of raw drug) in the high dose group could significantly improve the clinical recovery rate (P\<0.05) and shorten the clinical recovery time (P\<0.05) in children aged 6 to 14 years (\< 14 years) caused by common cold (wind-cold cough). And good security. Based on the effectiveness and safety results of the phase II clinical study, this study intends to select the high-dose group of the phase II clinical study (containing 20.25g of raw drug) as the experimental group of the phase III clinical study, and the extremely-low dose group of the phase II clinical study as the control group. To conduct confirmatory clinical studies on cough (wind-cold cough) caused by common cold in children aged 6 to 13 years (6 years ≤ age \< 14 years).

Eligibility criteria: Inclusion Criteria:

1. It met the diagnostic criteria for common cold, and the severity VAS score of day or night cough was ≥40 mm;
2. Conforming to the standard of wind-cold cough differentiation;
3. Age 6-13 years old (6 years old ≤ age \< 14 years old);
4. Duration of cough ≤48 hours;
5. Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
6. The informed consent process should be in accordance with the regulations, and the legal guardian or the subject child (≥8 years old) should sign the informed consent.

Exclusion Criteria:

1. accompanied by pharyngeal swelling pain, heat image is obvious;
2. 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;
3. there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);
4. Patients with acute bronchitis and pneumonia cured less than 8 weeks;
5. People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
6. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
7. Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
8. Those who had used Chinese and Western drugs and therapies that had influence on the effectiveness evaluation of the experimental drugs within 24 h before enrollment;
9. Allergic to known components of the investigational drug;
10. Those who participated in other clinical trials and took investigational drugs within the past one month;
11. Those who were not considered suitable for inclusion by the researchers.

Primary outcomes:
measure: Cough disappearance rate
timeFrame: 5 days
Secondary outcomes:
measure: Cough symptom score
timeFrame: Baseline, 1, 2, 3, 4, and 5 days
measure: VAS score of cough symptoms
timeFrame: Baseline, 1, 2, 3, 4, and 5 days
measure: Time to disappearance of cough
timeFrame: 5 days
measure: Onset time of cough
timeFrame: 5 days
measure: Disease cure rate
timeFrame: 5 days
measure: PAC-QoL scale score
timeFrame: 5 days
measure: Effective rate of TCM syndrome
timeFrame: 5 days
measure: The rate of disappearance of individual symptoms
timeFrame: 5 days
measure: Incidence OF COMPLICATIONS
timeFrame: Up to 8 days
Other outcomes:
Locations:
city: Tianjin
country: China
facility: The First Teaching Hospital of Tianjin University of TCM
state: Tianjin
Study officials:
References: