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

Launched by TASLY PHARMACEUTICAL GROUP CO., LTD · Jan 12, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the effectiveness and safety of a medicine called Susu Zhike Granules for treating coughs caused by the common cold in children aged 6 to 13 years. The goal is to see if this treatment can help reduce the cough and improve the overall symptoms quickly. It will involve children who have had a cough for less than 48 hours and score their cough severity at least 40 on a scale, which indicates a noticeable problem.

To participate, children must be in the right age group and meet certain health criteria, such as not having a high fever or other serious infections. The study is not yet recruiting participants, so if you think your child might qualify, it’s important to keep an eye out for when the trial starts. Parents or guardians will need to provide consent, and children 8 years and older will also need to agree to participate. Overall, families can expect to help test a new treatment that could benefit other children with similar cough issues in the future.

Gender

ALL

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.