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

Last updated: August 30, 2024
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Completed

Phase

2

Condition

Common Cold

Acute Rhinitis

Treatment

Middle dose Susu Xiao'er Zhike Granules 1 bag

High dose Susu Xiao'er Zhike Granules 1 bag

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

Clinical Study ID

NCT04457011
TSL-TCM-SSXEZKKL-Ⅱ
  • Ages 6-14
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 legalrepresentative and the child (>= 8 years old) sign the informed consent form.

Exclusion

Exclusion Criteria:

  • Accompanied by sore throat, obvious fever;

  • The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactiveprotein(CRP) all exceeded 1.2 times of the upper limit of the reference value, andthe 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, chronicsinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrentrespiratory 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 ormental disorders;

  • Allergic to the experimental drugs;

  • Received antihistamines or any cough medicine, oral or inhaled steroid preparationbefore enrollment;

  • The investigator considers it inappropriate to participate in this clinical trial.

Study Design

Total Participants: 240
Treatment Group(s): 3
Primary Treatment: Middle dose Susu Xiao'er Zhike Granules 1 bag
Phase: 2
Study Start date:
September 19, 2020
Estimated Completion Date:
February 24, 2022

Study 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.

Connect with a study center

  • Xiamen Hospital of Traditional Chinese Medicine

    Xiamen, Fujian 361001
    China

    Site Not Available

  • Hubei Provincial Hospital of TCM

    Wuhan, Hubei 430073
    China

    Site Not Available

  • The First Hospital of Hunan University of Traditional Chinese Medicine

    Changsha, Hunan 410007
    China

    Site Not Available

  • Shanghai Hospital of Traditional Chinese Medicine

    Shanghai, Shanghai 200071
    China

    Site Not Available

  • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

    Chengdu, Sichuan 646000
    China

    Site Not Available

  • The First Teaching Hospital of Tianjin University of TCM

    Tianjin, Tianjin 300381
    China

    Site Not Available

  • Yunnan Provincial Hospital of TCM

    Kunming, Yunnan 650021
    China

    Site Not Available

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