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

Last updated: August 14, 2025
Sponsor: Tasly Pharmaceutical Group Co., Ltd
Overall Status: Active - Not Recruiting

Phase

3

Condition

Acute Rhinitis

Common Cold

Treatment

Extremely-low dose Susu Xiao'er Zhike Granules

High dose Susu Xiao'er Zhike Granules

Susu Xiao'er Zhike Granules

Clinical Study ID

NCT06773117
TSL-TCM-SSXEZKKL-Ⅲ
  • Ages 6-13
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  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 thelegal guardian or the subject child (≥8 years old) should sign the informed consent.

Exclusion

Exclusion Criteria:

  1. accompanied by pharyngeal swelling pain, heat image is obvious;

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

  3. there have been complications (bacterial otitis media, sinusitis, suppurativetonsillitis, 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 respiratoryinfections;

  6. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.),nasal foreign body, or foreign body inhalation, any anatomical respiratoryabnormalities;

  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 theeffectiveness 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 drugswithin the past one month;

  11. Those who were not considered suitable for inclusion by the researchers.

Study Design

Total Participants: 360
Treatment Group(s): 3
Primary Treatment: Extremely-low dose Susu Xiao'er Zhike Granules
Phase: 3
Study Start date:
September 01, 2025
Estimated Completion Date:
December 31, 2027

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, 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).

Connect with a study center

  • Anhui Provincial Children's Hospital

    Hefei, Anhui
    China

    Site Not Available

  • Jiangjin District Central Hospital of Chongqing

    Chongqing, Chongqing
    China

    Site Not Available

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangdong
    China

    Site Not Available

  • Zunyi First People's Hospital

    Zunyi, Guizhou
    China

    Site Not Available

  • Xingtai People's Hospital

    Xingtai, Hebei
    China

    Site Not Available

  • The First Affiliated Hospital of Henan University

    Kai Feng, Henan
    China

    Site Not Available

  • The First Affiliated Hospital of Nanyang Medical College

    Nanyang, Henan
    China

    Site Not Available

  • Sanmenxia Central Hospital

    Sanmenxia, Henan
    China

    Site Not Available

  • Zhengzhou First People's Hospital

    Zhengzhou, Henan
    China

    Site Not Available

  • Sinopharm Dongfeng General Hospital

    Shiyan, Hubei
    China

    Site Not Available

  • The First Affiliated Hospital of Hunan University of Chinese Medicine

    Changshang, Huna
    China

    Site Not Available

  • Huai'an First People's Hospital

    Huai'an, Jiangsu
    China

    Site Not Available

  • Wuxi Eighth People's Hospital

    Wuxi, Jiangsu
    China

    Site Not Available

  • The Affiliated Hospital of Yanbian University (Yanbian Hospital)

    Yanji, Jilin
    China

    Site Not Available

  • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

    Xianyang, Shaanxi
    China

    Site Not Available

  • Changzhi People's Hospital

    Changzhi, Shanxi
    China

    Site Not Available

  • The Affiliated Hospital of Chengdu University of Chinese Medicine

    Chengdu, Sichuan
    China

    Site Not Available

  • The First Teaching Hospital of Tianjin University of TCM

    Tianjin, Tianjin 300381
    China

    Site Not Available

  • Tianjin Children's Hospital

    Tianjin, Tianjin
    China

    Site Not Available

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