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

Efficacy/Safety of Susu Xiao'er Zhike Granules for Children's Cold-Induced Cough (Wind-Cold Syndrome): Multicenter, Randomized, Double-Blind, Low-Dose Controlled Phase III 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Cough
• Intervention / Treatment: Drug: Extremely-low dose Susu Xiao'er Zhike Granules; Drug: Susu Xiao'er Zhike Granules

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).

• Study Type: Interventional
• Enrollment (Estimated): 360
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Rui Liu; Phone Number: 022-86343626; Email: liurui2@tasly.com

Study Locations

• China
  • Anhui
    • Hefei, Anhui, China
      • Anhui Provincial Children's Hospital
      • Contact: Zeyu Yang; Phone Number: 13955158837
  • Chongqing
    • Chongqing, Chongqing, China
      • Jiangjin District Central Hospital of Chongqing
      • Contact: Xiaoyong Yan; Phone Number: 17783933075
  • Guangdong
    • Guangzhou, Guangdong, China
      • The First Affiliated Hospital of Guangzhou University of Chinese Medicine
      • Contact: Hua Liu; Phone Number: 13672484231
  • Guizhou
    • Zunyi, Guizhou, China
      • Zunyi First People's Hospital
      • Contact: Jianjun Su; Phone Number: 15085518551
  • Hebei
    • Xingtai, Hebei, China
      • Xingtai People's Hospital
      • Contact: Yanjun Guo; Phone Number: 13013292932
  • Henan
    • Kai Feng, Henan, China
      • The First Affiliated Hospital of Henan University
      • Contact: Hong Zhang; Phone Number: 13460773672
    • Nanyang, Henan, China
      • The First Affiliated Hospital of Nanyang Medical College
      • Contact: Yucai Chen; Phone Number: 13838783530
    • Sanmenxia, Henan, China
      • Sanmenxia Central Hospital
      • Contact: Chunying Ma; Phone Number: 15978336266
    • Zhengzhou, Henan, China
      • Zhengzhou First People's Hospital
      • Contact: Qiuping Du; Phone Number: 13526739888
  • Hubei
    • Shiyan, Hubei, China
      • Sinopharm Dongfeng General Hospital
      • Contact: Quanjing Chen; Phone Number: 13972463449
  • Huna
    • Changshang, Huna, China
      • The First Affiliated Hospital of Hunan University of Chinese Medicine
      • Contact: Jing Xie; Phone Number: 15874918189
  • Jiangsu
    • Huai'an, Jiangsu, China
      • Huai'an first people's hospital
      • Contact: Xingzhen Sun; Phone Number: 13861590017
    • Wuxi, Jiangsu, China
      • Wuxi Eighth People's Hospital
      • Contact: Rong Yu; Phone Number: 15961881280
  • Jilin
    • Yanji, Jilin, China
      • The Affiliated Hospital of Yanbian University (Yanbian Hospital)
      • Contact: Yongxue Chi; Phone Number: 15526770662
  • Shaanxi
    • Xianyang, Shaanxi, China
      • The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
      • Contact: Xiaoning Cheng; Phone Number: 13212129026
  • Shanxi
    • Changzhi, Shanxi, China
      • Changzhi People's Hospital
      • Contact: Cuiping Shen; Phone Number: 13223558677
  • Sichuan
    • Chengdu, Sichuan, China
      • The Affiliated Hospital of Chengdu University of Chinese Medicine
      • Contact: Xiangjuan Sun; Phone Number: 13678178952
  • Tianjin
    • Tianjin, Tianjin, China
      • Tianjin Children's Hospital
      • Contact: yongsheng Xu; Phone Number: 13920307707
    • Tianjin, Tianjin, China, 300381
      • The First Teaching Hospital of Tianjin University of TCM
      • Contact: Xinmin Li; Phone Number: 022-27986368

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: control group; Extremely-low dose Susu Xiao'er Zhike Granules 1 bag	Drug: Extremely-low dose Susu Xiao'er Zhike Granules; 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
Experimental: experimental group; Susu Xiao'er Zhike Granules 1 bag	Drug: Susu Xiao'er Zhike Granules; Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	5 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cough symptom score	Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.	Baseline, 1, 2, 3, 4, and 5 days
VAS score of cough symptoms	Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.	Baseline, 1, 2, 3, 4, and 5 days
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).	5 days
Onset time of cough	Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment	5 days
Disease cure rate	Cold symptoms were recorded and evaluated at baseline and after 5 days of treatment.	5 days
PAC-QoL scale score	Baseline and 5 days of treatment were recorded and evaluated.	5 days
Effective rate of TCM syndrome	Baseline and 5 days of treatment were recorded and evaluated.	5 days
The rate of disappearance of individual symptoms	Baseline and 5 days of treatment were recorded and evaluated.	5 days
Incidence OF COMPLICATIONS	Post-treatment records were recorded and end-of-treatment evaluations were performed.	5 days

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd
• Investigators: Study Chair: Xinmin Li, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Estimated): September 1, 2025
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: August 30, 2024
• First Submitted That Met QC Criteria: January 12, 2025
• First Posted (Actual): January 14, 2025

Study Record Updates

• Last Update Posted (Actual): August 19, 2025
• Last Update Submitted That Met QC Criteria: August 14, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Cough
• Other Study ID Numbers: TSL-TCM-SSXEZKKL-Ⅲ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No