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
1 other identifier
interventional
360
1 country
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2025
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2024
CompletedFirst Posted
Study publicly available on registry
January 14, 2025
CompletedStudy Start
First participant enrolled
September 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
August 19, 2025
August 1, 2025
1.7 years
August 30, 2024
August 14, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (9)
Cough symptom score
Baseline, 1, 2, 3, 4, and 5 days
VAS score of cough symptoms
Baseline, 1, 2, 3, 4, and 5 days
Time to disappearance of cough
5 days
Onset time of cough
5 days
Disease cure rate
5 days
- +4 more secondary outcomes
Study Arms (2)
experimental group
EXPERIMENTALSusu Xiao'er Zhike Granules 1 bag
control group
OTHERExtremely-low dose Susu Xiao'er Zhike Granules 1 bag
Interventions
Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days
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
Eligibility Criteria
You may qualify if:
- 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;
- Conforming to the standard of wind-cold cough differentiation;
- Age 6-13 years old (6 years old ≤ age \< 14 years old);
- Duration of cough ≤48 hours;
- Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
- 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.
You may not qualify if:
- accompanied by pharyngeal swelling pain, heat image is obvious;
- 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;
- there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);
- Patients with acute bronchitis and pneumonia cured less than 8 weeks;
- People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
- Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
- Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
- 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;
- Allergic to known components of the investigational drug;
- Those who participated in other clinical trials and took investigational drugs within the past one month;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (19)
Anhui Provincial Children's Hospital
Hefei, Anhui, China
Jiangjin District Central Hospital of Chongqing
Chongqing, Chongqing Municipality, China
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China
Zunyi First People's Hospital
Zunyi, Guizhou, China
Xingtai People's Hospital
Xingtai, Hebei, China
The First Affiliated Hospital of Henan University
Kaifeng, Henan, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan, China
Sanmenxia Central Hospital
Sanmenxia, Henan, China
Zhengzhou First People's Hospital
Zhengzhou, Henan, China
Sinopharm Dongfeng General Hospital
Shiyan, Hubei, China
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changshang, Huna, China
Huai'an First People's Hospital
Huai'an, Jiangsu, China
Wuxi Eighth People's Hospital
Wuxi, Jiangsu, China
The Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanji, Jilin, China
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi, China
Changzhi People's Hospital
Changzhi, Shanxi, China
The Affiliated Hospital of Chengdu University of Chinese Medicine
Chengdu, Sichuan, China
The First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, 300381, China
Tianjin Children's Hospital
Tianjin, Tianjin Municipality, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Xinmin Li
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 30, 2024
First Posted
January 14, 2025
Study Start
September 1, 2025
Primary Completion (Estimated)
May 31, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
August 19, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share