CoughPhase 3NCT06773117
Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment
A Phase 3 study testing Susu Xiao'er Zhike Granules and Extremely-low dose Susu Xiao'er Zhike Granules in people with Cough, run by Tasly Pharmaceutical Group Co., Ltd at 19 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 6 to 13 years
- Conditions the study is for
- Cough
- What is being tested?
- Susu Xiao'er Zhike Granules and Extremely-low dose Susu Xiao'er Zhike Granules
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 19 sitesChina
- Study dates
- 1 Sep 2025to 31 Dec 2027
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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;
- Those who were not considered suitable for inclusion by the researchers.
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
China19 sites
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changshang, Huna
Jing Xie, 15874918189
Changzhi People's Hospital
Changzhi, Shanxi
Cuiping Shen, 13223558677
The Affiliated Hospital of Chengdu University of Chinese Medicine
Chengdu, Sichuan
Xiangjuan Sun, 13678178952
Jiangjin District Central Hospital of Chongqing
Chongqing, Chongqing Municipality
Xiaoyong Yan, 17783933075
The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Hua Liu, 13672484231
Anhui Provincial Children's Hospital
Hefei, Anhui
Zeyu Yang, 13955158837
Huai'an First People's Hospital
Huai'an, Jiangsu
Xingzhen Sun, 13861590017
The First Affiliated Hospital of Henan University
Kaifeng, Henan
Hong Zhang, 13460773672
The First Affiliated Hospital of Nanyang Medical College
Nanyang, Henan
Yucai Chen, 13838783530
Sanmenxia Central Hospital
Sanmenxia, Henan
Chunying Ma, 15978336266
Sinopharm Dongfeng General Hospital
Shiyan, Hubei
Quanjing Chen, 13972463449
The First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, 300381
Xinmin Li, 022-27986368
Tianjin Children's Hospital
Tianjin, Tianjin Municipality
yongsheng Xu, 13920307707
Wuxi Eighth People's Hospital
Wuxi, Jiangsu
Rong Yu, 15961881280
The Second Affiliated Hospital of Shaanxi University of Chinese Medicine
Xianyang, Shaanxi
Xiaoning Cheng, 13212129026
Xingtai People's Hospital
Xingtai, Hebei
Yanjun Guo, 13013292932
The Affiliated Hospital of Yanbian University (Yanbian Hospital)
Yanji, Jilin
Yongxue Chi, 15526770662
Zhengzhou First People's Hospital
Zhengzhou, Henan
Qiuping Du, 13526739888
Zunyi First People's Hospital
Zunyi, Guizhou
Jianjun Su, 15085518551
About this study
Official title: 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.
Read the 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).
- Conditions
- Cough
- Being tested
- Susu Xiao'er Zhike Granules, Extremely-low dose Susu Xiao'er Zhike Granules
- Medical subject headings
- Cough
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Susu Xiao'er Zhike GranulesDrug
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 GranulesDrug
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
| Study group | Role | What they receive |
|---|---|---|
| experimental group | Experimental | Susu Xiao'er Zhike Granules 1 bag Receives: Drug: Susu Xiao'er Zhike Granules |
| control group | Other | Extremely-low dose Susu Xiao'er Zhike Granules 1 bag Receives: Drug: Extremely-low dose Susu Xiao'er Zhike Granules |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 5 days
Secondary outcomes (9)
Cough symptom score
Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.
Measured: 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.
Measured: 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).
Measured: 5 days
Onset time of cough
Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment
Measured: 5 days
Disease cure rate
Cold symptoms were recorded and evaluated at baseline and after 5 days of treatment.
Measured: 5 days
PAC-QoL scale score
Baseline and 5 days of treatment were recorded and evaluated.
Measured: 5 days
Effective rate of TCM syndrome
Baseline and 5 days of treatment were recorded and evaluated.
Measured: 5 days
The rate of disappearance of individual symptoms
Baseline and 5 days of treatment were recorded and evaluated.
Measured: 5 days
Incidence OF COMPLICATIONS
Post-treatment records were recorded and end-of-treatment evaluations were performed.
Measured: 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start1 Sep 2025 (estimated)
- Primary completion31 May 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughStudies of the same condition, open and under way.
- More trials run by Tasly Pharmaceutical Group Co., LtdThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xinmin Li, Study chair, The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06773117
- Sponsor's protocol ID
- TSL-TCM-SSXEZKKL-Ⅲ
- Status last verified
- Aug 2025
- First submitted
- 30 Aug 2024
- Last updated
- 19 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06773117
- Acronym / sponsor ID
- TSL-TCM-SSXEZKKL-Ⅲ
- Conditions
- Cough
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 31 May 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| experimental group | Experimental | Drug: Susu Xiao'er Zhike GranulesSusu Xiao'er Zhike Granules 1 bag |
| control group | Other | Drug: Extremely-low dose Susu Xiao'er Zhike GranulesExtremely-low dose Susu Xiao'er Zhike Granules 1 bag |
Who may qualify
- Ages
- 6 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (11 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Susu Xiao'er Zhike GranulesSusu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days | Drug | experimental group |
| Extremely-low dose Susu Xiao'er Zhike GranulesExtremely-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 | Drug | control group |
Primary outcome
Cough disappearance rate
Time frame: 5 days
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).
9 secondary outcomes
Cough symptom score
Time frame: Baseline, 1, 2, 3, 4, and 5 days
VAS score of cough symptoms
Time frame: Baseline, 1, 2, 3, 4, and 5 days
Time to disappearance of cough
Time frame: 5 days
Onset time of cough
Time frame: 5 days
Disease cure rate
Time frame: 5 days
PAC-QoL scale score
Time frame: 5 days
Effective rate of TCM syndrome
Time frame: 5 days
The rate of disappearance of individual symptoms
Time frame: 5 days
Incidence OF COMPLICATIONS
Time frame: 5 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xinmin Li study chair
The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Susu Xiao'er Zhike Granules and Extremely-low dose Susu Xiao'er Zhike Granules in people with Cough, run by Tasly Pharmaceutical Group Co., Ltd at 19 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rui Liu (022-86343626, liurui2@tasly.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cough disappearance rate (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2025.