A Phase 3 interventional study of Susu Xiao'er Zhike Granules and Extremely-low dose Susu Xiao'er Zhike Granules in Cough, sponsored by Tasly Pharmaceutical Group Co., Ltd. Not yet recruiting at 19 sites in China. Open to participants aged 6 Years to 13 Years. Per ClinicalTrials.gov, last updated 2025-08-19.
Sponsored by Tasly Pharmaceutical Group Co., Ltd (part of China Resources Pharmaceutical Group Limited) · Phase 3, Interventional, and Treatment
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.
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).
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's planned enrollment of 360 is above the median of 80 across 319 interventional studies indexed under Cough.
Browse Cough studies →Tasly Pharmaceutical Group Co., Ltd is the lead sponsor of 32 studies on the registry; 17 are open to participants now.
First submitted before Tasly Pharmaceutical Group Co., Ltd became part of China Resources Pharmaceutical Group Limited.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Susu Xiao'er Zhike Granules 1 bag
Drug: Susu Xiao'er Zhike Granules
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
Drug: Extremely-low dose 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
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
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).
Time frame: 5 days
Cough symptom score
Baseline and post-treatment were recorded daily, and diachronic changes were evaluated at the end of treatment.
Time frame: 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.
Time frame: 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).
Time frame: 5 days
Onset time of cough
Cough VAS score were recorded at baseline and daily after treatment and evaluated at the end of treatment
Time frame: 5 days
Disease cure rate
Cold symptoms were recorded and evaluated at baseline and after 5 days of treatment.
Time frame: 5 days
PAC-QoL scale score
Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
Effective rate of TCM syndrome
Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
The rate of disappearance of individual symptoms
Baseline and 5 days of treatment were recorded and evaluated.
Time frame: 5 days
Incidence OF COMPLICATIONS
Post-treatment records were recorded and end-of-treatment evaluations were performed.
Time frame: 5 days
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2025; primary completion for May 2027, 20 months later.
Of 18 phase 3 interventional studies under Cough, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 37. This study's planned 20 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
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Tasly Pharmaceutical Group Co., Ltd →