A Phase 2 interventional study of High dose Susu Xiao'er Zhike Granules 1 bag and Middle dose Susu Xiao'er Zhike Granules 1 bag in Cough, sponsored by Tasly Pharmaceutical Group Co., Ltd. Completed at 7 sites in China. Open to participants aged 6 Years to 14 Years. Per ClinicalTrials.gov, last updated 2024-09-05.
Sponsored by Tasly Pharmaceutical Group Co., Ltd (part of China Resources Pharmaceutical Group Limited) · Phase 2, Interventional, and Treatment
This protocol is designed with the aim of exploring the efficacy of Susu on shortening duration and reducing severity of cough, and observe the safety used in children.
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, we reproduced it into a patent medicine and design this trial for evaluating it.
427 studies on the registry are indexed under Cough; 67 are open to participants now.
This study's enrollment of 240 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.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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.
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
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.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
High dose Susu Xiao'er Zhike Granules, 1 bag, bid
Drug: High dose Susu Xiao'er Zhike Granules 1 bag
Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid
Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag
Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid
Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.12 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 1.01 g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Time to Resolution of cough/ resolution rate
Clinical cure is assessed based on visual analogue scale(VAS) score of cough severity, and defined as both VAS scores of day-time and night-time cough reduce to 17mm or less, and last for 24 hours. Day-time refers to 6AM-10PM, night-time refers to 10PM-6AM. The cough VAS is a 100mm line segment, its length represents cough severity (both cough frequent and tense should be considered). 0mm=no cough, 100mm=worst cough, seriously impacting life quality such as playing, going to school, sleeping.18 Day-time and night-time VAS are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours. Children will be trained to use this assessment tool after randomized, and will recorded it by themselves via dairy with the assistance of their parents.
Time frame: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
Time to relief of cough
Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.
Time frame: The median time of relief of cough during Day 2-Day 6.
Area Under the cough VAS- Time Curve
Day-time and night-time visual analogue scale(VAS) are assessed independently on baseline (Day1) and Day 2-Day 6 to assess the severity of last 24 hours.
Time frame: Baseline(Day1),Day 2-Day 6 post-treatment
Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score
PAC-QoL is a 16-iterm parent-proxy questionnaire to reflect the frequency of particular feelings and concerns or worries of parents, developed by team of Sophie Anderson James in Australia. 7 points Lkiert-type scale (very consistent, consistent, some consistent, general, some non-consistent, non-consistent, and very inconsistent, scoring 1-7, respectively) is used to assess the quality of life of past 24 hours. Lower scores shows greater frequency, concerns, or worries, with higher scores therefore reflecting better quality of life.
Time frame: Baseline(Day1),the last 24 hours post-treatment
Overall improvement of cough
It is assessed by parents, with the question of "How is your child's cough severity changed after treatment?"(compared with 6 days ago). The response includes much better, better, no difference, worse, much worse. It will be record on Day 6.
Time frame: The last 24 hours post-treatment
Disappearance rate of Traditional Chinese Medicine(TCM) symptom
TCM syndrome includes feverish, cough,intolerance of cold, headache, body ache, nasal congestion, sneezing, runny nose, pharyngeal itching.
Time frame: Baseline(Day1),the last 24 hours post-treatment
Curative effect of Traditional Chinese Medicine(TCM) syndrome
We will assess the cure rate of symptoms respectively and the total efficacy of traditional Chinese syndrome on Day 6 via the TCM syndrome scale. Cure is defined as the score of the independent symptom decreased to 0. Efficacy means the change from baseline of total score\>50%.
Time frame: Baseline(Day1),the last 24 hours post-treatment
Ran from Sep 2020 to primary completion in Feb 2022, 17 months.
Of 21 phase 2 interventional studies under Cough, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 22. This study's 17 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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