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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High dose group | Experimental | High dose Susu Xiao'er Zhike Granules, 1 bag, bid |
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| Middle dose group | Experimental | Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid |
|
| Extremely-low dose group | Placebo Comparator | Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High dose Susu Xiao'er Zhike Granules 1 bag | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | The median time of relief of cough during Day 2-Day 6. |
| Area Under the cough VAS- Time Curve |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xiamen Hospital of Traditional Chinese Medicine | Xiamen | Fujian | 361001 | China | ||
| Hubei Provincial Hospital of TCM |
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| Middle dose Susu Xiao'er Zhike Granules 1 bag | Drug | 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 | Drug | 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 |
|
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. |
| 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. | 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. | 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. | 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%. | Baseline(Day1),the last 24 hours post-treatment |
| Wuhan |
| Hubei |
| 430073 |
| China |
| The First Hospital of Hunan University of Traditional Chinese Medicine | Changsha | Hunan | 410007 | China |
| Shanghai Hospital of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | 200071 | China |
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine | Chengdu | Sichuan | 646000 | China |
| The First Teaching Hospital of Tianjin University of TCM | Tianjin | Tianjin Municipality | 300381 | China |
| Yunnan Provincial Hospital of TCM | Kunming | Yunnan | 650021 | China |
| ID | Term |
|---|---|
| D003371 | Cough |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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