CoughPhase 2NCT04457011
Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
A Phase 2 study testing High dose Susu Xiao'er Zhike Granules 1 bag, Middle dose Susu Xiao'er Zhike Granules 1 bag and Extremely-low dose Susu Xiao'er Zhike Granules 1 bag in people with Cough, run by Tasly Pharmaceutical Group Co., Ltd at 7 sites in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 6 to 14 years
- Conditions the study is for
- Cough
- What is being tested?
- High dose Susu Xiao'er Zhike Granules 1 bag, Middle dose Susu Xiao'er Zhike Granules 1 bag and Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 240 participants
- Where
- 7 sitesChina
- Study dates
- 19 Sep 2020to 24 Feb 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosed as common cold standard, and VAS score of daytime or night-time cough >= 40mm;
- Diagnosed as wind cold cough syndrome;
- Aged 6-14 ( < 14) years;
- The course of cough is <= 48 hours;
- The maximum temperature is <= 38 degree C within 24 hours before visit;
- The informed consent process complies with the requirement,and the legal representative and the child (>= 8 years old) sign the informed consent form.
Who cannot join
- Accompanied by sore throat, obvious fever;
- The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
- With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
- Acute bronchitis, pneumonia have been cured less than 8 weeks;
- With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
- Patients with severe malnutrition;
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- Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders;
- Allergic to the experimental drugs;
- Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment;
- The investigator considers it inappropriate to participate in this clinical trial.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The First Hospital of Hunan University of Traditional Chinese Medicine
Changsha, Hunan, 410007
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
Chengdu, Sichuan, 646000
Yunnan Provincial Hospital of TCM
Kunming, Yunnan, 650021
Shanghai Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200071
The First Teaching Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality, 300381
Hubei Provincial Hospital of TCM
Wuhan, Hubei, 430073
Xiamen Hospital of Traditional Chinese Medicine
Xiamen, Fujian, 361001
About this study
Official title: The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Randomized, Double-blind, Dose Exploration,Multi-center Phase II Clinical Trial
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.
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, we reproduced it into a patent medicine and design this trial for evaluating it.
- Conditions
- Cough
- Being tested
- High dose Susu Xiao'er Zhike Granules 1 bag, Middle dose Susu Xiao'er Zhike Granules 1 bag, Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
- Keywords
- Susu 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.
High dose Susu Xiao'er Zhike Granules 1 bagDrug
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 bagDrug
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 bagDrug
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
| Study group | Role | What they receive |
|---|---|---|
| High dose group | Experimental | High dose Susu Xiao'er Zhike Granules, 1 bag, bid Receives: Drug: High dose Susu Xiao'er Zhike Granules 1 bag |
| Middle dose group | Experimental | Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid Receives: Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag |
| Extremely-low dose group | Placebo comparator | Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid Receives: Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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%.
Measured: Baseline(Day1),the last 24 hours post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2020
- Study start19 Sep 2020
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Pharmaceutical Group Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04457011
- Sponsor's protocol ID
- TSL-TCM-SSXEZKKL-Ⅱ
- Status last verified
- Aug 2024
- First submitted
- 23 Jun 2020
- Last updated
- 5 Sep 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety Evaluation of Susu Xiao'er Zhike Granules in the Treatment of the Cough Caused by the Common Cold(Wind Cold Cough Syndromes) in Children: a Randomized, Double-blind, Dose Exploration,Multi-center Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT04457011
- Acronym / sponsor ID
- TSL-TCM-SSXEZKKL-Ⅱ
- Conditions
- Cough
- Keywords
- Susu zhike granules
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Tasly Pharmaceutical Group Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 19 Sep 2020 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 7 Jul 2020 (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.
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.
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, we reproduced it into a patent medicine and design this trial for evaluating it.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| High dose group | Experimental | Drug: High dose Susu Xiao'er Zhike Granules 1 bagHigh dose Susu Xiao'er Zhike Granules, 1 bag, bid |
| Middle dose group | Experimental | Drug: Middle dose Susu Xiao'er Zhike Granules 1 bagMiddle dose Susu Xiao'er Zhike Granules, 1 bag, bid |
| Extremely-low dose group | Placebo comparator | Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bagExtremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Diagnosed as common cold standard, and VAS score of daytime or night-time cough >= 40mm;
- Diagnosed as wind cold cough syndrome;
- Aged 6-14 ( < 14) years;
- The course of cough is <= 48 hours;
- The maximum temperature is <= 38 degree C within 24 hours before visit;
Key exclusion criteria (10 listed)
- Accompanied by sore throat, obvious fever;
- The white blood cell count(WBC), absolute value of neutrophils(NEU) and c-reactive protein(CRP) all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection;
- With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia;
- Acute bronchitis, pneumonia have been cured less than 8 weeks;
- With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection;
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 |
|---|---|---|
| High dose Susu Xiao'er Zhike Granules 1 bagHigh 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 | Drug | High dose group |
| Middle dose Susu Xiao'er Zhike Granules 1 bagMiddle 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 | Drug | Middle dose group |
| Extremely-low dose Susu Xiao'er Zhike Granules 1 bagExtremely-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 | Drug | Extremely-low dose group |
Primary outcome
Time to Resolution of cough/ resolution rate
Time frame: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
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.
6 secondary outcomes
Time to relief of cough
Time frame: The median time of relief of cough during Day 2-Day 6.
Area Under the cough VAS- Time Curve
Time frame: Baseline(Day1),Day 2-Day 6 post-treatment
Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score
Time frame: Baseline(Day1),the last 24 hours post-treatment
Overall improvement of cough
Time frame: The last 24 hours post-treatment
Disappearance rate of Traditional Chinese Medicine(TCM) symptom
Time frame: Baseline(Day1),the last 24 hours post-treatment
Curative effect of Traditional Chinese Medicine(TCM) syndrome
Time frame: Baseline(Day1),the last 24 hours post-treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2024.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing High dose Susu Xiao'er Zhike Granules 1 bag, Middle dose Susu Xiao'er Zhike Granules 1 bag and Extremely-low dose Susu Xiao'er Zhike Granules 1 bag in people with Cough, run by Tasly Pharmaceutical Group Co., Ltd at 7 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 10 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: finished, as of the sponsor's last update on 5 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Resolution of cough/ resolution rate (time frame: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.). 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 5 Sep 2024.