Clinical trial NCT04457011: Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Cough
Keywords: Susu zhike granules
Lead sponsor: Tasly Pharmaceutical Group Co., Ltd
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 240
Sex: ALL
Minimum age (years): 6
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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;
* 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.

Primary outcomes:
measure: Time to Resolution of cough/ resolution rate
timeFrame: The median time of resolution of cough during Day 2-Day 6 and resolution rate of the last 24 hours.
Secondary outcomes:
measure: Time to relief of cough
timeFrame: The median time of relief of cough during Day 2-Day 6.
measure: Area Under the cough VAS- Time Curve
timeFrame: Baseline(Day1),Day 2-Day 6 post-treatment
measure: Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score
timeFrame: Baseline(Day1),the last 24 hours post-treatment
measure: Overall improvement of cough
timeFrame: The last 24 hours post-treatment
measure: Disappearance rate of Traditional Chinese Medicine(TCM) symptom
timeFrame: Baseline(Day1),the last 24 hours post-treatment
measure: Curative effect of Traditional Chinese Medicine(TCM) syndrome
timeFrame: Baseline(Day1),the last 24 hours post-treatment
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Xiamen Hospital of Traditional Chinese Medicine
state: Fujian
city: Wuhan
country: China
facility: Hubei Provincial Hospital of TCM
state: Hubei
city: Changsha
country: China
facility: The First Hospital of Hunan University of Traditional Chinese Medicine
state: Hunan
city: Shanghai
country: China
facility: Shanghai Hospital of Traditional Chinese Medicine
state: Shanghai
city: Chengdu
country: China
facility: Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
state: Sichuan
city: Tianjin
country: China
facility: The First Teaching Hospital of Tianjin University of TCM
state: Tianjin
city: Kunming
country: China
facility: Yunnan Provincial Hospital of TCM
state: Yunnan
Study officials:
References: