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Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children

Primary Purpose

Cough

Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
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
Sponsored by
Tasly Pharmaceutical Group Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cough focused on measuring Susu zhike granules

Eligibility Criteria

6 Years - 14 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Xiamen Hospital of Traditional Chinese MedicineRecruiting
  • Hubei Provincial Hospital of TCMRecruiting
  • The First Hospital of Hunan University of Traditional Chinese MedicineRecruiting
  • Shanghai Hospital of Traditional Chinese MedicineRecruiting
  • Affiliated Hospital of Chengdu University of Traditional Chinese MedicineRecruiting
  • The First Teaching Hospital of Tianjin University of TCMRecruiting
  • Yunnan Provincial Hospital of TCMRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

High dose group

Middle dose group

Extremely-low dose group

Arm Description

High dose Susu Xiao'er Zhike Granules, 1 bag, bid

Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid

Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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%.

Full Information

First Posted
June 23, 2020
Last Updated
September 27, 2020
Sponsor
Tasly Pharmaceutical Group Co., Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT04457011
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 19, 2020 (Actual)
Primary Completion Date
April 30, 2022 (Anticipated)
Study Completion Date
April 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Pharmaceutical Group Co., Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cough
Keywords
Susu zhike granules

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
240 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
High dose group
Arm Type
Experimental
Arm Description
High dose Susu Xiao'er Zhike Granules, 1 bag, bid
Arm Title
Middle dose group
Arm Type
Experimental
Arm Description
Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid
Arm Title
Extremely-low dose group
Arm Type
Placebo Comparator
Arm Description
Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid
Intervention Type
Drug
Intervention Name(s)
High dose Susu Xiao'er Zhike Granules 1 bag
Intervention Description
High dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 20.25g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Intervention Type
Drug
Intervention Name(s)
Middle dose Susu Xiao'er Zhike Granules 1 bag
Intervention Description
Middle dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 10.13g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Intervention Type
Drug
Intervention Name(s)
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag
Intervention Description
Extremely-low dose Susu Xiao'er Zhike Granules 1 bag(9g granule per bag,contains 0.51g crude herbs), twice a day (7-9a.m. and 5-7p.m.) for five days
Primary Outcome Measure Information:
Title
Time to Resolution of cough/ resolution rate
Description
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.
Secondary Outcome Measure Information:
Title
Time to relief of cough
Description
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.
Title
Area Under the cough VAS- Time Curve
Description
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
Title
Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score
Description
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
Title
Overall improvement of cough
Description
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
Title
Disappearance rate of Traditional Chinese Medicine(TCM) symptom
Description
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
Title
Curative effect of Traditional Chinese Medicine(TCM) syndrome
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rui Liu
Phone
022-86343626
Email
liurui2@tasly.com
Facility Information:
Facility Name
Xiamen Hospital of Traditional Chinese Medicine
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yubin Chen
Phone
0592-5579686
Facility Name
Hubei Provincial Hospital of TCM
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430073
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xixiong Xiang
Phone
027-88920837
Facility Name
The First Hospital of Hunan University of Traditional Chinese Medicine
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410007
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mengqing Wang
Phone
0371-85600717
Facility Name
Shanghai Hospital of Traditional Chinese Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200071
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zheng Xue
Phone
021-56639828
Facility Name
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
646000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kun Yang
Phone
028-87783407
Facility Name
The First Teaching Hospital of Tianjin University of TCM
City
Tianjin
State/Province
Tianjin
ZIP/Postal Code
300381
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xinmin Li
Phone
022-27986368
Facility Name
Yunnan Provincial Hospital of TCM
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650021
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ping He
Phone
0871-3632023

12. IPD Sharing Statement

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Efficacy and Safety of Susu Zhike Granules for Treating Acute Cough Due to Common Cold With Cold-cough Syndrome in Children

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