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

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.

Study Overview

• Status: Unknown
• Conditions: Cough
• Intervention / Treatment: Drug: High dose Susu Xiao'er Zhike Granules 1 bag; Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag; Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag

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 Type: Interventional
• Enrollment (Anticipated): 240
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361001
      • Recruiting
      • Xiamen Hospital of Traditional Chinese Medicine
      • Contact: Yubin Chen; Phone Number: 0592-5579686
  • Hubei
    • Wuhan, Hubei, China, 430073
      • Recruiting
      • Hubei Provincial Hospital of TCM
      • Contact: Xixiong Xiang; Phone Number: 027-88920837
  • Hunan
    • Changsha, Hunan, China, 410007
      • Recruiting
      • The First Hospital of Hunan University of Traditional Chinese Medicine
      • Contact: Mengqing Wang; Phone Number: 0371-85600717
  • Shanghai
    • Shanghai, Shanghai, China, 200071
      • Recruiting
      • Shanghai Hospital of Traditional Chinese Medicine
      • Contact: Zheng Xue; Phone Number: 021-56639828
  • Sichuan
    • Chengdu, Sichuan, China, 646000
      • Recruiting
      • Affiliated Hospital of Chengdu University of Traditional Chinese Medicine
      • Contact: Kun Yang; Phone Number: 028-87783407
  • Tianjin
    • Tianjin, Tianjin, China, 300381
      • Recruiting
      • The First Teaching Hospital of Tianjin University of TCM
      • Contact: Xinmin Li; Phone Number: 022-27986368
  • Yunnan
    • Kunming, Yunnan, China, 650021
      • Recruiting
      • Yunnan Provincial Hospital of TCM
      • Contact: Ping He; Phone Number: 0871-3632023

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 14 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: High dose group; High dose Susu Xiao'er Zhike Granules, 1 bag, bid	Drug: High dose Susu Xiao'er Zhike Granules 1 bag; 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
Experimental: Middle dose group; Middle dose Susu Xiao'er Zhike Granules, 1 bag, bid	Drug: Middle dose Susu Xiao'er Zhike Granules 1 bag; 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
Placebo Comparator: Extremely-low dose group; Extremely-low dose Susu Xiao'er Zhike Granules, 1 bag, bid	Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Tasly Pharmaceutical Group Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): September 19, 2020
• Primary Completion (Anticipated): April 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: June 23, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Actual): September 29, 2020
• Last Update Submitted That Met QC Criteria: September 27, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Susu zhike granules
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Picornaviridae Infections; Signs and Symptoms, Respiratory; Cough; Common Cold
• Other Study ID Numbers: TSL-TCM-SSXEZKKL-Ⅱ

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No