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NCT Number: NCT04457011

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

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.

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Key information

Conditions

Cough Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Tract Diseases Signs and Symptoms Signs and Symptoms, Respiratory

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Xiamen Hospital of Traditional Chinese Medicine, Xiamen, Fujian, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. Time to relief of cough

    Time frame: The median time of relief of cough during Day 2-Day 6.

    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.

  2. Area Under the cough VAS- Time Curve

    Time frame: Baseline(Day1),Day 2-Day 6 post-treatment

    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.

  3. Parent-proxy Children's Acute Cough-specific QoL Questionnaire(PAC-QoL) scale score

    Time frame: Baseline(Day1),the last 24 hours post-treatment

    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.

  4. Overall improvement of cough

    Time frame: The last 24 hours post-treatment

    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.

  5. Disappearance rate of Traditional Chinese Medicine(TCM) symptom

    Time frame: Baseline(Day1),the last 24 hours post-treatment

    TCM syndrome includes feverish, cough,intolerance of cold, headache, body ache, nasal congestion, sneezing, runny nose, pharyngeal itching.

  6. Curative effect of Traditional Chinese Medicine(TCM) syndrome

    Time frame: Baseline(Day1),the last 24 hours post-treatment

    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%.

Sponsors and collaborators

Lead sponsor

Tasly Pharmaceutical Group Co., Ltd

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2020
Registry last updated
Sep 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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