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

NCT04457011 | Completed Phase 2

• 1 other identifier: TSL-TCM-SSXEZKKL-Ⅱ
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 7

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.

Conditions

Cough

Keywords

Susu zhike granules

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Time to relief of cough

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

• Area Under the cough VAS- Time Curve

  Baseline(Day1),Day 2-Day 6 post-treatment

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

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

• Overall improvement of cough

  The last 24 hours post-treatment

• Disappearance rate of Traditional Chinese Medicine(TCM) symptom

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

Study Arms (3)

High dose group

EXPERIMENTAL

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

Drug: High dose Susu Xiao'er Zhike Granules 1 bag

Middle dose group

EXPERIMENTAL

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

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

Drug: Extremely-low dose Susu Xiao'er Zhike Granules 1 bag

Interventions

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

High dose group

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

Middle dose group

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

Extremely-low dose group

Eligibility Criteria

• Age: 6 Years - 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tasly Pharmaceutical Group Co., Ltd: lead

Study Sites (7)

Xiamen Hospital of Traditional Chinese Medicine

Xiamen, Fujian, 361001, China

Location

Hubei Provincial Hospital of TCM

Wuhan, Hubei, 430073, China

Location

The First Hospital of Hunan University of Traditional Chinese Medicine

Changsha, Hunan, 410007, China

Location

Shanghai Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, 200071, China

Location

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine

Chengdu, Sichuan, 646000, China

Location

The First Teaching Hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, 300381, China

Location

Yunnan Provincial Hospital of TCM

Kunming, Yunnan, 650021, China

Location

MeSH Terms

Conditions

Cough

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2020
• First Posted: July 7, 2020
• Study Start: September 19, 2020
• Primary Completion: February 24, 2022
• Study Completion: February 24, 2022
• Last Updated: September 5, 2024

Record last verified: 2024-08

Locations

CN (7)