Phase III Trial of Susu Zhike Granules in Children With Cold-cough Syndrome for Acute Cough Treatment

Official title

Efficacy/Safety of Susu Xiao'er Zhike Granules for Children's Cold-Induced Cough (Wind-Cold Syndrome): Multicenter, Randomized, Double-Blind, Low-Dose Controlled Phase III Trial

Overview

To confirm the effect of Susu Xiaoer Zhike granules in treating cough caused by common cold (wind-cold cough Syndromes) in children aged 6\~13 years, shortening the course of disease and improving symptoms.

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, The investigators reproduced it into a patent medicine and design this trial for evaluating it.

The phase II clinical study of Susu Xiaoer Zhike Granules was carried out in the past, and the results showed that the use of Susu Xiaoer Zhike granules (containing 20.25g of raw drug) in the high dose group could significantly improve the clinical recovery rate (P\<0.05) and shorten the clinical recovery time (P\<0.05) in children aged 6 to 14 years (\< 14 years) caused by common cold (wind-cold cough). And good security. Based on the effectiveness and safety results of the phase II clinical study, this study intends to select the high-dose group of the phase II clinical study (containing 20.25g of raw drug) as the experimental group of the phase III clinical study, and the extremely-low dose group of the phase II clinical study as the control group. To conduct confirmatory clinical studies on cough (wind-cold cough) caused by common cold in children aged 6 to 13 years (6 years ≤ age \< 14 years).

Interventions

• Drug Susu Xiao'er Zhike Granules
  Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days
• Drug Extremely-low dose Susu Xiao'er Zhike Granules
  Extremely-low dose Susu Xiao'er Zhike Granules 1 bag (7g granule per bag,contains 1.01 g crude herbs), twice a day for five days

Primary outcome measures

• Cough disappearance rate [Time frame: 5 days]

Secondary outcome measures (9)

• Cough symptom score [Time frame: Baseline, 1, 2, 3, 4, and 5 days]
• VAS score of cough symptoms [Time frame: Baseline, 1, 2, 3, 4, and 5 days]
• Time to disappearance of cough [Time frame: 5 days]
• Onset time of cough [Time frame: 5 days]
• Disease cure rate [Time frame: 5 days]
• PAC-QoL scale score [Time frame: 5 days]
• Effective rate of TCM syndrome [Time frame: 5 days]
• The rate of disappearance of individual symptoms [Time frame: 5 days]
• Incidence OF COMPLICATIONS [Time frame: 5 days]

Eligibility criteria

Inclusion criteria

• It met the diagnostic criteria for common cold, and the severity VAS score of day or night cough was ≥40 mm ，the cough symptom score was ≥2 points;
• Conforming to the standard of wind-cold cough differentiation;
• Age 6-13 years old (6 years old ≤ age < 14 years old);
• Duration of cough ≤48 hours;
• Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;
• The informed consent process should be in accordance with the regulations, and the legal guardian or the subject child (≥8 years old) should sign the informed consent.

Exclusion criteria

• accompanied by pharyngeal swelling pain, heat image is obvious;
• White blood cell count, neutrophils absolute value, C-reactive protein, all exceeded the upper limit of 1.2 times the reference value, and the researchers considered the bacterial infection;
• there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);
• Patients with acute bronchitis and pneumonia cured less than 8 weeks;
• People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;
• Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;
• Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;
• Those who had used Chinese and Western drugs and therapies that had influence on the effectiveness evaluation of the experimental drugs within 24 h before enrollment;
• Allergic to known components of the investigational drug;
• Those who participated in other clinical trials and took investigational drugs within the past one month;
• Those who were not considered suitable for inclusion by the researchers.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

China · 19 centers

• Anhui Provincial Children's Hospital — Hefei
• Jiangjin District Central Hospital of Chongqing — Chongqing
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Guangzhou
• Zunyi First People's Hospital — Zunyi
• Xingtai People's Hospital — Xingtai
• The First Affiliated Hospital of Henan University — Kaifeng
• The First Affiliated Hospital of Nanyang Medical College — Nanyang
• Sanmenxia Central Hospital — Sanmenxia
• … and 11 more centers

Identifiers

NCT: NCT06773117 · TSL-TCM-SSXEZKKL-Ⅲ

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗