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

Официальное название

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

Обзор

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.

Подробное описание

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).

Вмешательства

• Препарат 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
• Препарат 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

Первичные конечные точки

• Cough disappearance rate [Срок оценки: 5 days]

Вторичные конечные точки (9)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 19 центров

• Anhui Provincial Children's Hospital — Хэфэй
• Jiangjin District Central Hospital of Chongqing — Чунцин
• The First Affiliated Hospital of Guangzhou University of Chinese Medicine — Гуанчжоу
• 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
• … и ещё 11 центров

Идентификаторы

NCT: NCT06773117 · TSL-TCM-SSXEZKKL-Ⅲ

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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