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

NCT ID: NCT06773117

Last Updated: 2025-08-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 360 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-01
• Study Completion Date: 2027-12-31

Brief Summary

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).

Conditions

Cough

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

experimental group

Susu Xiao'er Zhike Granules 1 bag

Group Type: EXPERIMENTAL

Susu Xiao'er Zhike Granules

Intervention Type: DRUG

Susu Xiao'er Zhike Granules 1 bag(7g granule per bag,contains 20.25 g crude herbs), twice a day for five days

control group

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

Group Type: OTHER

Extremely-low dose Susu Xiao'er Zhike Granules

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. 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;

2. Conforming to the standard of wind-cold cough differentiation;

3. Age 6-13 years old (6 years old ≤ age < 14 years old);

4. Duration of cough ≤48 hours;

5. Maximum axillary temperature ≤38℃ within 24 hours before diagnosis;

6. 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

1. accompanied by pharyngeal swelling pain, heat image is obvious;

2. 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;

3. there have been complications (bacterial otitis media, sinusitis, suppurative tonsillitis, bronchitis, bronchopneumonia);

4. Patients with acute bronchitis and pneumonia cured less than 8 weeks;

5. People with a history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory infections;

6. Other acute episodes of nasal diseases (vasomotor rhinitis, drug rhinitis, etc.), nasal foreign body, or foreign body inhalation, any anatomical respiratory abnormalities;

7. Patients with serious systemic diseases or mental disorders such as cardiovascular, brain, liver, kidney and hematopoietic system;

8. 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;

9. Allergic to known components of the investigational drug;

10. Those who participated in other clinical trials and took investigational drugs within the past one month;

11. Those who were not considered suitable for inclusion by the researchers.

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 13 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tasly Pharmaceutical Group Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinmin Li

Role: STUDY_CHAIR

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

Locations

Anhui Provincial Children's Hospital

Hefei, Anhui, China

Jiangjin District Central Hospital of Chongqing

Chongqing, Chongqing Municipality, China

The First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Zunyi First People's Hospital

Zunyi, Guizhou, China

Xingtai People's Hospital

Xingtai, Hebei, China

The First Affiliated Hospital of Henan University

Kaifeng, Henan, China

The First Affiliated Hospital of Nanyang Medical College

Nanyang, Henan, China

Sanmenxia Central Hospital

Sanmenxia, Henan, China

Zhengzhou First People's Hospital

Zhengzhou, Henan, China

Sinopharm Dongfeng General Hospital

Shiyan, Hubei, China

The First Affiliated Hospital of Hunan University of Chinese Medicine

Changshang, Huna, China

Huai'an First People's Hospital

Huai'an, Jiangsu, China

Wuxi Eighth People's Hospital

Wuxi, Jiangsu, China

The Affiliated Hospital of Yanbian University (Yanbian Hospital)

Yanji, Jilin, China

The Second Affiliated Hospital of Shaanxi University of Chinese Medicine

Xianyang, Shaanxi, China

Changzhi People's Hospital

Changzhi, Shanxi, China

The Affiliated Hospital of Chengdu University of Chinese Medicine

Chengdu, Sichuan, China

The First Teaching Hospital of Tianjin University of TCM

Tianjin, Tianjin Municipality, China

Tianjin Children's Hospital

Tianjin, Tianjin Municipality, China

Countries

China

Central Contacts

Rui Liu

Role: CONTACT

liurui2@tasly.com

022-86343626

Facility Contacts

Zeyu Yang

Role: primary

13955158837

Xiaoyong Yan

Role: primary

17783933075

Hua Liu

Role: primary

13672484231

Jianjun Su

Role: primary

15085518551

Yanjun Guo

Role: primary

13013292932

Hong Zhang

Role: primary

13460773672

Yucai Chen

Role: primary

13838783530

Chunying Ma

Role: primary

15978336266

Qiuping Du

Role: primary

13526739888

Quanjing Chen

Role: primary

13972463449

Jing Xie

Role: primary

15874918189

Xingzhen Sun

Role: primary

13861590017

Rong Yu

Role: primary

15961881280

Yongxue Chi

Role: primary

15526770662

Xiaoning Cheng

Role: primary

13212129026

Cuiping Shen

Role: primary

13223558677

Xiangjuan Sun

Role: primary

13678178952

Xinmin Li

Role: primary

022-27986368

yongsheng Xu

Role: primary

13920307707

Other Identifiers

TSL-TCM-SSXEZKKL-Ⅲ

Identifier Type: -

Identifier Source: org_study_id