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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-b

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-b

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR1900002853
Enrollment
Unknown
Registered
2019-12-20
Start date
2020-01-01
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough

Interventions

Middle dose group:Middle dose Susu Xiao'er Zhike Granules 1 bag, B.i.d.
High dose group:High dose Susu Xiao'er Zhike Granules 1 bag, B.i.d.
Extremely-low dose group:Extremely-low dose Susu Xiao'er Zhike Granules 1 bag, B.i.d.

Sponsors

The First Teaching Hospital of Tianjin University of TCM
Lead Sponsor

Eligibility

Sex/Gender
All
Age
6 Years to 13 Years

Inclusion criteria

Inclusion criteria: 1. Diagnosed as common cold standard, and VAS score of daytime or night-time cough >= 40mm; 2. Diagnosed as wind cold cough syndrome; 3. Aged 6-14 ( = 8 years old) sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Accompanied by sore throat, obvious fever; 2. The WBC, NEU and CRP all exceeded 1.2 times of the upper limit of the reference value, and the researchers considered bacterial infection; 3. With complication, such as otitis media, sinusitis, acute bronchitis, pneumonia; 4. Acute bronchitis, pneumonia have been cured less than 8 weeks; 5. With a medical history of seasonal or perennial allergic rhinitis, chronic sinusitis, chronic otitis media, bronchial asthma, chronic cough or recurrent respiratory tract infection; 6. Patients with severe malnutrition; 7. Patients with other serious systemic diseases of the cardiovascular, brain, liver, kidney and hematopoietic systems, any anatomical or respiratory abnormalities or mental disorders; 8. Allergic to the experimental drugs; 9. Received antihistamines or any cough medicine, oral or inhaled steroid preparation before enrollment; 10. The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Time to Resolution of cough/ resolution rate;

Secondary

MeasureTime frame
Disappearance rate of TCM symptom ;Overall improvement of cough;Curative effect of TCM syndrome;Area Under the cough VAS- Time Curve;Time to relief of cough;PAC-QoL scale score;

Countries

China

Contacts

Public ContactXinmin Li
tjtcmlxm@163.com+86 022-27986368

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026