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The safety and efficacy of Xuhanting Granular for recurrent respiratory infections in children accompanied by excessive sweating: a randomized, blinded, active-controlled and placebo-controlled, multi-center clinical trial

The safety and efficacy of Xuhanting Granular for recurrent respiratory infections in children accompanied by excessive sweating: a randomized, blinded, active-controlled and placebo-controlled, multi-center clinical trial

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-TRC-13003303
Enrollment
Unknown
Registered
2013-07-02
Start date
2013-07-15
Completion date
Unknown
Last updated
2017-04-18

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

Conditions

recurrent respiratory infections in children

Interventions

experimental group:Xuhanting Granular plus Yupingfeng Granular placebo
control group:Yupingfeng Granular plus Xuhanting Granular placebo
placebo group:Xuhanting Granular plus Yupingfeng Granular placebo

Sponsors

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 6 Years

Inclusion criteria

Inclusion criteria: 1. Children meeting the Western diagnostic criteria of recurrent respiratory infections; 2. Children of non-acute phase infection, or 1week or more after acute infection recovery; 3. Children meeting the criteria of syndrome of Qi and Yin deficiency; 4. Aged 1.5 to 6 years; 5. Disease course >=1 year; 6. Parents or guardians signed informed consent.

Exclusion criteria

Exclusion criteria: 1. Respiratory infections caused by basic disease of primary immunodeficiency disease, acquired immune deficiency syndrome (ADRS), congenital airway malformations, congenital heart disease, gastroesophageal reflux disease (GERD), and lung abnormalities etc; 2. Having used immunosuppressant or immune enhancer, as well as taken other drugs of recurrent respiratory tract infections in the past 1 year; 3. Patients with severe malnutrition, rickets as well as combined severe primary diseases of heart, brain, liver, kidney and hematopoietic systems etc; 4. Allergic patients (two or more kinds of food or drug allergies) or those who are allergic to the test drug; 5. Patients not suitable for inclusion, or influencing participation or completion of the study judged by researchers; 6. Patients participated in other clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
the amount of sweat per day (spontaneous sweating,;Compliance rate of recurrent respiratory tract infection;

Secondary

MeasureTime frame
effect of TCM syndrome;effect of sigle symptoms;effect of immune parameters (serum globulin: IgA, IgG, IgM);

Countries

China

Contacts

Public ContactSiyuan Hu
husiyuan1963@sina.com+86 022 27432275

Outcome results

None listed

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