The efficacy and safety evaluation of Xiao'er Kechuan Granule in children’s Cough Variant Asthma with syndrome of wind invading lung: a randomized, double-blind, double-dummy, parallel, active-controlled, Dose exploration,multi-center clinical trial

The efficacy and safety evaluation of Xiao'er Kechuan Granule in treating Children’s Cough Variant Asthma with syndrome of wind invading lung: a randomized, double-blind, double-dummy, parallel, active-controlled, Dose exploration,multi-center clinical trial

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR-IPR-15006578

Enrollment

Unknown

Registered

2015-06-15

Start date

2015-06-22

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

Cough Variant Asthma

Interventions

A:Take Xiao'er Kechuan Granule 2 bags,Tid

montelukast (Singulair) placebo,1 pill ,Qn p.o

B:Take Xiao'er Kechuan Granule 1 bag and Xiao'er Kechuan Granule placebo 1 bag,Tid

C:Take Xiao'er Kechuan Granule placebo 2 bags,Tid

D:Take Xiao'er Kechuan Granule 2 bags,Tid

montelukast (Singulair),1 pill ,Qn p.o

Eligibility

Sex/Gender

All

Age

4 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. Children in Cough Variant Asthma; 2. Children with TCM syndrome of wind invading lung; 3. Ages 4 to 7 years (<8 years), males or females; 4. Guardian submitted informed consent.

Exclusion criteria

Exclusion criteria: 1. Gastroesophageal Reflux Cough, Psychogenic cough, Drug-induced cough, Otogenic cough, Congenital Respiratory Disorders, foreign bodya spiration,respiratory infections caused by specific pathogen, Protracted Bacterial Bronchitis, upper airway cough syndrome, etc.; 2. Have used Asthma Control Dosing within 2 weeks, just like ICS, leukotriene modifier, Long- Effect beta 2 Reactant Excitomotor Agent, sustained-release theophylline, and systemic corticosteroid; Have used Antihistamine, anti-allergic agent, rapidly available beta-adrenergic receptor agonists, theophylline, etc. 3. Allergic constitution or allergic to drug used in this study; 4. Combined with Severe systemic disease such as cardiocerebral vascular system, endocrine system, Hematologic System, liver or kidney disease, etc. 5. Those who are inclined to lose follow-up based on the investigator's judgment.

Design outcomes

Primary

Measure	Time frame
average score of cough severity (day & night);	—

Secondary

Measure	Time frame
assessment of disease control;limited activity and noctural symptom and situation of rescue medication/emergency requirement;PEF mutation rate per day;Efficacy of TCM syndrome;	—

Countries

China

Contacts

Public ContactSiyuan Hu

husiyuan1963@sina.com+86 022 27986262

Outcome results

None listed

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