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Phase II clinical trial for ''xiaoer Ma-Long-Zhi-Ke-Ping-Chuan Granule'' in the children's cough variant asthma

Randomized, double-blind, dose-based, placebo-controlled, multi-center Phase II clinical trial for the efficacy and safety of ''xiaoer Ma-Long-Zhi-Ke-Ping-Chuan Granule'' in the treatment of children with cough variant asthma (Tan-Re Yun-Fei syndrome)

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000032744
Enrollment
Unknown
Registered
2020-05-09
Start date
2019-11-01
Completion date
Unknown
Last updated
2020-05-11

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

Conditions

children's cough variant asthma

Interventions

High-dose group:''xiaoer Ma-Long-Zhi-Ke-Ping-Chuan Granules''
Low Dose Group:''xiaoer Ma-Long-Zhi-Ke-Ping-Chuan Granules'' + simulate
Placebo Group:''xiaoer Ma-Long-Zhi-Ke-Ping-Chuan Granules'' simulate

Sponsors

Shanghai Municipal Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 7 Years

Inclusion criteria

Inclusion criteria: 1. According with the Western diagnostic criteria of cough variant asthma in children; 2. Standard of syndrome differentiation of traditional Chinese medicine in accordance with phlegm-heat retention of Lung Syndrome; 3. Cough severity (day and night) score >=4; 4. Between the ages of 4 and 7 years; 5. The process of informed consent is in compliance with the relevant provisions, and the legal guardian signs the informed consent.

Exclusion criteria

Exclusion criteria: 1. Chronic cough caused by acid reflux disease cough, psychogenic cough, drug induced cough, otogenic cough, congenital respiratory disease, foreign body inhalation, respiratory tract infection caused by specific pathogens, persistent bacterial bronchitis, etc. , and patients with Upper Airway Cough Syndrome alone; 2. During 2 weeks prior to selection, asthma control treatments such as inhalation of Glucocorticoid, leukotriene modulators, long acting 2 receptor agonists, slow release theophylline, and systemic glucocorticoid were used; Those who had taken antihistamines, antiallergic drugs, systemic fast-acting 2-receptor agonists, theophylline within 1 week before being selected, as well as traditional Chinese medicines (including decoction, decoction pieces, prescription granules and proprietary Chinese medicines) with antitussive, expectorant and antiasthmatic effects; 3. Patients with severe malnutrition, Rachitis and complicated primary diseases of heart, brain, liver, kidney and Hematopoiesis, especially those with AST, ALT, SCR > the upper limit of normal value; 4. Persons Allergic to experimental drugs and their components; 5. Patients in other clinical trials within 1 month; 6. The researchers did not consider it appropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Cough severity (day and night) score;Onset time and efficiency of cough;Duration and rate of cough relief;

Secondary

MeasureTime frame
Reduction in number and usage of pharmaceutical products;TCM syndrome integral;Single symptom of traditional Chinese Medicine;

Countries

China

Contacts

Public ContactXue Zheng

Shanghai Municipal Hospital of Traditional Chinese Medicine

shszyyyek@126.com+86 18621905133

Outcome results

None listed

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