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Phase IIa study for Kemin capsule in the treatment of post infectious cough: a randomized controlled trial

Phase IIa study for Kemin capsule in the treatment of post infectious cough: a randomized controlled trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900026505
Enrollment
Unknown
Registered
2019-10-12
Start date
2019-10-11
Completion date
Unknown
Last updated
2019-10-14

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

Conditions

Post infectious cough (wind-cold lung syndrome)

Interventions

High dose group:Kemin capsule 5 pills/time, 3 times/day, oral.
Middle dose group :Kemin capsule 3 pills + simulant 2 pills/time, 3 times/day, oral.
Low dose group:Kemin capsule 1 pill + simulant 4 pills/time, 3 times/day, oral administration.

Sponsors

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic criteria for Post infectious cough; 2. It conforms to the standard of TCM diagnosis and syndrome differentiation of cough-wind-cold lung syndrome; 3. VAS score of cough >=60 (0-100mm scale); 4. Duration of cough is 3-6 weeks; 5. Aged 18 to 65 years; 6. The informed consent process conforms to the ethical requirements, and subjects or legal representatives sign informed consent.

Exclusion criteria

Exclusion criteria: 1. Meet the screening criteria for common causes of chronic cough (CVA, UACS, EB, GERC). 2. Meet the screening criteria for pertussis. 3. History of cough-related chronic lung disease (including but not limited to bronchiectasis, chronic bronchitis, bronchial asthma, COPD, bronchial lung cancer, trachea-bronchial/tuberculosis). 4. Taking ACEI preparation. 5. Smoke, or quit for less than 6 months. 6. Combined with known immunocompromised or immunocompromised diseases. 7. It conforms to the standard of TCM diagnosis and syndrome differentiation of Yin deficiency/damp-heat constitution. 8. Body temperature (underarm) =37.3?. 9. Complicated with serious cardiovascular, respiratory, digestive, urinary, hematopoietic and metabolic diseases. 10. The upper limit of normal values of ALT and AST > is 1.5 times, and the upper limit of normal values of Cr >. 11. Suspect or have a history of alcohol or drug abuse. 12. Persons who are legally disabled (blind, deaf, mute, mentally retarded, mentally retarded, etc.). 13. Known or suspected allergies to the tested drug ingredients. 14.Women who are pregnant or preparing to become pregnant or lactating. 15. Participated in clinical trials of other drugs within the past 3 months. 16. The investigator considers it inappropriate to participate in this clinical trial.

Design outcomes

Primary

MeasureTime frame
Cough disappearance time;Incidence of clinical adverse events/reactions;

Secondary

MeasureTime frame
Cough disappearance rate;Cough VAS score AUC;Changes in cough questionnaire (LCQ) scores;Cough symptom (daytime, night) integral change;Curative effect of TCM syndrome;Vital signs;Blood routine, urine routine, electrocardiogram, liver and kidney function, urine enzyme;

Countries

China

Contacts

Public ContactLiu Min

The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine

liumintcm@163.com+86 13132296378

Outcome results

None listed

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