A randomized, open-label, and positive drug parallel controlled study evaluating the effectiveness and safety of cold-treating granules in patients with acute onset of common cold with COPD

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2300070253

Enrollment

Unknown

Registered

2023-04-06

Start date

2021-03-07

Completion date

Unknown

Last updated

2023-06-04

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

Conditions

Chronic obstructive pulmonary disease

Interventions

Experimental group:Treat cold particles

Control group:Plate blue root granules

Eligibility

Sex/Gender

All

Age

40 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. In line with the acute exacerbation of COPD; 2. Meet the diagnostic criteria for common cold; 3. The onset of common cold is within 48 hours; 4. Body temperature < 38.5 °C; 5. Age 40 to 65 years old, gender is not limited.

Exclusion criteria

Exclusion criteria: 1. Accompanied by influenza, acute viral or herpetic pharyngitis and laryngitis, acute pharyngeal conjunctivitis, acute pharyngitis tonsillitis, acute lower respiratory tract diseases; 2. Severe rhinitis, acute and chronic sinusitis, allergic rhinitis and nasal mucosal damage; 3. Combined with serious diseases such as heart, lung, brain, liver, kidney and hematopoietic system, ALT and AST are greater than the upper limit of normal value by 2 times, and Cr is greater than the upper limit of normal value; 4. Uncontrolled hypertension and severe cardiac insufficiency; 5. Pregnant, preparing to become pregnant or breastfeeding; 6. Those who have a history of drug allergies, allergic constitutions or are known to be allergic to the constituent components of this drug; 7. Suspected or indeed have a history of alcohol or drug abuse; 8. Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months; 9. Study other patients that the doctor deems unsuitable for the subject.

Design outcomes

Primary

Measure	Time frame
Antipyretic first onset of action time (time required to start taking the drug until the body temperature drops by 0.5? and body temperature);Time to return to normal body temperature and body temperature at this time;Evaluation of the efficacy of colds;Respiratory questionnaire mMRC assessment;Self-Assessment CAT Score;Change in body temperature before and after treatment and the specific body temperature corresponding to it;Inpatient cycle assessment;Hospitalization expenses;	—

Measure

Time frame

Antipyretic first onset of action time (time required to start taking the drug until the body temperature drops by 0.5? and body temperature);Time to return to normal body temperature and body temperature at this time;Evaluation of the efficacy of colds;Respiratory questionnaire mMRC assessment;Self-Assessment CAT Score;Change in body temperature before and after treatment and the specific body temperature corresponding to it;Inpatient cycle assessment;Hospitalization expenses;

—

Secondary

Measure	Time frame
Time to pain relief;Time for nasal congestion and runny nose to subside;body temperature;pulse;Respiratory rate;Blood pressure;Pregnancy test;	—

Countries

China

Contacts

Public ContactZhang Xiaoju

Henan Provincial People's Hospital

zhangxiaoju@zzu.edu.cn+86 158 3710 1166

Outcome results

None listed

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