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A randomized, double-blind, placebo-controlled, multi-center phase III clinical trial to evaluate the efficacy and safety of Bupleurum nasal spray in treating caused by the common cold (acute upper respiratory tract infection).

A randomized, double-blind, placebo-controlled, multi-center phase III clinical trial to evaluate the efficacy and safety of Bupleurum nasal spray in treating caused by the common cold (acute upper respiratory tract infection).

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500101527
Enrollment
Unknown
Registered
2025-04-25
Start date
2022-08-22
Completion date
Unknown
Last updated
2025-04-28

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

Conditions

Treatment of fever caused by the common cold (acute upper respiratory tract infection)

Interventions

Bupleurum nasal spray simulator:Quantitative nasal spray, 3 times a day, each side of the nasal cavity 1 spray, each spray 0.1 mi.
Bupleurum royal cavity spray:Quantitative nasal spray, 3 times a day, each side of the nasal cavity 1 spray, each spray 0.1 ml.

Sponsors

Beijing University of Chinese Medicine Dongzhimen Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria for the common cold (acute upper respiratory tract infection); (2) Body temperature (axillary temperature) >= 7.5°C and < 39°C at the time of enrollment; (3) Duration of illness <=36 hours; (4) Ages 8 to 65 years (including 18 and 65 years), gender not limited; (5) Voluntarily participate in the trial and sign informed consent form.

Exclusion criteria

Exclusion criteria: (1) Fever caused by other reasons (such as suppurative tonsillitis, acute tracheo-bronitis, pneumonia, tuberculosis, tumors, drug reactions, influenza, etc.) or fever of unknown cause; (2) Patients with severe rhinitis, acute and sinusitis, allergic rhinitis (clinical manifestations of rhinitis include nasal congestion or runny nose, nasal congestion can be alternating and intermittent or persistent, and be aggravated by work, exercise, rest or temperature changes. Runny nose is generally a thin or thick mucus, or there is a backflow of nasal m, and purulent nasal mucus often occurs with secondary infection. Some patients may have nasal itching, accompanied by paroxysmal sneezing and reduced sense of, nasal voice, etc.) and those with nasal mucosal damage; (3) Patients with a history of asthma; (4) Patients with severe malnutrition or history of convulsions, or those with hypertension (resting sitting systolic blood pressure >= 140 mmHg, diastolic blood pressure >=90 mmHg), or those with hypotension (resting sitting systolic blood pressure 10.0 × 10^9/L, or (and) neutrophil ratio > 75%; (6) Patients who have received other treatments for this disease (including antipyics, cold medications, antiviral drugs, antibiotics, traditional Chinese medicine, etc.) within 48 hours before the visit; (7) Patients with liver damage (ALT or AST >= 1.5 times the upper limit of normal), renal insufficiency (Cr > upper limit of normal); patients with severe primary of cardiovascular, cerebrovascular, endocrine and hematopoietic systems, and those with mental illness; (8) Patients with a history of alcohol or drug; (9) Pregnant or lactating women, or those who plan to have children during the study period; (10) Patients with allergic constitution or known to the investigational drug; (11) Patients who have participated in other clinical trials within the past 3 months; (12) Patients who are not to participate in this clinical trial according to the judgment of the investigator.

Design outcomes

Primary

MeasureTime frame
Complete defervescence time;

Secondary

MeasureTime frame
Time to onset of antipyretic effect ;Body temperature recovery rate;Headache symptoms;Symptoms of the common cold;Antipyretic analgesic use rate;

Countries

China

Contacts

Public ContactBan Chengjun

Beijing University of Chinese Medicine Dongzhimen Hospital

banchengjun@sina.com+86 188 0142 9198

Outcome results

None listed

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