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A randomized, double-blind, parallel-controlled, multi-center clinical trial of Chinese medicine variety protection with Niuhuang Qinggan Capsule in the treatment of common cold (wind-heat syndrome)

A randomized, double-blind, parallel-controlled, multi-center clinical trial of Chinese medicine variety protection with Niuhuang Qinggan Capsule in the treatment of common cold (wind-heat syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200055642
Enrollment
Unknown
Registered
2022-01-15
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-13

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

Conditions

Common cold (wind-heat syndrome)

Interventions

Experimental group:Niuhuang Qinggan Capsule

Sponsors

The Second Affiliated Hospital of Heilongjiang 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 of the common cold in western medicine; 2. Conform to the TCM syndrome differentiation standard of cold-wind-heat syndrome; 3. Cold duration <= 48 hours; 4. Body temperature (armpit temperature) at the time of consultation: 37.3 degree C <= body temperature < 39 degree C; 5. Aged 18-65 years (including 18 and 65 years old), gender is not limited; 6. The subjects gave informed consent, volunteered to be tested and signed the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Have a confirmed case of influenza or new coronary pneumonia or a history of contact with an epidemic area within 14 days; 2. Combining any one of: herpetic angina, acute pharyngoconjunctivitis, rhinitis, sinusitis, otitis media, suppurative tonsillitis, bronchiolitis, tuberculosis, bronchiectasis, or chest X-ray showing pulmonary inflammatory lesions and other diseases; 3. The white blood cell count is 80%; 4. Combined with serious primary diseases of the heart, brain, lung, liver, kidney, and hematopoietic system; abnormal liver and kidney function ALT, AST >= 1.5 times the upper limit of normal value; creatinine exceeding the upper limit of normal value; 5. Pregnancy, suspicious pregnancy, breastfeeding female patients or patients who refuse to use contraception during the study (including male and female); 6. Accept antibacterial, antiviral traditional Chinese medicine or western medicine treatment during this course of disease, or take traditional Chinese medicine or Chinese patent medicine with the effects of dispelling wind, clearing heat, detoxifying, and relieving throat, or taking nourishing Chinese medicine; taking non-steroidal anti-inflammatory drugs within 12 hours antipyretic analgesics; 7. Those who cannot cooperate with physical or mental diseases (such as blindness, deafness, dumbness, mental retardation, mental disorder, etc.), or those with serious diseases that affect survival (such as tumors, etc.); 8. Suspect or have a history of alcohol and drug abuse; 9. Those who are known to be allergic to the test drug or acetaminophen; 10. Patients who have participated in other clinical trials within three months; 11. Other situations where the researcher or assistant researcher judges that he is not suitable to participate in the study.

Design outcomes

Primary

MeasureTime frame
Temperature return time;

Secondary

MeasureTime frame
Body temperature normalization rate;Therapeutic effects of TCM syndromes;Therapeutic effect of TCM single symptom;

Countries

China

Contacts

Public ContactShanjun Yang

The Second Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine

ysj119@126.com+86 18646026865

Outcome results

None listed

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