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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
Observational
Source
ITMCTR
Registry ID
ITMCTR2200005537
Enrollment
Unknown
Registered
2022-01-15
Start date
2022-02-01
Completion date
Unknown
Last updated
2023-02-20

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

test 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 Western medicine for common cold; (2) Meet the TCM standard for cold-wind-heat syndrome differentiation; (3) The duration of the cold is =48 hours; (4) Body temperature (axillary temperature) at the time of consultation: 37.3?=body temperature<39? (5) Aged 18 to 65 years old (including 18 and 65 years old), gender is not limited; (6) 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, new coronary pneumonia or contact history in an epidemic area within 14 days; (2) Combine any one of the following: herpetic angina, acute pharyngeal conjunctivitis, rhinitis, sinusitis, otitis media, suppurative tonsillitis , bronchiolitis, pulmonary tuberculosis, bronchiectasis or chest X-ray showing pulmonary inflammatory lesions and other diseases; (3) white blood cell count <3.0×109/L or exceeding the upper limit, suspected bacterial infection, or (and) neutrophils The proportion is more than 80%; (4) Complicated 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; creatinine exceeds the upper limit of normal; (5 ) pregnant, suspected pregnancy, lactating female patients or patients who refused to use contraceptive measures during the study period (including males and females); Chinese medicines or proprietary Chinese medicines with heat-clearing, detoxifying, and throat-relieving effects, or taking nourishing Chinese medicines; taking non-steroidal anti-inflammatory, antipyretic and analgesic drugs within 12 hours; (8) Suspected or actual history of alcohol or drug abuse; (9) Known resistance to experimental drugs or acetaminophen Allergic; (10) Patients who have participated in other clinical trials within three months; (11) Other conditions judged by the investigator or assistant investigator to be inappropriate 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.com18646026865

Outcome results

None listed

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