Skip to content

A randomized, double-blind, placebo-controlled, multicenter clinical trial of Jing-Fang Mixture in the treatment of acute upper respiratory tract infection(wind-cold syndrome)

A randomized, double-blind, placebo-controlled, multicenter clinical trial of Jing-Fang Mixture in the treatment of acute upper respiratory tract infection(wind-cold syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066099
Enrollment
Unknown
Registered
2022-11-24
Start date
2022-12-01
Completion date
Unknown
Last updated
2023-05-15

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

Conditions

upper respiratory tract infection

Interventions

experimental group:Jingfang Mixture
control group:Jingfang Mixture Placebo

Sponsors

China Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: ? Conform to the diagnostic criteria of "wind cold bundle exterior syndrome": 2 or more of the following symptoms have emerged: consciously afraid of cold or still feel cold after adding clothes, headache or muscle soreness, runny nose, thin white tongue coating; All the following symptoms were excluded: sweating more than usual in daily resting state (excluding sweating after taking medicine and keeping warm measures), yellow purulent mucus or viscous mucus, sore throat, cough with yellow phlegm, and dry stool; ? According to the Guidelines for Diagnosis and Treatment of Acute Upper Respiratory Tract Infection at Grassroots Level (2018), it is in line with the clinical diagnosis of "acute upper respiratory tract infection"; ? Within 48 hours of onset; ? Axillary temperature = 37.3 ?; ? Age: 18-70 (inclusive); ?Volunteer to participate in the clinical trial and sign the written informed consent;

Exclusion criteria

Exclusion criteria: ? Complicated with lower respiratory tract infection; ? The following medical histories are known: chronic respiratory diseases with respiratory failure, cardiovascular and cerebrovascular diseases (congenital heart disease, chronic heart failure, coronary artery disease or stroke; uncontrolled hypertension, excluding simple hypertension; acute stroke), advanced cancer, severe liver damage (Child Pugh C cirrhosis), uremia, diabetes ketosis, hyperthyroidism crisis, thyroid crisis Immune function inhibition (including the impairment of immune system function caused by diseases or drugs, such as subjects who use systemic steroids for a long time and subjects infected with human immunodeficiency virus (HIV)); Hepatitis C antiviral therapy is known to exist or is being received due to chronic hepatitis C virus infection. ? BMI is greater than 35 [BMI=weight (kg)/height (m) 2]; ? Women and men who are pregnant or plan to be pregnant within the next 3 months; Lactating women; During the trial or within one month after the last administration, women of childbearing age or their spouses who are unable or unwilling to take adequate contraception are unwilling to take contraceptive measures; ? Allergies to the test drug or its components; ? Within 12 hours before joining the group, we have received the treatment of traditional Chinese medicine or Chinese patent medicine containing the following contents in the functional indications of the manual: (1) the effects of relieving wind, dispelling cold, clearing heat, detoxifying, relieving exterior symptoms, relieving lung, relieving cough, promoting pharynx, detumescence, removing dampness, opening orifices, and relieving pain (2) the treatment of upper respiratory tract infection, cold, mumps, pharyngitis Traditional Chinese medicine or proprietary Chinese medicine for respiratory system diseases such as tonsillitis (such as Ganmao Qingre Granules, Lianhua Qingwen Granules, Fenghan Ganmao Granules, Jinlianhua Capsules, etc.); ? Before enrollment, they have received antiviral drugs (such as oseltamivir, amantadine, rimantadine, abidor, ribavirin, acyclovir, etc.); ? Have participated in other clinical trials or are participating in clinical trials of other drugs in recent 3 months; ? Patients considered by other investigators to be unsuitable for enrollment;

Design outcomes

Primary

MeasureTime frame
Symptom resolution time;

Secondary

MeasureTime frame
The time when the body temperature returns to normal;Time to improvement of individual symptoms;Antimicrobial use rate after enrollment;Pulmonary complication rate;All-cause hospitalization rate;Acetaminophen tablets consumption;Drug safety;

Countries

China

Contacts

Public ContactZhang Hongchun

China Japan Friendship Hospital

13701226664@163.com010-84633656

Outcome results

None listed

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