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A Randomized, Double-Blind, Multi-Center,Placebo-Parallel Controlled Trial for the Efficacy and Safety of Jingfang Granule in the Treatment of Common Cold (Wind-Cold Syndrome)

A Randomized, Double-Blind, Multi-Center,Placebo-Parallel Controlled Trial for the Efficacy and Safety of Jingfang Granule in the Treatment of Common Cold (Wind-Cold Syndrome)

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100045269
Enrollment
Unknown
Registered
2021-04-10
Start date
2021-04-13
Completion date
Unknown
Last updated
2021-11-16

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

Conditions

Common Cold

Interventions

Treatment group:Jingfang granule
Control group:Jingfang granule simulant

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1.Meet the diagnostic criteria of common cold in Western medicine; 2.Conformed to the standard of TCM syndrome differentiation of Cold(wind-cold syndrome); 3.Agef 18 ~ 70 years, gender unlimited; 4.Duration of disease <= 48 hours; 5.Signed the informed consent.

Exclusion criteria

Exclusion criteria: 1.Those who are allergic to the test drug or its components, and have allergies; 2.Combined with herpes angina, acute tonsillitis, tracheitis-bronchitis, pneumonia and other respiratory infections, or combined with bronchial asthma, influenza; 3.Abdominal pain, bloating, vomiting or diarrhea caused by other diseases such as bacillary dysentery and toxic enteritis; 4.Past history of chronic diarrhea; 5.Regular use of other drugs for the treatment of this disease within 48 hours before this visit; 6.White blood cell count 10.0 x 10^9/L, the total number of neutrophils is greater than the upper limit of normal, consider the bacterial infection; 7.ALT, AST >= 1.5 times the upper limit of normal value, Cr > upper limit of normal value; 8.Combined with serious primary diseases of the heart, liver, kidney, hematopoietic system and other important organs and systems; 9.Those who have neurological or mental illnesses who are unable to cooperate or are unwilling to cooperate; 10.There is a history of alcohol or drug abuse, or other circumstances that reduce the possibility of enrollment or complicate enrollment according to the judgment of the investigator; 11.Women during pregnancy and lactation, male and female subjects who were fertile but did not take adequate contraceptive measures during the study period; 12.Patients who have participated in other interventional clinical trials in the past 3 months.

Design outcomes

Primary

MeasureTime frame
Disease recovery time;

Secondary

MeasureTime frame
Antipyretic effect time/Complete antipyretic time;TCM Syndrome Points;Disappearance time and rate of individual symptoms;Complication rate, use of antibiotics and antipyretic analgesics;vital signs;physical examination;blood routine examination;urine routines examination;liver function;renal function;12-lead electrocardiogram;

Countries

China

Contacts

Public ContactZhang Baigang

China-Japan Friendship Hospital

zhangbogang@clkc.cn+86 13651385394

Outcome results

None listed

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