Randomized double-blind single-simulated multicenter confirmatory clinical trial to evaluate the efficacy and safety of Jinchai capsule in the common cold

Randomized, double-blind, single-simulated, multicenter confirmatory clinical trial to evaluate the efficacy and safety of Jinchai capsule in the common cold

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2024000901

Enrollment

Unknown

Registered

2024-12-31

Start date

2023-10-08

Completion date

Unknown

Last updated

2025-01-06

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

Conditions

common cold

Interventions

Control :Oral Jinchai capsule analog agent (placebo) 4 tablets / time

Experimental:Oral jinchai capsule 4 capsules / time

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: ? Meet the diagnostic criteria of western medicine for the common cold; ? TCM syndrome differentiation is qi Yin deficiency and wind heat; ? 4 duration of 48 hours; ? Age: 18 ~ 65 years old; ? Voluntary test and sign the informed consent form.

Exclusion criteria

Exclusion criteria: ? Body temperature> 38.5? at presentation; ? With influenza pharyngeal-conjunctivitis rhinitis sinusitis otitis media suppurative tonsillitis bronchiolitis pneumonia tuberculosis bronchiectasis or other lung diseases; ? Those who have used other cold drugs within 72 hours; ? Abnormal laboratory indicators: hemoglobin <80 g / L; platelet count <50×109 / L; total white blood cells exceeding the (excluding) upper limit of normal; neutrophils exceeding (excluding) upper limit of normal; blood creatinine exceeding (excluding) upper limit of normal; glutamate transaminase alkaline phosphatase ? -glutamanyl transtranspeptidase exceeding 1.5 times of normal (excluding); total bilirubin exceeding the upper limit of normal (excluding) 1.5 times that of that; ? Pregnant and lactating women and those with family planning in the past 3 months; ? Allergic constitution or allergic to the ingredients contained in the drugs and acetaminophen tablets used in this test; ? Participated in other clinical trials in nearly 1 month; ? The mentally ill.

Design outcomes

Primary

Measure	Time frame
Jinchai capsule and placebo compared with the treatment of the main symptom of the common cold (fever bad wind sore throat fatigue) disappearance time superiority.;	—

Secondary

Measure	Time frame
? The amount of antipyretic analgesics (acetaminophen tablets) used.;? Time to the disappearance of each minor symptom;;? The disappearance rate of each symptom;;? The change value of TCM syndrome integral;;? WURSS-21 Cold affects the ability score of clinical study participants;;? Utilization rate of antipyretic analgesics (acetaminophen tablets);;	—

Countries

China

Contacts

Public ContactMiao Qing

Xiyuan Hospital China Academy of Chinese Medical Sciences

miaoqing55@sina.com+86 13910812309

Outcome results

None listed

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