Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome

Beijing Da-an Bio-technology

Status and phase

Unknown

Phase 2

Conditions

Cold

Treatments

Drug: Regan Tangjiang

Study type

Interventional

Funder types

Industry

Identifiers

NCT03089138

regan tangjiang phase 2

Details and patient eligibility

About

Efficacy and Safety of Regan Tangjiang for treating the common cold with wind-heat syndrome: A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo and Active-Controlled Phase 2b Study

Enrollment

120 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Diagnosis of common cold according to Western Medicine，with symptoms onset and fever less than 24 hours prior to randomization；
After the onset of the disease, with the following symptoms: sore throat and axillary temperature between 38.5 and 38.9°C inclusive.
Diagnosis of wind-heat syndrome according to TCM；
Aged between 18 to 65 years；
Willingness to participate and to sign the informed consent form.

Exclusion criteria

Participants with Pneumonia, suppurative tonsillitis, acute tracheobronchitis, acute and chronic sinusitis, pulmonary tuberculosis and other diseases;
White blood cell count >11.0×109/L, or neutrophil percentage>75%;
Participants with liver function 1.5 times higher than the normal upper limit or serum creatinine higher than the normal upper limit;
Participants with severe primary diseases of cardiovascular, brain, lung, liver, kidney and hematopoietic system , such as viral hepatitis, hemophilia, diabetes, psychosis and so on;
Participants who had used other drugs to treat common cold after the onset of the disease, including antivirals, antibiotics and traditional Chinese medicine.
Women who are pregnant or breast-feeding;
Allergic condition (refer to history of allergy to two or more drugs or food) or allergy to the drug composition(s);
Participation in another clinical study of an investigational drug within 3 months
Participants who are not suitable for the trial decided by the researchers for any reason, such as pregnancy, frequently changes in work or living environments.