Title
Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome
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
Phase
Phase 2Lead Sponsor
Beijing Da-an Bio-technology Co., Ltd.Study Type
InterventionalStatus
Unknown statusIndication/Condition
ColdIntervention/Treatment
regan tangjiang ...Study Participants
120Efficacy 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
The treatment duration is 3 consecutive days.
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.