Cold
Conditions
Brief summary
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
Interventions
DRUGRegan Tangjiang
The treatment duration is 3 consecutive days.
Sponsors
Beijing Da-an Bio-technology Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to fever relief | day 1 to day 3 | The median time from the first dosing to time when the body temperature drops by at least 0.5℃.In this study, all patients will be required to record their body temperature in the patient diary every 2 hours within the first 12 hours and every 4 hours during the following 12 hours. After that, it should be recorded four times at a fixed time every day. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to fever clearance | day 1 to day 3 | The median time from the first dose administration to the time when the body temperature drops below 37.3℃ and lasts for 24 hours. |
| Time to symptom disappearance | day 1 to day 3 | The median time from study enrollment to the time when each individual symptom （such as fever, pharyngalgia, headache, runny nose, blocked nose, sneezing, cough） completely disappear. |
| Disappearance rate of symptoms | day 1 to day 3 | The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments. |
| Efficacy in TCM symptom and sign scores | day 1 to day 3 | The TCM symptom scoring system used in the study follows the Guidelines for Clinical Research of New Chinese Medicine, in which all symptoms are graded. |
| Usage of emergency medicines | day 1 to day 3 | Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol). |
Outcome results
None listed