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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
120
The treatment duration is 3 consecutive days.
Time to fever relief
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.
Time frame: day 1 to day 3
Time to fever clearance
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 frame: day 1 to day 3
Time to symptom disappearance
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.
Time frame: day 1 to day 3
Disappearance rate of symptoms
The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments.
Time frame: day 1 to day 3
Efficacy in TCM symptom and sign scores
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.
Time frame: day 1 to day 3
Usage of emergency medicines
Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).
Time frame: day 1 to day 3
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