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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Cold

Intervention / Treatment
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* Drug: Regan Tangjiang


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Regan Tangjiang，Simulation Shufengjiere Capsules<br> | Drug: Regan Tangjiang<br>* The treatment duration is 3 consecutive days.<br>|
| Active Comparator: Simulation Regan Tangjiang，Shufengjiere Capsules<br> | Drug: Regan Tangjiang<br>* The treatment duration is 3 consecutive days.<br>|
| Placebo Comparator: Simulation Regan Tangjiang and Shufengjiere Capsules<br> | Drug: Regan Tangjiang<br>* The treatment duration is 3 consecutive days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | day 1 to day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | day 1 to day 3 | 
| Usage of emergency medicines | Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol). | day 1 to day 3 |