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

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 Overview

• Status: Unknown
• Conditions: Cold
• Intervention / Treatment: Drug: Regan Tangjiang

• Study Type: Interventional
• Enrollment (Anticipated): 120
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Regan Tangjiang，Simulation Shufengjiere Capsules	Drug: Regan Tangjiang; The treatment duration is 3 consecutive days.
Active Comparator: Simulation Regan Tangjiang，Shufengjiere Capsules	Drug: Regan Tangjiang; The treatment duration is 3 consecutive days.
Placebo Comparator: Simulation Regan Tangjiang and Shufengjiere Capsules	Drug: Regan Tangjiang; The treatment duration is 3 consecutive days.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Beijing Da-an Bio-technology Co., Ltd.

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2017
• Primary Completion (Anticipated): March 1, 2018
• Study Completion (Anticipated): March 1, 2018

Study Registration Dates

• First Submitted: March 13, 2017
• First Submitted That Met QC Criteria: March 19, 2017
• First Posted (Actual): March 24, 2017

Study Record Updates

• Last Update Posted (Actual): March 24, 2017
• Last Update Submitted That Met QC Criteria: March 19, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Picornaviridae Infections; Common Cold
• Other Study ID Numbers: regan tangjiang phase 2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No