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

Cold Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03089138
• Other study ID #: regan tangjiang phase 2
• Status: Not yet recruiting
• Phase: Phase 2
• First received: March 13, 2017
• Last updated: March 19, 2017
• Start date: March 2017
• Est. completion date: March 2018

Study information

• Verified date: March 2017
• Source: Beijing Da-an Bio-technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: March 2018
• Est. primary completion date: March 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cold
• Common Cold

Intervention

Drug:
• Regan Tangjiang
The treatment duration is 3 consecutive days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Beijing Da-an Bio-technology Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Usage of emergency medicines	Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).	day 1 to day 3