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

NCT ID: NCT03089138

Last Updated: 2017-03-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-31
• Study Completion Date: 2018-03-31

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

Conditions

Cold

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Regan Tangjiang，Simulation Shufengjiere Capsules

Group Type: EXPERIMENTAL

Regan Tangjiang

Intervention Type: DRUG

The treatment duration is 3 consecutive days.

Simulation Regan Tangjiang，Shufengjiere Capsules

Group Type: ACTIVE_COMPARATOR

Regan Tangjiang

Intervention Type: DRUG

The treatment duration is 3 consecutive days.

Simulation Regan Tangjiang and Shufengjiere Capsules

Group Type: PLACEBO_COMPARATOR

Regan Tangjiang

Intervention Type: DRUG

The treatment duration is 3 consecutive days.

Interventions

Regan Tangjiang

The treatment duration is 3 consecutive days.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Beijing Da-an Bio-technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

regan tangjiang phase 2

Identifier Type: -

Identifier Source: org_study_id