Title

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
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Unknown status
  • Indication/Condition

    Cold
  • Study Participants

    120
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 Started
Mar 31
2017
Anticipated
Primary Completion
Mar 31
2018
Anticipated
Study Completion
Mar 31
2018
Anticipated
Last Update
Mar 24
2017

Drug Regan Tangjiang

The treatment duration is 3 consecutive days.

Regan Tangjiang,Simulation Shufengjiere Capsules Experimental

Simulation Regan Tangjiang,Shufengjiere Capsules Active Comparator

Simulation Regan Tangjiang and Shufengjiere Capsules Placebo Comparator

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.
No Results Posted