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

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

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-Co

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

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

Current Primary Outcome: Time to fever relief [ Time Frame: day 1 to day 3 ]

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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Time to fever clearance [ Time Frame: day 1 to day 3 ]
    The median time from the first dose administration to the time when the body temperature drops below 37.3℃ and lasts for 24 hours.
  • Time to symptom disappearance [ Time Frame: day 1 to day 3 ]
    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.
  • Disappearance rate of symptoms [ Time Frame: day 1 to day 3 ]
    The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments.
  • Efficacy in TCM symptom and sign scores [ Time Frame: day 1 to day 3 ]
    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.
  • Usage of emergency medicines [ Time Frame: day 1 to day 3 ]
    Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).


Original Secondary Outcome: Same as current

Information By: Beijing Da-an Bio-technology Co., Ltd.

Dates:
Date Received: March 13, 2017
Date Started: March 2017
Date Completion: March 2018
Last Updated: March 19, 2017
Last Verified: March 2017