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

Primary Purpose

Cold

Status
Unknown status
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Regan Tangjiang
Sponsored by
Beijing Da-an Bio-technology Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cold

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Placebo Comparator

    Arm Label

    Regan Tangjiang，Simulation Shufengjiere Capsules

    Simulation Regan Tangjiang，Shufengjiere Capsules

    Simulation Regan Tangjiang and Shufengjiere Capsules

    Arm Description

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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.
    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.
    Disappearance rate of symptoms
    The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments.
    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.
    Usage of emergency medicines
    Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).

    Full Information

    First Posted
    March 13, 2017
    Last Updated
    March 19, 2017
    Sponsor
    Beijing Da-an Bio-technology Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03089138
    Brief Title
    Efficacy and Safety of Regan Tangjiang for Treating the Common Cold With Wind-heat Syndrome
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    March 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    March 2017 (Anticipated)
    Primary Completion Date
    March 2018 (Anticipated)
    Study Completion Date
    March 2018 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Beijing Da-an Bio-technology Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cold

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantInvestigator
    Allocation
    Randomized
    Enrollment
    120 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Regan Tangjiang，Simulation Shufengjiere Capsules
    Arm Type
    Experimental
    Arm Title
    Simulation Regan Tangjiang，Shufengjiere Capsules
    Arm Type
    Active Comparator
    Arm Title
    Simulation Regan Tangjiang and Shufengjiere Capsules
    Arm Type
    Placebo Comparator
    Intervention Type
    Drug
    Intervention Name(s)
    Regan Tangjiang
    Intervention Description
    The treatment duration is 3 consecutive days.
    Primary Outcome Measure Information:
    Title
    Time to fever relief
    Description
    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.
    Time Frame
    day 1 to day 3
    Secondary Outcome Measure Information:
    Title
    Time to fever clearance
    Description
    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 Frame
    day 1 to day 3
    Title
    Time to symptom disappearance
    Description
    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.
    Time Frame
    day 1 to day 3
    Title
    Disappearance rate of symptoms
    Description
    The percentage of patients with each individual symptom completely disappear from study enrollment to three days treatments.
    Time Frame
    day 1 to day 3
    Title
    Efficacy in TCM symptom and sign scores
    Description
    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.
    Time Frame
    day 1 to day 3
    Title
    Usage of emergency medicines
    Description
    Usage of emergency medicines is defined as the percentage of patients using emergency medicines (paracetamol).
    Time Frame
    day 1 to day 3

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    No
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided

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

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