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A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection

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ClinicalTrials.gov Identifier: NCT02539277
Recruitment Status : Unknown
Verified August 2015 by Junjie Jiang, China Academy of Chinese Medical Sciences.
Recruitment status was:  Recruiting
First Posted : September 3, 2015
Last Update Posted : September 3, 2015
Sponsor:
Collaborators:
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Hospital of Traditional Chinese Medicine
Changchun University of Chinese Medicine
Liaoning University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Information provided by (Responsible Party):
Junjie Jiang, China Academy of Chinese Medical Sciences

Brief Summary:

Study topic:A comparative effectiveness research on Jinyebaidu granule in treating patients with acute upper respiratory infection: A double blind, double dummy, randomized, controlled trial. It is a post-marketing clinical study to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating acute upper respiratory infection.

Objectives of Study:This study aims to evaluate effectiveness, safety and cost-effectiveness on Jinyebaidu granule in treating patients with acute upper respiratory infection.

Study design:multi-center double-blind, double-dummy, randomized, controlled trial


Condition or disease Intervention/treatment Phase
Acute Upper Respiratory Infection Drug: Jinyebaidu granule Drug: Fufangshuanghua granule Drug: Jinyebaidu granule placebo Drug: Fufangshuanghua granule placebo Phase 4

Detailed Description:
  1. Inclusion criteria

    • Patients diagnosed as acute upper respiratory infection.
    • Patients with acute upper respiratory infection diagnosed as Traditional Chinese Medicine(TCM) syndrome wind-heat attacking the Lung (type of heat pathogen invading the defensive Qi of the lung).
    • Acute upper respiratory infection onset time is less than 36 hours.
    • Patients aged 18 to 70 years old.
    • Patients agreed to participate this study and sign the informed consent.
  2. Effectiveness evaluation

    • TCM symptoms: fever, sore throat, cough with or without expectoration, headache, thirst, change of tongue body, tongue coating and pulse.
    • Signs: swollen tonsils, pharyngeal hyperemia.
    • Body temperature
  3. Safety evaluation

    • Clinical symptoms and signs of adverse event reaction
    • Signs: blood pressure, respiration, heart rate, body temperature;
    • Routine blood test and urine routine;
    • Liver function and renal function: Alanine transaminase (ALT)、glutamic-oxalacetic transaminease(AST)、serum creatinine(SCr)、urea nitrogen(BUN) ;
    • Incidence of electrocardiogram(ECG) abnormalities.
  4. Cost-effectiveness evaluation cost calculation

    • The direct medical costs include: the registration expenses, examination expenses, laboratory test expenses, Treatment costs, Chinese medicine expenses, Chinese herbal medicine expenses, western medicine expenses; Indirect medical costs: transportation costs, lost income patients; Adverse drug reactions cost: the cost of treatment due to adverse drug reactions.
    • Effect Evaluation:Symptoms and signs score, physical examination, the incidence of complications.
  5. Number of participants 600 participants will be divided into two groups, the experimental group (n=300)and the control group (n=300).Each group will be stratified into three layers according to fever, sore throat, fever and sore throats. 100 patients will be included in each level.
  6. Dose regimen

    • treatment group: Jinyebaidu granule, blunt, 10g/time, three times a day; Compound Shuanghua granules placebo, blunt, 6g /time, 4 times a day.
    • Control group: Compound double flowers particles, blunt, 6g/time, 4 times a day; Jinyebaidu Granule placebo, blunt, 10g/time, three times a day.
  7. Course of treatment:5 days

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial
Study Start Date : December 2014
Estimated Primary Completion Date : November 2015
Estimated Study Completion Date : November 2015

Arm Intervention/treatment
Experimental: Treatment group
Jinyebaidu granule, blunt, 10g / time, three times a day; Fufangshuanghua granule placebo, blunt, 6g / time, 4 times a day.
Drug: Jinyebaidu granule
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.

Drug: Fufangshuanghua granule placebo
It is Fufangshuanghua granule placebo.

Active Comparator: Control group
Fufangshuanghua granule, blunt, 6g / time, 4 times a day; Jinyebaidu granule placebo, blunt, 10g / times, three times a day.
Drug: Fufangshuanghua granule
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.

Drug: Jinyebaidu granule placebo
It is Jinyebaidu granule placebo.




Primary Outcome Measures :
  1. The time to defervescence [ Time Frame: defined as the time from the first dose of study medication to the time when the body temperature declined to lower than 37.3ºC ]

Secondary Outcome Measures :
  1. Change of symptoms score [ Time Frame: change from baseline symptoms score at the third day and at the fifth day ]

    The symptoms includes sore throat, cough, expectoration, headache, thirst. According to severity ,each symptom include four grades. The scores of sore throat are 0,2,4,6. The scores of cough, expectoration ,headache, thirst are 0,1,2,3. Compare the change from baseline all of symptoms score at the third day and at the fifth day.

    References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double——blinded observation on effect of Jinyebaidu Granule in treating the disease of wind—heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120


  2. Change of signs score [ Time Frame: change from baseline signs score at the fifth day ]

    The signs includes swollen tonsils and pharyngeal hyperemia. According to severity, each sign includes four grades. The scores are 0,4,6,8.

    References: Mao bing, Li ting-qian, Li ming-quan, Tu jin-wen, Zhang rui-ming, et al. Clinical randomized double——blinded observation on effect of Jinyebaidu Granule in treating the disease of wind—heat attacking the lung(type of heat pathogen invading the defensive Qi of the lung). chinese JounIal of Evidence-Based Medicine Jun, 2003,3(2):115-120


  3. Adverse events [ Time Frame: All the time in the study ]
  4. Change of routine blood test [ Time Frame: Change from base line, on the fifth day ]
    The routine blood test includes white blood cell count, neutral cell ratio, lymphocyte ratio, single nuclear cell ratio, red blood cell count, hemoglobin, platelet count

  5. Change of urine routine [ Time Frame: Change from base line, on the fifth day ]
    The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar

  6. Change of liver function [ Time Frame: Change from base line, on the fifth day ]
    The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase

  7. Change of renal function [ Time Frame: Change from base line, on the fifth day ]
    The renal function includes creatinine,usea nitrogen

  8. Incidence of ECG abnormalities [ Time Frame: Change from base line, on the fifth day ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria

  • Patients diagnosed as acute upper respiratory infection.
  • Patients with acute upper respiratory infection diagnosed as Traditional Chinese Medicine(TCM) syndrome wind-heat attacking the Lung (type of heat pathogen invading the defensive Qi of the lung).
  • Acute upper respiratory infection onset time is less than 36 hours.
  • Patients aged 18 to 70 years old.
  • Patients agreed to participate this study and sign the informed consent.

Exclusion Criteria:

  • Patients diagnosed with suppurative tonsillitis (third degree), and chest X-ray imaging showed lung inflammation;
  • White blood cell counts more than 12 E9, neutrophils more than 80%, ALT, AST, BUN, Cr more than 2 times of the normal upper limit;
  • Patients with temperature lower than 37.5 degree centigrade, and without sore throat;
  • Patients with temperature higher than 38.5 degree centigrade;
  • Patients already receiving antibiotics or other similar drug treatment;
  • Patients associated with other severe primary lung diseases, such as lung cancer, tuberculosis, pneumonia and other infectious diseases;
  • Patients complicated with cardiovascular and cerebrovascular diseases, severe primary diseases of hematopoietic system, mental illness;
  • Pregnant or lactating women;
  • Patients with immunodeficiency resulted from organ transplantation, HIV / AIDS, or long-term use of immunosuppressive agents;
  • Patients with drug allergy;
  • Patients participating in other clinical trials, which influence outcome evaluation of the research.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539277


Contacts
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Contact: Junjie Jiang, doctor 86-18910206360 studentjiangjunjie@163.com
Contact: Yuan Li, bachelor zyly890609@163.com

Locations
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China, Beijing
Guang'anmen Hospital Recruiting
Beijing, Beijing, China, 100053
Contact: Wensheng Qi         
Sponsors and Collaborators
China Academy of Chinese Medical Sciences
First Affiliated Hospital of Heilongjiang Chinese Medicine University
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Beijing Hospital of Traditional Chinese Medicine
Changchun University of Chinese Medicine
Liaoning University of Traditional Chinese Medicine
Shandong University of Traditional Chinese Medicine
Guangdong Provincial Hospital of Traditional Chinese Medicine
Investigators
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Study Chair: Yanming Xie Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

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Responsible Party: Junjie Jiang, assistant researcher, China Academy of Chinese Medical Sciences
ClinicalTrials.gov Identifier: NCT02539277     History of Changes
Other Study ID Numbers: 20141107-3.0
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: September 3, 2015
Last Verified: August 2015

Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases