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

A Post-marketing Research on Jinyebaidu Granule in Treating Patients With Acute Upper Respiratory Infection: A Double Blind, Double Dummy, Randomized, Controlled Trial

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

Study Overview

• Status: Unknown
• Conditions: Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Jinyebaidu granule; Drug: Fufangshuanghua granule placebo; Drug: Fufangshuanghua granule; Drug: Jinyebaidu granule placebo

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

• Study Type: Interventional
• Enrollment (Anticipated): 600
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Yuan Li, bachelor; Email: zyly890609@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Recruiting
      • Guang'anmen hospital
      • Contact: Wensheng Qi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The time to defervescence	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

Outcome Measure	Measure Description	Time Frame
Change of symptoms score	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	change from baseline symptoms score at the third day and at the fifth day
Change of signs score	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	change from baseline signs score at the fifth day
Adverse events		All the time in the study
Change of routine blood test	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	Change from base line, on the fifth day
Change of urine routine	The urine routine includes white blood cell count, red blood cell count,urine protein,urine sugar	Change from base line, on the fifth day
Change of liver function	The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase	Change from base line, on the fifth day
Change of renal function	The renal function includes creatinine,usea nitrogen	Change from base line, on the fifth day
Incidence of ECG abnormalities		Change from base line, on the fifth day

Collaborators and Investigators

• Sponsor: China Academy of Chinese Medical Sciences
• Collaborators: Guangdong Provincial Hospital of Traditional Chinese Medicine; Guang'anmen Hospital of China Academy of Chinese Medical Sciences; Liaoning University of Traditional Chinese Medicine; Beijing Hospital of Traditional Chinese Medicine; First Affiliated Hospital of Heilongjiang Chinese Medicine University; Shandong University of Traditional Chinese Medicine; Changchun University of Chinese Medicine
• Investigators: Study Chair: Yanming Xie, Institute of Basic Research in Clinical Medicine, China Academy of Chinese Medical Sciences

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (ANTICIPATED): November 1, 2015
• Study Completion (ANTICIPATED): November 1, 2015

Study Registration Dates

• First Submitted: April 18, 2015
• First Submitted That Met QC Criteria: September 2, 2015
• First Posted (ESTIMATE): September 3, 2015

Study Record Updates

• Last Update Posted (ESTIMATE): September 3, 2015
• Last Update Submitted That Met QC Criteria: September 2, 2015
• Last Verified: August 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: 20141107-3.0