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

Acute Upper Respiratory Infection Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02539277
• Other study ID #: 20141107-3.0
• Status: Recruiting
• Phase: Phase 4
• First received: April 18, 2015
• Last updated: September 2, 2015
• Start date: December 2014
• Est. completion date: November 2015

Study information

• Verified date: August 2015
• Source: China Academy of Chinese Medical Sciences
• Contact: Junjie Jiang, doctor
• Phone: 86-18910206360
• Email: studentjiangjunjie[@]163.com
• Is FDA regulated: No
• Health authority: China: State Administration of Traditional Chinese Medicine
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Infection
• Respiratory Tract Infections

Intervention

Drug:
• Jinyebaidu granule
It is a chinese patent medicine extracted from four herbs: honeysuckle, isatis leaf, dandelion, and houttuynia cordata thunb.
• Fufangshuanghua granule
It is a Chinese patent medicne extracted from four herbs: honeysuckle, forsythia, radix Isatidis, andrographis paniculata.
• Jinyebaidu granule placebo
It is Jinyebaidu granule placebo.
• Fufangshuanghua granule placebo
It is Fufangshuanghua granule placebo.

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (8)

Lead Sponsor	Collaborator
China Academy of Chinese Medical Sciences	Beijing Hospital of Traditional Chinese Medicine, Changchun University of Chinese Medicine, First Affiliated Hospital of Heilongjiang Chinese Medicine University, Guang'anmen Hospital of China Academy of Chinese Medical Sciences, Guangdong Provincial Hospital of Traditional Chinese Medicine, Liaoning University of Traditional Chinese Medicine, Shandong University of Traditional Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Adverse events		All the time in the study	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	Change of liver function	The liver function includes glutamic-pyruvic transaminase,glutamic-oxalacetic transaminase	Change from base line, on the fifth day	Yes
Secondary	Change of renal function	The renal function includes creatinine,usea nitrogen	Change from base line, on the fifth day	Yes
Secondary	Incidence of ECG abnormalities		Change from base line, on the fifth day	Yes