Multi-center, Randomized, Double Blind and Placebo Controlled Clinical Trial on the Efficacy and Safety of Jinhua Qinggan (JHQG) Granules for the Treatment of Acute Upper Respiratory Infection (Wind-Heat Pattern)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 546
- 试验地点
- 1
- 主要终点
- Clinically Curative Rate after 3 days of medication
研究概览
简要总结
The goal of this clinical trial is to learn if drug Jinhua Qinggan Granules (JHQG) works to treat acute upper respiratory tract infection in adults. It will also learn about the safety of drug JHQG. The main questions it aims to answer is:
• Following three days of treatment, the overall grade of fever, sore throat, nasal congestion, rhinorrhea, headache, sneezing, cough, and malaise dropped to zero for a whole day.
Researchers will compare drug JHQG to a placebo (a look-alike substance that contains no drug) to see if drug JHQG works to treat acute upper respiratory tract infection.
Participants will:
- Take drug JHQG or a placebo 3 times daily for 3 days
- All subjects are followed up before the trial, and on the same day or day after completing 3 days of medication.
详细描述
JHQG is a Chinese patent medicine that is extensively used for the treatment of H1N1. This prescription has demonstrated significant curative effects in combating H1N1 influenza A. JHQG is listed in the COVID-19 Diagnosis and Treatment Guidelines (5th-10thEdition) jointly issued by the National Health Commission and State Administration of Traditional Chinese Medicine.
JHQG is created from the two classical traditional Chinese medicine (TCM) formulae Ma Xing Shi Gan Decoction and Yin Qiao San Decoction, which have a long history of clinical application within the treatment of influenza. According to past reports, JHQG has a great clinical impact on influenza with the symptoms of high fever, headache, aversion to cold, pharyngalgia, sneezing, cough, muscle ache, etc. According to modern pharmacological studies, JHQG also has the anti-inflammatory, antiviral and antibacterial activities.
The objective of this clinical trial is to evaluate the efficacy and safety of Jinhua Qinggan Granules (JHQG) in treating Acute Upper Respiratory Tract Infection (AURI).
Possible potential benefits include soothing wind and dispersing the lung, clearing heat and detoxification, relieving fever, headache, body aches, sore throat and other related symptoms caused by wind-heat invading the lung.
The subjects in accordance with enrollment and non-exclusion criterion will be assigned to Treatment group and Placebo control group according to the ratio of 2:1 using blocked randomization, stratified by country, in which the Placebo control group shall receive JHQG Granules simulation (placebo) agent, while the treatment group will take Jinhua Qinggan Granules.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with AURI;
- •Wind-heat of TCM pattern differentiation;
- •18 ≤Age ≤ 65;
- •At screening, axillary temperature ≥37.3 ºC and ≤39.0 ºC;
- •At randomization and group assignment, disease course within 48 hours;
- •The subject has signed the informed consent form.
排除标准
- •Patients with influenza, COVID-19, suppurative otitis media, suppurative tonsillitis, acute attack of asthma and chronic obstructive pulmonary disease, pulmonary tuberculosis, primary ciliary dyskinesia syndrome, pleural effusion, interstitial lesions, acute and chronic tracheobronchitis, lower respiratory infections such as pneumonia;
- •WBC > 11.0×109 or NEU% > 80% or with symptoms of thick sputum and suspected bacterial infection;
- •ALT, AST > 2 ULN or CRE>ULN;
- •Nasal surgery, nasopharyngeal radiotherapy, acute and chronic nasal diseases or abnormal nasal mucosal function (e.g. rhinitis, sinusitis);
- •Patients with diseases diagnosed by specific pathogens (e.g. mumps, measles, hemorrhagic fever, typhoid, chicken pox, allergic rhinitis);
- •Fever caused by other clearly diagnosed organic diseases outside the respiratory system;
- •Accompanied by cardiovascular diseases (e.g. coronary heart disease, myocarditis, etc., excluding hypertension with stable blood pressure control and asymptomatic old lacunar infarction), major kidney, liver, hematological diseases, major nervous and neuromuscular diseases, major metabolic and endocrine diseases and immunosuppression (including immunosuppressant or HIV infection, etc.), and malignant tumor;
- •Subjects, who were treated with antivirals, antibiotics, western or traditional medicines for alleviating symptoms of upper respiratory infection within 12 hours before enrollment;
- •Allergic individuals and those who are known to be allergic to investigational drugs, including the ingredients of this product, acetaminophen or drug excipients;
- •Women who are pregnant or plan to become pregnant within the next 1 months, lactating women; from signature of informed consent form, until 30 days after the last study medication, patients of childbearing age who are unable or unwilling to use adequate contraception or their spouses are unwilling to use contraception;
- •Suspected or do have a history of alcohol or drug abuse;
- •Participated in other clinical trials or are participating in other clinical trials in the past 3 months;
- •Subjects not suitable for enrollment based on investigators' judgment.
研究组 & 干预措施
Jinhua Qinggan Granules
Participants receive Jinhua Qinggan Granules according to the study protocol.
干预措施: Jinhua Qinggan Granules (Drug)
Placebo
Participants receive placebo matched in appearance to JHQG.
干预措施: Placebo (Drug)
结局指标
主要结局
Clinically Curative Rate after 3 days of medication
时间窗: After 3 Days
Proportion of participants whose Total Symptom Severity Score decreases to 0 and remains 0 for at least 24 consecutive hours after 3 days of medication. The Total Symptom Severity Score is calculated by summing the severity of: Fever, Headache, Sore throat, Nasal congestion, Rhinorrhea, Sneezing, Cough, Malaise Each symptom is graded on a 4-point scale: 0 = none 1. = mild 2. = moderate 3. = severe Total score range: 0 to 24. Higher scores indicate more severe symptoms (worse condition).
次要结局
- Curative effect(After 3 days of medication)
- Change from Baseline in Total Symptom Severity Score(Baseline to after 3 days of medication)
- Time to Defervescence(From first dose up to Day 3)
- Time to Recovery of Individual(From first dose up to Day 3)
- Improvement in Individual Symptoms(Baseline to after 3 days of medication)
- Proportion of Participants Using Acetaminophen(After 3 days of medication)
研究者
Dr. Muhammad Raza Shah
Director-International Center for Chemical and Biological Sciences, University of Karachi
University of Karachi