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| Name | Class |
|---|---|
| The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine | OTHER |
| Affiliated Hospital of Liaoning University of Traditional Chinese Medicine | OTHER |
| Beijing Luhe Hospital | OTHER |
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This is a multicenter, randomized, open Label, add-on study.
This is an add-on study of efficacy and safety of intravenous injection of Xiyanping injection in pediatric subjects with severe Influenza-Like Symptoms.
The purpose to determine the efficacy and safety of Oseltamivir Phosphate combined with or without Xiyanping injection in the treatment of severe Influenza-Like Symptoms. The study will enroll 72 Pediatric severe Influenza-Like Symptoms volunteers, who will be randomized into 2 groups (1:1 ratio): volunteers from the first group will receive Oseltamivir Phosphate and Xiyanping injection for severe Influenza; volunteers from the second group will receive Oseltamivir Phosphate for severe Influenza. Xiyanping injection will be administration as intravenous injection of 0.4mL/kg/day once daily for 7-10 days concomitantly with Oseltamivir Phosphate for severe Influenza-Like Symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Oseltamivir Phosphate+Xiyanping injection | Experimental | Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days |
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| Oseltamivir Phosphate treatment only | Active Comparator | Oseltamivir Phosphate treatment for 7-10 days |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oseltamivir Phosphate | Drug | Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need. |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Alleviation of Influenza Signs and Symptoms | Time to alleviation of influenza signs and symptoms is defined as the length of time taken from the start of treatment to the point at which all of the signs and symptoms are alleviation or recovery. | Up to Day 12 |
| Duration of Fever | Length of time taken by participants to return to afebrile state | Up to Day 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Signs and Symptoms Score from baseline | (1) recovery: symptom score reduction rate ≥ 95%; (2) markedly effective: symptom score reduction rate ≥ 70%; (3) progress: symptom score reduction rate ≥ 30%; (4) invalid: Symptom score reduction rate <30%. | Up to Day 12 |
| Usage of antibiotic,hormone and incidence of critical cases |
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Inclusion Criteria:
Age between 3 and 6 years old;
Clinical diagnosis of Severe Influenza with hospital treatment needed;
Patients did not accept oseltamivir phosphate treatment or symptoms persisted for more than 3 days treatment;
(1)Fever ≥ 39°C (tympanic temperature) for at least 3 days with Severe cough,sputum, blood stasis, or chest pain; (2)Combined pneumonia;
The rapid viral antigen test of throat swab and nose swab results were positive;
Guardians understood and assigned the informed consent;
Exclusion Criteria:
3 to 6 years old hospitalized patient
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xilian Zhang | Contact | 022-27432299 | yfyiec@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting | Tianjin | China |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D053139 | Oseltamivir |
| ID | Term |
|---|---|
| D000081 | Acetamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D053138 | Cyclohexenes |
| D003510 |
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| Qingdao Municipal Hospital | OTHER |
| Cangzhou People's Hospital | OTHER |
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| Xiyanping injection+Oseltamivir Phosphate | Drug | Take the dosage of Oseltamivir Phosphate recommended according to the instructions.Xiyanping injection intravenous administration of 0.4mL/kg/day ,QD for 7-10 days.support treatment such as antiasthmatic, expectorant and antipyretic use only in need. |
|
| Up to Day 12 |
| Time to Cessation of Viral Shedding by RT-PCR | Up to Day 12 |
| Relief time of individual symptom such as:expectoration, cough | Up to Day 12 |
| Disease efficacy criteria | (1) Healing: The body temperature is normal within 48 hours of treatment, the symptoms disappeared without repetition. (2) markedly effective: the body temperature is normal within 48 hours of treatment, and the symptom score is reduced by more than 2/3. (3) Effective: The body temperature is normal within 72 hours of treatment, and the remaining symptom scores are reduced by 2/3-1/3. (4) Invalid: The condition did not improve or worsened after 72 hours of treatment. | Up to Day 12 |
| Imaging improvement rate: number of people with normal or baseline imaging | Up to Day 12 |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |