| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Severe Influenza | Drug: Oseltamivir Phosphate Drug: Xiyanping injection+Oseltamivir Phosphate | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 72 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms |
| Actual Study Start Date : | March 4, 2019 |
| Estimated Primary Completion Date : | March 31, 2020 |
| Estimated Study Completion Date : | March 31, 2020 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Oseltamivir Phosphate+Xiyanping injection
Oseltamivir Phosphate+Xiyanping injection treatment for 7-10 days
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Drug: Xiyanping injection+Oseltamivir Phosphate
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.
|
|
Active Comparator: Oseltamivir Phosphate treatment only
Oseltamivir Phosphate treatment for 7-10 days
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Drug: Oseltamivir Phosphate
Take the dosage of Oseltamivir Phosphate recommended according to the instructions.support treatment such as antiasthmatic, expectorant and antipyretic use only in need.
|
| Ages Eligible for Study: | 3 Years to 6 Years (Child) |
| Sexes Eligible for Study: | All |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | 3 to 6 years old hospitalized patient |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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;
Exclusion Criteria:
| Contact: Xilian Zhang | 022-27432299 | yfyiec@163.com |
| China | |
| The First Affliated Hospital of Tianjin University of Traditional Chinese Medicine | Recruiting |
| Tianjin, China | |
| Contact: Xilian Zhang 022-27432299 yfyiec@163.com | |
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date ICMJE | May 8, 2019 | ||||||
| First Posted Date ICMJE | May 13, 2019 | ||||||
| Last Update Posted Date | May 15, 2019 | ||||||
| Actual Study Start Date ICMJE | March 4, 2019 | ||||||
| Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title ICMJE | Evaluate the Safety and Efficacy of Xiyanping in Pediatric Participants With Severe Influenza-Like Symptoms | ||||||
| Official Title ICMJE | A Multicenter, Randomized, Open Label, Add-on Study to Assess Efficacy and Safety of Xiyanping Injection in Pediatric Participants With Severe Influenza-Like Symptoms | ||||||
| Brief Summary | This is a multicenter, randomized, open Label, add-on study. | ||||||
| Detailed Description |
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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| Study Type ICMJE | Interventional | ||||||
| Study Phase ICMJE | Not Applicable | ||||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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| Condition ICMJE | Severe Influenza | ||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status ICMJE | Unknown status | ||||||
| Estimated Enrollment ICMJE |
72 | ||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||
| Estimated Study Completion Date ICMJE | March 31, 2020 | ||||||
| Estimated Primary Completion Date | March 31, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 3 Years to 6 Years (Child) | ||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries ICMJE | China | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number ICMJE | NCT03947411 | ||||||
| Other Study ID Numbers ICMJE | JXQF- XYP-1801 | ||||||
| Has Data Monitoring Committee | Not Provided | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
| Study Sponsor ICMJE | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
| Collaborators ICMJE |
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| Investigators ICMJE | Not Provided | ||||||
| PRS Account | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
| Verification Date | May 2019 | ||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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