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
|
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
|
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 |
|
||||||
Original Primary Outcome Measures ICMJE | Same as current | ||||||
Change History | |||||||
Current Secondary Outcome Measures ICMJE |
|
||||||
Original Secondary Outcome Measures ICMJE |
|
||||||
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. |
||||||
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 |
||||||
Condition ICMJE | Severe Influenza | ||||||
Intervention ICMJE |
|
||||||
Study Arms ICMJE |
|
||||||
Publications * | Not Provided | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||
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:
|
||||||
Sex/Gender ICMJE |
|
||||||
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 |
|
||||||
IPD Sharing Statement ICMJE |
|
||||||
Responsible Party | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
Study Sponsor ICMJE | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
Collaborators ICMJE |
|
||||||
Investigators ICMJE | Not Provided | ||||||
PRS Account | Jiangxi Qingfeng Pharmaceutical Co. Ltd. | ||||||
Verification Date | May 2019 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |