A Prospective, Randomized, Double-blind, Double-simulated, Placebo Parallel-controlled, Multicenter Clinical Study on Safety and Efficacy of Recombinant Human Interferon ω Spray in Treatment of Viral Upper Respiratory Tract Infection in Children
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 345
- 主要终点
- Incidence of adverse reaction (AR)
研究概览
简要总结
To evaluate the clinical efficacy and safety of recombinant human interferon ω spray in treatment of viral upper respiratory tract infection in children aged by 3-12 years, and to explore the appropriate usage and dosage of the drug in treatment of upper respiratory tract infection caused by viruses.
详细描述
This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study. Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled. The study contained 3 treatment groups. Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group. This study is a prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multi-center clinical study. Children who met the inclusion criteria of viral upper respiratory tract infection in eligible children aged by 3-12 years will be enrolled. The study contained 3 treatment groups. Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli were used as symptomatic treatment drugs in each group, and the two test groups additionally added to different doses of recombinant human interferon ω spray, placebo was added to the placebo group. In each group, each bottle of drug was sprayed 1 time, sprayed into the child's pharynx, 2 times/dayand should not eat or drink for 20 minutes after using the medicine, Xiao'er Chaigui Tuire Keli and Xiao'er Feire Kechuan Keli should be taken orally according to the doctor's instructions. The treatment period is 7 days. All subjects returned to the study site for evaluating the primary efficacy measures, secondary efficacy measures and safety measures on Treatment Day 7±1. Telephone follow-up was performed on Treatment Day 14±2.
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
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •3 years old ≤ age ≤ 12 years old, gender unlimited；
- •Routine blood test of white cells < Upper limit of normal value, C reactive protein < Upper limit of normal value. Meeting the description of the diagnostic criteria for viral upper respiratory tract infection in Zhufutang Practical Pediatrics；
- •Body temperature ≥ 38 ℃（axillary temperature）；
- •The guardian should give informed consent and sign the informed consent form (if the child is ≥ 10 years old, the child should also give informed consent and sign the informed consent form).
排除标准
- •Diagnosed as bacterial upper respiratory tract infection.
- •Patients with onset time more than 72 hours.
- •With severe cardiac, hepatic and renal insufficiency（ALT and AST are 1.5 times above the upper limit of normal value）, abnormal renal function（Scr abnormality） .
- •Treated with antiviral drugs orally within two weeks or for external use within one week before inclusion.
- •Participated in other clinical trials and took the study medication within one month before inclusion.
- •People with low immune function, systemic failure or long-term use of glucocorticoids and immunosuppressants.
- •Those who suffer from nervous and mental diseases and cannot cooperate well.
- •Allergy constitution（allergic to more than two kinds of drugs or food）or known allergy to interferon and its matrix.
- •Because of other diseases that affect the efficacy observer of this study.
- •Other conditions considered by the investigator as not appropriate to participate in the study.
研究组 & 干预措施
Low dose group
1 bottle of recombinant human interferon ω spray and 1 bottle of placebo（recombinant human interferon ω spray mimics）+base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.
干预措施: recombinant human interferon ω spray (Drug)
High dose group
2 bottle of recombinant human interferon ω spray +base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.
干预措施: recombinant human interferon ω spray (Drug)
Placebo group
2 bottle of placebo（recombinant human interferon ω spray mimics）+base drugs（Xiao'er Changui Tuire granules and Xiao'er Feire Kechuan granules). Each bottle of medication is sprayed once, twice a day. After using the medication, no food or water can be consumed for 20 minutes. Follow the doctor's instructions for use of the base drugs. This treatment course can last up to 7 days.
干预措施: recombinant human interferon ω spray (Drug)
结局指标
主要结局
Incidence of adverse reaction (AR)
时间窗: 0-14 days post each drug use
Incidence of adverse reaction (AR)
Complete antipyretic time
时间窗: 0-7 days post each drug use
the axillary temperature returns to normal （37.4℃） and remains for 24 h or more.
次要结局
- Incidence of complications(0-7 days post each drug use)
- Use rate of antimicrobial drugs and antipyretic drugs(0-7 days post each drug use)
- Recurrence rate of cured subjects(0-7 days post each drug use)
- Laboratory examination(0-7 days post each drug use)
- The effective rate of relieving symptoms of upper respiratory tract infection(0-7 days post each drug use)
- Recovery time(0-7 days post each drug use)