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| Name | Class |
|---|---|
| The General Hospital of Central Theater Command | OTHER |
| The General Hospital of Northern Theater Command | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low dose group | Experimental | 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. |
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| High dose group | Experimental | 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. |
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| Placebo group | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| recombinant human interferon ω spray | Drug | 8 ml/bottle(contain 2 million IU recombinant human interferon ω) |
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| Measure | Description | Time Frame |
|---|---|---|
| Complete antipyretic time | the axillary temperature returns to normal (37.4℃) and remains for 24 h or more. | 0-7 days post each drug use |
| Incidence of adverse reaction (AR) | Incidence of adverse reaction (AR) | 0-14 days post each drug use |
| Measure | Description | Time Frame |
|---|---|---|
| The effective rate of relieving symptoms of upper respiratory tract infection | all symptoms of upper respiratory tract infection(nasal congestion, runny nose, sneezing, sore throat, cough)were alleviated efficiently. Judging the severity of the condition through scoring criteria. | 0-7 days post each drug use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhichun Feng, M.M | Contact | +86(10) 66721786 | zhjfengzc@126.com |
| Name | Affiliation | Role |
|---|---|---|
| Zhichuan Feng, M.M | Seventh Medical Center of PLA General Hospital | Principal Investigator |
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Prospective, randomized, double-blind, double-simulated, placebo parallel-controlled, multicenter design
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| Recovery time |
the time required for complete fever relief and all symptoms to be relieved |
| 0-7 days post each drug use |
| Use rate of antimicrobial drugs and antipyretic drugs | Types and frequency of use of antibacterial and antipyretic drugs | 0-7 days post each drug use |
| Incidence of complications | Incidence of complications | 0-7 days post each drug use |
| Recurrence rate of cured subjects | Recurrence rate of cured subjects | 0-7 days post each drug use |
| Laboratory examination | Changes in laboratory indicators,such as red blood cell count; platelet count; glutamic-pyruvic transaminase; urinary protein and so on. | 0-7 days post each drug use |