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| Name | Class |
|---|---|
| Beijing Bionovo Medicine Development Co., Ltd. | OTHER |
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This pilot study is designed to explore the optimal concentration and method of Ginkgolides Meglumine Injection skin testing and to evaluate the value of skin test in predicting any possible allergic reactions to Ginkgolides Meglumine Injection.
Subjects will be enrolled in one of three groups with different doses to receive skin prick testing. Then they may be arranged to receive intradermal, subcutaneous injection or intravenous tests with different doses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.1mg/ml Ginkgolides Meglumine Injection | Experimental | Injection, 0.1mg/ml. |
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| 1mg/ml Ginkgolides Meglumine Injection | Experimental | Injection, 1mg/ml. |
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| 5mg/ml Ginkgolides Meglumine Injection | Experimental | Injection, 5mg/ml. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 0.1mg/ml Ginkgolides Meglumine Injection | Drug |
| ||
| 1mg/ml Ginkgolides Meglumine Injection |
| Measure | Description | Time Frame |
|---|---|---|
| The rate of allergic reaction and analyze all kinds of positive reactions after skin prick test with different doses of Ginkgolides Meglumine Injection. | 15-20 minutes after skin prick tests. | |
| The rate of allergic reaction and analyze all kinds of positive reactions after using intradermal tests of different doses of Ginkgolides Meglumine Injection. | 15-20 minutes after intradermal tests. |
| Measure | Description | Time Frame |
|---|---|---|
| The specificity and sensitivity with the different doses. | Specificity (SPC) =TN/ (FP+TN); Sensitivity=TP/ (TP+FN). TP (true positive); TN (true negative); FP (false positive); FN (false negative). TP(true positive); TN(true negative); FP(false positive); FN(false negative). | 15-20 minutes after prick-puncture and intradermal tests, 72 hours after subcutaneous test. |
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Inclusion Criteria:
Male and female between the ages of 18 and 70(inclusive)at the time of signing the Informed Consent Form （ICF）.
Subjects meet any one of the following requirements
Willingness to participate in the study as evidenced by signing the informed consent form.
Exclusion Criteria:
Women in breastfeeding,menstrual or pregnancy period.
Subjects are in the infectious disease, eczema, dermatitis, trauma,etc.
Subjects meet any one of the following conditions
Subjects are currently participating or have participated in any other clinical trials within the prior 1 month of signing the ICF.
Subjects have a history of allergic shock.
Subjects who are not suitable for this clinical trial at the discretion of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Yuhong Huang | Second Affiliated Hospital of Tianjin University of TCM | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital of Tianjin University of TCM | Tianjin | 300150 | China |
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| ID | Term |
|---|---|
| D006967 | Hypersensitivity |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
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| Drug |
|
| 5mg/ml Ginkgolides Meglumine Injection | Drug |
|
| Safety assessment will be based on adverse event reports, electrocardiogram, physical examinations and clinical laboratory tests. | Only the participants who are allergic to the main components of Ginkgolides Meglumine Injection will be assessed in 3-10 days after using it by the investigators.. | within 7days before using Ginkgolides Meglumine Injectionand 3-10 days after using it. |