Skip to content

A study of skin warning on allergic reaction about Traditional Chinese medicine injections

A study of skin warning on allergic reaction about Traditional Chinese medicine injections

Status
Recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR-CPC-15006921
Enrollment
Unknown
Registered
2015-07-03
Start date
2015-07-29
Completion date
Unknown
Last updated
2017-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

skin allergy caused by Chinese medicine injection

Interventions

group 1:Injection with salvia miltiorrhiza phenolic acids more clinical intended use method is: 100 mg, 250 ml, 0.9% sodium chloride injection by intravenous infusion after dissolving, the clinical in
group 2:Lactones ginkgo biloba injection clinical intended use method is: 10 ml (50 mg), 250 ml0. 9% sodium chloride injection by intravenous infusion after dissolving, the clinical infusion concentra
group 3:Ginkgo diterpene lactone meglumine injection clinical intended use method is: 5 ml (including gingko diterpene lactone 25 mg), 250 ml0. 9% sodium chloride injection by intravenous infusion aft

Sponsors

The second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18 to 70 years old, male and female; 2. Meet one of the following conditions: Group 1: never use any salvia miltiorrhiza agents (including injection with salvia miltiorrhiza polyphenols acid); Ever use salvia miltiorrhiza agents (including injection with salvia miltiorrhiza phenolic acids), not happened allergic reaction;Ever use salvia miltiorrhiza agents (including injection with salvia miltiorrhiza phenolic acids), had an allergic reaction;There was a drug allergy reaction;And voluntary informed consent to participate in the subjects. Group 2: never use any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone C preparation (including lactones ginkgo biloba injection);Used any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone C preparation (including lactones ginkgo biloba injection), not happened allergic reaction; Ever use any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone C preparation (including lactones ginkgo biloba injection), allergic reaction has occurred;There was a drug allergy reaction; And voluntary informed consent to participate in the subjects. Group 3: never use any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone K preparations (including ginkgo diterpene lactone meglumine injection); Used any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone K preparations (including ginkgo diterpene lactone meglumine injection), not happened allergic reaction; Ever use any ginkgo lactone, lactones ginkgo, ginkgo lactone B, ginkgo lactone K preparations (including lactones ginkgo biloba injection), allergic reaction has occurred; There was a other drug allergy reaction;And voluntary informed consent to participate in the subjects.

Exclusion criteria

Exclusion criteria: 1. Women who during pregnancy, or lactation,or menstrual; 2. To have an infectious disease, eczema, dermatitis or trauma and infection; 3. In one of the following conditions: two days to use a beta blocker adrenaline; one week used H1 antihistamines, imipramine, phenothiazine, beta adrenergic drugs ; one week used short-term sugar cortical hormone drugs; Local used two weeks of glucocorticoid hormone drugs; Four weeks used long-term glucocorticoid hormone drugs. 4. According to the researchers determine other unfavorable into groups.

Design outcomes

Primary

MeasureTime frame
Different concentrations for injection salvia miltiorrhiza polyphenols acid after skin prick/intradermal test appear allergic reaction rate and the composition of all kinds of positive reaction;

Countries

China

Contacts

Public ContactYanfen Li
liyanfen2008@163.com+86 022-60335723

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 20, 2026