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Allergic pretest for vitexin injection

Allergic pretest for vitexin injection

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900022541
Enrollment
Unknown
Registered
2019-04-16
Start date
2019-04-22
Completion date
Unknown
Last updated
2019-04-23

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

Conditions

Used for chest tightness and pain caused by blood stasis

Interventions

Group 1:prick test
Group 2:Intradermal injection

Sponsors

Xiyuan Hospital, China Academy of Chinese Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 50 Years

Inclusion criteria

Inclusion criteria: (1) Voluntary participation in clinical trials, signing informed consent form and compliance with the trial process; (2) Age between 18-50 years old, both men and women (not less than 1/3 female subjects); (3) The body mass index between 19-26 kg/m2, the male body weight is not less than 50 kg, and the female body weight is not less than 45 kg; (4) The investigator determines healthy subjects based on their medical history, comprehensive physical examination, laboratory tests, ECG, and vital signs examination; (5) Inclusion of not less than 1/4 subjects with a history of allergies (including food allergies, drug allergies, allergic diseases, etc.).

Exclusion criteria

Exclusion criteria: 1. Those who cannot accept food and beverage restrictions during the course of the trial; 2. Those who have had a history of severe allergies (such as anaphylactic shock); 3. Those who have a clinical history that clearly meets the following diseases (including, but not limited to gastrointestinal tract, cardiovascular, musculoskeletal system, endocrine system, blood system, mental illness, kidney, liver, bronchus, neurological disease, immune system, Lipid metabolism disorder); 4. Those who have a positive urine substance abuse test or have a history of drug abuse, such as soft drugs (e.g. Ecstasy, KEN powder, Methamphetamine tablets, etc.) or hard drugs (e.g.cocaine, heroin, crystal meth, etc.) used within one year before the test; 5. Those who test positive for alcohol echalation; 6. Any of the following tests are positive in Screening test: HIV antibody positive, syphilis specific antibody positive, hepatitis B surface antigen (HBsAg) positive, hepatitis C antibody positive; 7. Positive pregnancy test (blood pregnancy/urine pregnancy) or lactating women; all fertile male and female subjects cannot accept physical contraception for themselves and their partners during the trial period; who had a fertility plan for themselves and their partners within 6 months of the end of the trial and were unwilling to take appropriate and effective contraception; 8. One of the following conditions is met: (1) Those who have used beta adrenergic blockers within 2 days; (2) Those who have used H1 antihistamine, imipramine, phenothiazine, ß-adrenalin and other drugs within 1 week; (3) Those who have used short-acting glucocorticoids within 1 week; (4) Those who have used glucocorticoids within 2 weeks; (5) Those who have used long-acting glucocorticoids within 4 weeks. 9. A history of hospitalization or surgery within the first 3 months of screening; 10. Participate in other drug clinical trials within the first 3 months of screening; (11) The investigator believes that there are any situations that may influence subject to provide informed consent form or follow the protocol, or other circumstances in which the subject's participation may affect the outcome of the trial or their own safety.

Design outcomes

Primary

MeasureTime frame
Average wheal diameter ratio (prick test);Average wheal diameter (Intradermal injection);

Countries

China

Contacts

Public ContactRui Gao / Rui Li

Xiyuan Hospital, China Academy of Chinese Medical Sciences

ruigao@126.com+86 010-63825653

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026