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Clinical efficacy and safety of Luofushan Baicao oil in the treatment of mosquito bites: a single center clinical study with a positive drug matching design

Clinical efficacy and safety of Luofushan Baicao oil in the treatment of mosquito bites: a single center clinical study with a positive drug matching design

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200066619
Enrollment
Unknown
Registered
2022-12-12
Start date
2022-12-14
Completion date
Unknown
Last updated
2024-11-18

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

Conditions

Mosquito bites

Interventions

Group 1:Luofushan Baicao Oil
Group 2:Essential balm

Sponsors

Guangdong Provincial Hospital of Traditional Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years

Inclusion criteria

Inclusion criteria: 1. 18 years old <= age <= 45 years old, male or female; 2. Symptoms of itching, erythema, papules or wheals corresponding to mosquito bites; 3. Voluntarily participate in the experiment and sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1. Patients suffering from allergic reactions or allergic reactions; 2. Patients who have taken glucocorticoids within two weeks and patients with systemic complications caused by mosquito bites; 3. Patients with concomitant diseases; 4. Female subjects who are pregnant, lactating or have a positive pregnancy test; 5. Those who have a history of drug abuse within 6 months before screening; history of alcoholism (alcoholism is defined as drinking 14 units of alcohol per week: 1 unit = 285 mL of beer, or 25 mL of spirits, or 100 mL of wine); 6. Smokers; 7. Those who are using insecticidal water, mosquito repellent water, toilet water, perfume, etc.; 8. Participated in any other clinical trials of drugs or medical devices within 3 months before screening; 9. Those who are allergic to the experimental drug, or have allergic constitution, such as allergic dermatitis, eczema, papular urticaria, etc.; 10. The investigator believes that any other reasons that may affect the efficacy and/or safety evaluation of this study are not suitable for participating in this clinical trial (including but not limited to the investigator's judgment that the subject's compliance is poor, etc.).

Design outcomes

Primary

MeasureTime frame
Time of first disappearance of itching symptoms within 3h after administration;Diameter change value of erythema, papule or wheal symptoms after 3h of administration;Time of disappearance of erythema, papule or wheal symptoms and frequency of itching symptoms within 24h after administration;Frequency of use of test drug within 24h;

Countries

China

Contacts

Public ContactHongyi Li

Guangdong Provincial Hospital of Traditional Chinese Medicine

lihongyich@126.com+86 136 0228 5656

Outcome results

None listed

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