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Gubenkangmin granules (Gubenxiaozhen granules) for Chronic spontaneous urticaria: a randomised double-blind, placebo-controlled clinical trial

Gubenkangmin granules (Gubenxiaozhen granules) for Chronic spontaneous urticaria: a randomised double-blind, placebo-controlled clinical trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR-IOR-17011785
Enrollment
Unknown
Registered
2017-06-28
Start date
2017-06-01
Completion date
Unknown
Last updated
2017-08-21

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

Conditions

Chronic spontaneous urticaria

Interventions

Group B:Placebo
Group A:Gubenxiaozhen granule

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients who meet the chronic spontaneous urticaria diagnosis creteria; 2. Male and female aged 18 to 65 years old; 3. Patients with syndrome pattern of Wei qi deficiency; 4. UAS7=7; 5. To be able to and willing to provide signed informed consent.

Exclusion criteria

Exclusion criteria: 1. The occurrence of chronic urticaria is severe, such as the appearance of chest stuffy, wheezing, breathing difficulties, and the choking of the laryngeal mucosa. Accompanied by high fever, cold war,tachycardia, etc.; 2. Pregnant,lactating women or pregnancy is planned in half a year; 3. Patients with psychiatric disorders; 4. Patients with other skin diseases that require treatment currently, With history of primary cardiovascular, respiratory, digestive, urinary, endocrinologic and hematologic diseases, which can't be controlled through ordinary treatments.patients with malignant tumor. Patients with clinical test results listed below: AST or ALT 3 times more than normal upper limit; Creatinine 3 times more than normal upper limit;Or any other abnormal laboratory test results, assessed by investigators, that are not suitable for this clinical study; 5. Topical treatments with antihistamines or chinese medicine within 1 week; Oral hormones and other immunosuppressive drugs, immunoglobulins and autohemotherapy within 4 weeks; biological therapy or inject glucocorticoid drugs within 12 weeks; 6. Allergic to this drug ingredient; 7. Participating other clinical trials or participated within 3 months; 8. Workers engaged in highly concentrated attention (driving machines, cars, ships, high-altitude work, mechanical assignments, and precision instruments) 9.Patients who are unfit to enter the group according to doctor's judgment

Design outcomes

Primary

MeasureTime frame
Weekly Urticaria Activity Score;

Secondary

MeasureTime frame
Weekly itch score;Weekly hive score;Propotion of a reduction of weekly UAS to 40% of baseline;time to relapse;relapse rate;Dermatology Quality Life Index;The use of western medicine;

Countries

China

Contacts

Public ContactLu Chuanjian

Guangdong Provincial Hosptial of Chinese Medicine

luchuanjian888@vip.sina.com+86 13822250116

Outcome results

None listed

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