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Gubenkangmin Granules for chronic spontaneous urticaria: a randomised double-blind, placebo-controlled clinical trial

Gubenkangmin Granules for chronic spontaneous urticaria: a randomised double-blind, placebo-controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR1900023452
Enrollment
Unknown
Registered
2019-05-28
Start date
2019-06-06
Completion date
Unknown
Last updated
2019-06-03

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

Conditions

Chronic urticaria

Interventions

Sponsors

Guangdong Provincial Hospital of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All

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

Countries

China

Contacts

Public ContactJie Guo

Guangdong Provincial Hosptial of Chinese Medicine

1016877723@qq.com+86 15013075252

Outcome results

None listed

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