Skip to content

A randomized, double-blind, multi-center exploratory clinical study of desloratadine citrate capsules in the treatment of chronic spontaneous urticaria

A randomized, double-blind, multi-center exploratory clinical study of desloratadine citrate capsules in the treatment of chronic urticaria

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200058562
Enrollment
Unknown
Registered
2022-04-11
Start date
2021-09-01
Completion date
Unknown
Last updated
2024-01-08

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 1:Take 8.8mg desloratadine citrate capsules
Group 2:Take 17.6mg desloratadine citrate capsules
Group 3:Take 35.2mg desloratadine citrate capsules

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Aged 18-65 years, no gender limit; 2. Comply with the diagnostic criteria for chronic spontaneous urticaria in the ''Guidelines for Diagnosis and Treatment of Urticaria'', the course of the disease lasts more than 6 weeks, visible urticaria lesions occur at least 3 days a week, and the conventional dose of antihistamines has not been effective in the past. Good medical history; 3. The severity of the disease is moderate to severe, that is, UAS7>=16 points, ISS7>=8 points; and during this period at least 3 days, there are two index scores of pruritus score, wind mass score, and maximum wind mass diameter score >=2 points; 4. Those who are willing and able to complete the daily symptom diary record during the research period; 5. Before the start of the trial, the patient or his legal representative voluntarily signed an informed consent form approved by the ethics committee.

Exclusion criteria

Exclusion criteria: 1. Patients with concomitant diseases or medications (such as corticosteroids, H2 antagonists, non-steroidal anti-inflammatory drugs, anti-leukotriene drugs, anti-sympathetic or central nervous system sedative drugs) that may interfere with their CSU symptoms or increase the risk of adverse reactions; 2. Cholinergic urticaria and other urticaria with clear causes, etc.; 3. Known history of allergy to this drug component; 4. Patients with liver and kidney dysfunction (ALT or AST greater than 2 times the upper limit of normal, creatinine value greater than 1.5 times the upper limit of normal) and autoimmune diseases; 5. Pregnant, lactating patients or patients planning pregnancy; 6. Abnormal ECG parameters (PR, QRS, QT and QTc intervals) have clinical significance (subject to the clinician's judgment); 7. Participated in or is participating in other clinical studies within 1 month prior to the date of obtaining informed consent; 8. Patients considered unsuitable for this clinical study by the investigator.

Design outcomes

Primary

MeasureTime frame
weekly urticaria activity scores;weekly itch-severity scores;

Secondary

MeasureTime frame
visual analogue scale;

Countries

China

Contacts

Public ContactCui Yong
wuhucuiyong@vip.163.com+86 15701625913

Outcome results

None listed

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