Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age13+
SponsorBharat Serums and Vaccines Limited

About this trial

This is a prospective, multicentre, non-interventional, observational, real-world evidence (RWE) study designed to evaluate the effectiveness and safety of Immunoglobulin/Histamine Complex (IHC) in patients with Chronic Urticaria in India.

Eligibility criteria

Qualifiers

Male or female patients aged ≥13 years.

Able and willing to provide written informed consent (or assent where applicable).

Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria

Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car

Disqualifiers

Known allergy or hypersensitivity to Histoglob or human immunoglobulin product.

Patients with acute allergic attack

Pregnant or lactating women.

History of malignancy or any condition requiring immunosuppressive therapy other than study indication.

Trial design

Treatments tested in this trial

  • Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection

Treatment groups

600 Participants
are divided into 1 treatment group

Sponsors and collaborators

Bharat Serums and Vaccines Limited

Lead sponsor

Innvocept Global Solutions Private Limited

Collaborator