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

• Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection (Drug): Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.

Primary outcomes

• Change in clinical improvement as assessed by Urticaria Activity Score (UAS7) [End of study, approximately 1 year]: Proportion of patients achieving UAS7 <7

Secondary outcomes

• Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden): [baseline to 2 months]: \- Change in the requirement of regular anti-allergic medications (including dose increase/ decrease/or complete discontinuation) from baseline to 2 months.
• 3. Change in Quality of Life: [Baseline to 2 months]: • Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months.
• 4. Safety and Tolerability: [Throughout the study period, an average of 1 year]: Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period.

Sex: All, ages: 13 Years to any

Inclusion Criteria:

1. Male or female patients aged ≥13 years.
2. Able and willing to provide written informed consent (or assent where applicable).
3. Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria
4. Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine car

Exclusion Criteria:

1. Known allergy or hypersensitivity to Histoglob or human immunoglobulin product.
2. Patients with acute allergic attack
3. Pregnant or lactating women.
4. History of malignancy or any condition requiring immunosuppressive therapy other than study indication.
5. Participation in any other clinical study.
6. Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation

• Khan S, Maitra A, Hissaria P, Roy S, Padukudru Anand M, Nag N, Singh H. Chronic urticaria: Indian context-challenges and treatment options. Dermatol Res Pract. 2013;2013:651737. doi: 10.1155/2013/651737. Epub 2013 Sep 24. PMID 24223585
• Friedman A, Kwatra SG, Yosipovitch G. A Practical Approach to Diagnosing and Managing Chronic Spontaneous Urticaria. Dermatol Ther (Heidelb). 2024 Jun;14(6):1371-1387. doi: 10.1007/s13555-024-01173-5. Epub 2024 May 17. PMID 38758422
• Sivanandhan K, Godse K, Pereira C, Patodiya S, Modi G, Banerjee S, Patel H. Immunoglobulin/Histamine Complex in allergic diseases: A systematic review. Int J Pharma Bio Sci. 2025.16.1.p13-39

• Dr Saswata Banerjee, Study director, Bharat serums and Vaccines LTd