Recruiting NCT07680413
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection.
- Who it may be relevant to
- Registry conditions: Chronic Urticaria. Basic parameters: from 13 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- India
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study.
Overview
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.
Interventions
- Drug Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
Primary outcome measures
- Change in clinical improvement as assessed by Urticaria Activity Score (UAS7) [Time frame: End of study, approximately 1 year]
Secondary outcome measures (3)
- Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden): [Time frame: baseline to 2 months]
- 3. Change in Quality of Life: [Time frame: Baseline to 2 months]
- 4. Safety and Tolerability: [Time frame: Throughout the study period, an average of 1 year]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
- Participation in any other clinical study.
- Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
India · 40 centers
- Vaishnavis skin Care & Cosmetic — Ahmedabad
- Matis Multispeciality Hospital — Ahmedabad
- L. G. Hospital — Ahmedabad
- Jupiter Hospital and Research Centre — Vadodara
- Parikh Multispeciality Hospital — Vadodara
- DRG Skin Clinic — Faridabad
- Silver Streak Multispeciality Hospital — Gurgaon
- Aarvya Hospital — Gurgaon
- … and 32 more centers
Publications
- 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
Identifiers
NCT: NCT07680413 · BSV/HIST/01/2025 · CTRI/2025/12/099964