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

ClinicalTrials.gov ID

NCT07680413

Lead Sponsor

Bharat Serums and Vaccines LimitedINDUSTRY

Overall Status

Recruiting

Study Type

Observational

Enrollment

600Estimated

Last Update Posted

Jul 2, 2026Actual

Start Date

Dec 31, 2025Actual

Primary Completion Date

Sep 2026Estimated

Completion Date

Nov 2026Estimated

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.

Brief Summary

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.

• Chronic Urticaria

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

Ages Eligible for Study

Child (0-17)Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Observational Model

Case-Only

Time Perspective

Prospective

Lead Sponsor

Bharat Serums and Vaccines LimitedINDUSTRY

Collaborators

Innvocept Global Solutions Private LimitedOTHER

ishanpandya29@gmail.com98240727535

dranvitasolanki@gmail.com9660604041

drkalpeshkharvanm@gmail.com9925059377

ruchikagarg144@gmail.com9582354366

drurvi77@gmail.com8800827110

kimsowmya@gmail.com9611116181

drmonikagowda.medstar@gmail.com9884457106

drsatishkeshav@gmail.com9886400414

drpvaidya@gmail.com9822400964

skresearch07@gmail.com8669665033

drrashmi77.reserach@gmail.com9742256888

drkokanepriyanka@gmail.com8600386300

drpoonam.medipoint@gmail.com9727800909

drkothiwala@gmail.com9414118811

drneetusidana95@gmail.com9829335095

m.nijhawan12@gmail.com9314503401

dubclinicalresearchcenter@gmail.com9432658968

ipodder88@gmail.com9007977161

anupamdasdr@gmail.com9674852138

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