RecruitingNCT07680413

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

Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study.


Sponsor

Bharat Serums and Vaccines Limited

Enrollment

600 participants

Start Date

Dec 31, 2025

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 13 Years

Inclusion Criteria4

  • 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 Criteria6

  • 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

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

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

Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.


Locations(40)

Vaishnavis skin Care & Cosmetic

Ahmedabad, Gujarat, India

Matis Multispeciality Hospital

Ahmedabad, Gujarat, India

L. G. Hospital

Ahmedabad, Gujarat, India

Jupiter Hospital and Research Centre

Vadodara, Gujarat, India

Parikh Multispeciality Hospital

Vadodara, Gujarat, India

DRG Skin Clinic

Faridabad, Haryana, India

Silver Streak Multispeciality Hospital

Gurgaon, Haryana, India

Aarvya Hospital

Gurgaon, Haryana, India

KIMS hospital

Bangalore, Karnataka, India

SkinXperts Super Speciality Skin, Hair and Laser Clinic

Bangalore, Karnataka, India

Medstar Speciality Hospital

Bangalore, Karnataka, India

KR hospital

Mysore, Karnataka, India

Ishwar Institute of Healthcare

Aurangabad, Maharashtra, India

Renukai Critical Care and Multispeciality Hospital

Nanded, Maharashtra, India

D. Y. Patil Medical College and Research Centre

Navi Mumbai, Maharashtra, India

Sai Allergy Asthma Eye Hospital

Pune, Maharashtra, India

Ayushri Multispeciality Hospital.

Pune, Maharashtra, India

Vaidya Skin Care Clinic

Pune, Maharashtra, India

Saikrupa Hospital

Pune, Maharashtra, India

Anand Multispeciality Hospital

Pune, Maharashtra, India

Lifepoint Multispeciality Hospital

Pune, Maharashtra, India

Mediskin Hospital

Pune, Maharashtra, India

Medipoint Hospital

Pune, Maharashtra, India

Chandni Hospital Private Limited

Kanpur, National Capital Territory of Delhi, India

Dr Astha Sharma Clinic

New Delhi, National Capital Territory of Delhi, India

Dr Vaibhav Skin , Hair and Laser Clinic

New Delhi, National Capital Territory of Delhi, India

Skin & Hair Clinic (Aesthetic Clinic)

New Delhi, National Capital Territory of Delhi, India

Aakash Healthcare Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, India

Venkateshwar Hospital

New Delhi, National Capital Territory of Delhi, India

Christian Medical Collage & Hospital

Ludhiana, Punjab, India

Jawahar Lal Nehru hospital

Ajmer, Rajasthan, India

SMS Medical Collage and Hospital

Jaipur, Rajasthan, India

Apex Hospital Pvt. Ltd.

Jaipur, Rajasthan, India

Mahatma Gandhi Hospital

Jaipur, Rajasthan, India

Mittal Skin Hair Laser and Cosmetic

Jaipur, Rajasthan, India

Department of Skin & V.D S.P Medical Collage & A.G of Hospital

Kolkata, West Bengal, India

Dr Utsa Basu Clinic

Kolkata, West Bengal, India

NRS Medical College and Hospital

Kolkata, West Bengal, India

Upasana Diagnostic Centre

Kolkata, West Bengal, India

KPL Hospital

Kolkata, West Bengal, India

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07680413