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

NCT07680413 | Completed

• 2 other identifiers: BSV/HIST/01/2025CTRI/2025/12/099964
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 40

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.

Conditions

Chronic Urticaria

Keywords

Histoglob; urticaria; histaglobulin; Chronic urticaria; RWE study; antihistaminics

Outcome Measures

Primary Outcomes (1)

• Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)

  Proportion of patients achieving UAS7 \<7

  End of study, approximately 1 year

Secondary Outcomes (3)

• Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):

  baseline to 2 months

• 3. Change in Quality of Life:

  Baseline to 2 months

• 4. Safety and Tolerability:

  Throughout the study period, an average of 1 year

Study Arms (1)

Chronic Urticaria Group

Patients with Chronic Urticaria on the first line of treatment like antihistaminics and not controlled requiring histaglobulin treatment

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

Interventions

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

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

Chronic Urticaria Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bharat Serums and Vaccines Limited: lead
• Innvocept Global Solutions Private Limited: collaborator

Study Sites (40)

Vaishnavis skin Care & Cosmetic

Ahmedabad, Gujarat, 380004, India

Location

Matis Multispeciality Hospital

Ahmedabad, Gujarat, 380005, India

Location

L. G. Hospital

Ahmedabad, Gujarat, 380008, India

Location

Jupiter Hospital and Research Centre

Vadodara, Gujarat, 390012, India

Location

Parikh Multispeciality Hospital

Vadodara, Gujarat, 390020, India

Location

DRG Skin Clinic

Faridabad, Haryana, 121010, India

Location

Silver Streak Multispeciality Hospital

Gurgaon, Haryana, 122004, India

Location

Aarvya Hospital

Gurgaon, Haryana, 122505, India

Location

KIMS hospital

Bangalore, Karnataka, 560004, India

Location

SkinXperts Super Speciality Skin, Hair and Laser Clinic

Bangalore, Karnataka, 560086, India

Location

Medstar Speciality Hospital

Bangalore, Karnataka, 560092, India

Location

KR hospital

Mysore, Karnataka, 570001, India

Location

Ishwar Institute of Healthcare

Aurangabad, Maharashtra, 431002, India

Location

Renukai Critical Care and Multispeciality Hospital

Nanded, Maharashtra, 431602, India

Location

D. Y. Patil Medical College and Research Centre

Navi Mumbai, Maharashtra, 400706, India

Location

Sai Allergy Asthma Eye Hospital

Pune, Maharashtra, 411009, India

Location

Ayushri Multispeciality Hospital.

Pune, Maharashtra, 411017, India

Location

Vaidya Skin Care Clinic

Pune, Maharashtra, 411030, India

Location

Saikrupa Hospital

Pune, Maharashtra, 411033, India

Location

Anand Multispeciality Hospital

Pune, Maharashtra, 411039, India

Location

Lifepoint Multispeciality Hospital

Pune, Maharashtra, 411057, India

Location

Mediskin Hospital

Pune, Maharashtra, 413102, India

Location

Medipoint Hospital

Pune, Maharashtra, India

Location

Chandni Hospital Private Limited

Kanpur, National Capital Territory of Delhi, 208002, India

Location

Dr Astha Sharma Clinic

New Delhi, National Capital Territory of Delhi, 110058, India

Location

Dr Vaibhav Skin , Hair and Laser Clinic

New Delhi, National Capital Territory of Delhi, 110058, India

Location

Skin & Hair Clinic (Aesthetic Clinic)

New Delhi, National Capital Territory of Delhi, 110058, India

Location

Aakash Healthcare Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, 110075, India

Location

Venkateshwar Hospital

New Delhi, National Capital Territory of Delhi, 110075, India

Location

Christian Medical Collage & Hospital

Ludhiana, Punjab, 141008, India

Location

Jawahar Lal Nehru hospital

Ajmer, Rajasthan, 305001, India

Location

SMS Medical Collage and Hospital

Jaipur, Rajasthan, 302004, India

Location

Apex Hospital Pvt. Ltd.

Jaipur, Rajasthan, 302017, India

Location

Mahatma Gandhi Hospital

Jaipur, Rajasthan, 302022, India

Location

Mittal Skin Hair Laser and Cosmetic

Jaipur, Rajasthan, 302039, India

Location

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

Kolkata, West Bengal, 700014, India

Location

Dr Utsa Basu Clinic

Kolkata, West Bengal, 700014, India

Location

NRS Medical College and Hospital

Kolkata, West Bengal, 700014, India

Location

Upasana Diagnostic Centre

Kolkata, West Bengal, 700064, India

Location

KPL Hospital

Kolkata, West Bengal, 700084, India

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Chronic Urticaria; Urticaria

Interventions

Histamine Antagonists; Histamine H2 Antagonists; Leukotriene Antagonists; Immunoglobulins; Immunohistochemistry; Injections

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Histocytochemistry; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Immunologic Techniques; Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Dr Saswata Banerjee

  Bharat serums and Vaccines LTd

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2026
• First Posted: July 2, 2026
• Study Start: December 31, 2025
• Primary Completion: August 3, 2026
• Study Completion: August 3, 2026
• Last Updated: October 2, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

IN (40)