Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria
RUSH
2 other identifiers
observational
600
1 country
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Dec 2025
Shorter than P25 for all trials
40 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 31, 2025
CompletedFirst Submitted
Initial submission to the registry
June 6, 2026
CompletedFirst Posted
Study publicly available on registry
July 2, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
July 2, 2026
June 1, 2026
8 months
June 6, 2026
June 25, 2026
Conditions
Keywords
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
Interventions
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (40)
Vaishnavis skin Care & Cosmetic
Ahmedabad, Gujarat, 380004, India
Matis Multispeciality Hospital
Ahmedabad, Gujarat, 380005, India
L. G. Hospital
Ahmedabad, Gujarat, 380008, India
Jupiter Hospital and Research Centre
Vadodara, Gujarat, 390012, India
Parikh Multispeciality Hospital
Vadodara, Gujarat, 390020, India
DRG Skin Clinic
Faridabad, Haryana, 121010, India
Silver Streak Multispeciality Hospital
Gurgaon, Haryana, 122004, India
Aarvya Hospital
Gurgaon, Haryana, 122505, India
KIMS hospital
Bangalore, Karnataka, 560004, India
SkinXperts Super Speciality Skin, Hair and Laser Clinic
Bangalore, Karnataka, 560086, India
Medstar Speciality Hospital
Bangalore, Karnataka, 560092, India
KR hospital
Mysore, Karnataka, 570001, India
Ishwar Institute of Healthcare
Aurangabad, Maharashtra, 431002, India
Renukai Critical Care and Multispeciality Hospital
Nanded, Maharashtra, 431602, India
D. Y. Patil Medical College and Research Centre
Navi Mumbai, Maharashtra, 400706, India
Sai Allergy Asthma Eye Hospital
Pune, Maharashtra, 411009, India
Ayushri Multispeciality Hospital.
Pune, Maharashtra, 411017, India
Vaidya Skin Care Clinic
Pune, Maharashtra, 411030, India
Saikrupa Hospital
Pune, Maharashtra, 411033, India
Anand Multispeciality Hospital
Pune, Maharashtra, 411039, India
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057, India
Mediskin Hospital
Pune, Maharashtra, 413102, India
Medipoint Hospital
Pune, Maharashtra, India
Chandni Hospital Private Limited
Kanpur, National Capital Territory of Delhi, 208002, India
Dr Astha Sharma Clinic
New Delhi, National Capital Territory of Delhi, 110058, India
Dr Vaibhav Skin , Hair and Laser Clinic
New Delhi, National Capital Territory of Delhi, 110058, India
Skin & Hair Clinic (Aesthetic Clinic)
New Delhi, National Capital Territory of Delhi, 110058, India
Aakash Healthcare Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110075, India
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075, India
Christian Medical Collage & Hospital
Ludhiana, Punjab, 141008, India
Jawahar Lal Nehru hospital
Ajmer, Rajasthan, 305001, India
SMS Medical Collage and Hospital
Jaipur, Rajasthan, 302004, India
Apex Hospital Pvt. Ltd.
Jaipur, Rajasthan, 302017, India
Mahatma Gandhi Hospital
Jaipur, Rajasthan, 302022, India
Mittal Skin Hair Laser and Cosmetic
Jaipur, Rajasthan, 302039, India
Department of Skin & V.D S.P Medical Collage & A.G of Hospital
Kolkata, West Bengal, 700014, India
Dr Utsa Basu Clinic
Kolkata, West Bengal, 700014, India
NRS Medical College and Hospital
Kolkata, West Bengal, 700014, India
Upasana Diagnostic Centre
Kolkata, West Bengal, 700064, India
KPL Hospital
Kolkata, West Bengal, 700084, India
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: 24223585BACKGROUNDFriedman 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: 38758422BACKGROUNDSivanandhan 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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Dr Saswata Banerjee
Bharat serums and Vaccines LTd
Central Study Contacts
Dr.Saswata Banerjee, Vice President Medical Affairs
CONTACT
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 (Estimated)
September 1, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
July 2, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share