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| ID | Type | Description | Link |
|---|---|---|---|
| CTRI/2025/12/099964 | Other Identifier | CDSCO |
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| Name | Class |
|---|---|
| Innvocept Global Solutions Private Limited | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic Urticaria Group | Patients with Chronic Urticaria on the first line of treatment like antihistaminics and not controlled requiring histaglobulin treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection | Drug | Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in clinical improvement as assessed by Urticaria Activity Score (UAS7) | Proportion of patients achieving UAS7 <7 | End of study, approximately 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden): | - Change in the requirement of regular anti-allergic medications (including dose increase/ decrease/or complete discontinuation) from baseline to 2 months. | baseline to 2 months |
| 3. Change in Quality of Life: |
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Inclusion Criteria:
Exclusion Criteria:
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Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr.Saswata Banerjee, Vice President Medical Affairs | Contact | +91 02245043456 | saswata.banerjee@bsvgroup.com | |
| Dr.Falgun Vyas, MBBS, MD | Contact | +91 02245043456 | falgun.vyas@bsvgroup.com |
| Name | Affiliation | Role |
|---|---|---|
| Dr Saswata Banerjee | Bharat serums and Vaccines LTd | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vaishnavis skin Care & Cosmetic | Recruiting | Ahmedabad | Gujarat | 380004 | India |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24223585 | Background | 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. | |
| 38758422 | 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. |
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• Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months. |
| Baseline to 2 months |
| 4. Safety and Tolerability: | Incidence, severity, and relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) and adverse drug reactions (ADRs) during the study period. | Throughout the study period, an average of 1 year |
| Matis Multispeciality Hospital | Recruiting | Ahmedabad | Gujarat | 380005 | India |
|
| L. G. Hospital | Recruiting | Ahmedabad | Gujarat | 380008 | India |
|
| Jupiter Hospital and Research Centre | Recruiting | Vadodara | Gujarat | 390012 | India |
|
| Parikh Multispeciality Hospital | Recruiting | Vadodara | Gujarat | 390020 | India |
|
| DRG Skin Clinic | Recruiting | Faridabad | Haryana | 121010 | India |
|
| Silver Streak Multispeciality Hospital | Recruiting | Gurgaon | Haryana | 122004 | India |
|
| Aarvya Hospital | Recruiting | Gurgaon | Haryana | 122505 | India |
|
| KIMS hospital | Recruiting | Bangalore | Karnataka | 560004 | India |
|
| SkinXperts Super Speciality Skin, Hair and Laser Clinic | Recruiting | Bangalore | Karnataka | 560086 | India |
|
| Medstar Speciality Hospital | Recruiting | Bangalore | Karnataka | 560092 | India |
|
| KR hospital | Recruiting | Mysore | Karnataka | 570001 | India |
|
| Ishwar Institute of Healthcare | Recruiting | Aurangabad | Maharashtra | 431002 | India |
|
| Renukai Critical Care and Multispeciality Hospital | Recruiting | Nanded | Maharashtra | 431602 | India |
|
| D. Y. Patil Medical College and Research Centre | Recruiting | Navi Mumbai | Maharashtra | 400706 | India |
|
| Sai Allergy Asthma Eye Hospital | Recruiting | Pune | Maharashtra | 411009 | India |
|
| Ayushri Multispeciality Hospital. | Recruiting | Pune | Maharashtra | 411017 | India |
|
| Vaidya Skin Care Clinic | Recruiting | Pune | Maharashtra | 411030 | India |
|
| Saikrupa Hospital | Recruiting | Pune | Maharashtra | 411033 | India |
|
| Anand Multispeciality Hospital | Recruiting | Pune | Maharashtra | 411039 | India |
|
| Lifepoint Multispeciality Hospital | Recruiting | Pune | Maharashtra | 411057 | India |
|
| Mediskin Hospital | Recruiting | Pune | Maharashtra | 413102 | India |
|
| Medipoint Hospital | Recruiting | Pune | Maharashtra | India |
|
| Chandni Hospital Private Limited | Recruiting | Kanpur | National Capital Territory of Delhi | 208002 | India |
|
| Dr Astha Sharma Clinic | Recruiting | New Delhi | National Capital Territory of Delhi | 110058 | India |
|
| Dr Vaibhav Skin , Hair and Laser Clinic | Recruiting | New Delhi | National Capital Territory of Delhi | 110058 | India |
|
| Skin & Hair Clinic (Aesthetic Clinic) | Recruiting | New Delhi | National Capital Territory of Delhi | 110058 | India |
|
| Aakash Healthcare Super Speciality Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110075 | India |
|
| Venkateshwar Hospital | Recruiting | New Delhi | National Capital Territory of Delhi | 110075 | India |
|
| Christian Medical Collage & Hospital | Recruiting | Ludhiana | Punjab | 141008 | India |
|
| Jawahar Lal Nehru hospital | Recruiting | Ajmer | Rajasthan | 305001 | India |
|
| SMS Medical Collage and Hospital | Recruiting | Jaipur | Rajasthan | 302004 | India |
|
| Apex Hospital Pvt. Ltd. | Recruiting | Jaipur | Rajasthan | 302017 | India |
|
| Mahatma Gandhi Hospital | Recruiting | Jaipur | Rajasthan | 302022 | India |
|
| Mittal Skin Hair Laser and Cosmetic | Recruiting | Jaipur | Rajasthan | 302039 | India |
|
| Department of Skin & V.D S.P Medical Collage & A.G of Hospital | Recruiting | Kolkata | West Bengal | 700014 | India |
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| Dr Utsa Basu Clinic | Recruiting | Kolkata | West Bengal | 700014 | India |
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| NRS Medical College and Hospital | Recruiting | Kolkata | West Bengal | 700014 | India |
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| Upasana Diagnostic Centre | Recruiting | Kolkata | West Bengal | 700064 | India |
|
| KPL Hospital | Recruiting | Kolkata | West Bengal | 700084 | India |
|
| 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 |
| ID | Term |
|---|---|
| D000080223 | Chronic Urticaria |
| D014581 | Urticaria |
| ID | Term |
|---|---|
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D006633 | Histamine Antagonists |
| D006635 | Histamine H2 Antagonists |
| D020024 | Leukotriene Antagonists |
| D007136 | Immunoglobulins |
| D007150 | Immunohistochemistry |
| D007267 | Injections |
| ID | Term |
|---|---|
| D018494 | Histamine Agents |
| D018377 | Neurotransmitter Agents |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D045505 | Physiological Effects of Drugs |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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