Chronic UrticariaRUSHNCT07680413
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex, IHC (Histoglob) in Chronic Urticaria
An observational study of Chronic Urticaria, run by Bharat Serums and Vaccines Limited at 40 sites in India.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Chronic Urticaria
- What is being tested?
- Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
- Type of treatment
- Injection or infusion
- How many people
- 660 participants
- Where
- 40 sitesIndia
- Study dates
- 31 Dec 2025to 3 Aug 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
40 sites in 1 country.
40 sites in 1 country
India40 sites
Vaishnavis skin Care & Cosmetic
Ahmedabad, Gujarat, 380004
Matis Multispeciality Hospital
Ahmedabad, Gujarat, 380005
L. G. Hospital
Ahmedabad, Gujarat, 380008
Jawahar Lal Nehru hospital
Ajmer, Rajasthan, 305001
KIMS hospital
Bangalore, Karnataka, 560004
SkinXperts Super Speciality Skin, Hair and Laser Clinic
Bangalore, Karnataka, 560086
Medstar Speciality Hospital
Bangalore, Karnataka, 560092
Ishwar Institute of Healthcare
Chhatrapati Sambhajinagar, Maharashtra, 431002
DRG Skin Clinic
Faridabad, Haryana, 121010
Silver Streak Multispeciality Hospital
Gurgaon, Haryana, 122004
Aarvya Hospital
Gurgaon, Haryana, 122505
SMS Medical Collage and Hospital
Jaipur, Rajasthan, 302004
Apex Hospital Pvt. Ltd.
Jaipur, Rajasthan, 302017
Mahatma Gandhi Hospital
Jaipur, Rajasthan, 302022
Mittal Skin Hair Laser and Cosmetic
Jaipur, Rajasthan, 302039
Chandni Hospital Private Limited
Kanpur, National Capital Territory of Delhi, 208002
Department of Skin & V.D S.P Medical Collage & A.G of Hospital
Kolkata, West Bengal, 700014
Dr Utsa Basu Clinic
Kolkata, West Bengal, 700014
NRS Medical College and Hospital
Kolkata, West Bengal, 700014
Upasana Diagnostic Centre
Kolkata, West Bengal, 700064
KPL Hospital
Kolkata, West Bengal, 700084
Christian Medical Collage & Hospital
Ludhiana, Punjab, 141008
KR hospital
Mysore, Karnataka, 570001
Renukai Critical Care and Multispeciality Hospital
Nanded, Maharashtra, 431602
D. Y. Patil Medical College and Research Centre
Navi Mumbai, Maharashtra, 400706
Dr Astha Sharma Clinic
New Delhi, National Capital Territory of Delhi, 110058
Dr Vaibhav Skin , Hair and Laser Clinic
New Delhi, National Capital Territory of Delhi, 110058
Skin & Hair Clinic (Aesthetic Clinic)
New Delhi, National Capital Territory of Delhi, 110058
Aakash Healthcare Super Speciality Hospital
New Delhi, National Capital Territory of Delhi, 110075
Venkateshwar Hospital
New Delhi, National Capital Territory of Delhi, 110075
Sai Allergy Asthma Eye Hospital
Pune, Maharashtra, 411009
Ayushri Multispeciality Hospital.
Pune, Maharashtra, 411017
Vaidya Skin Care Clinic
Pune, Maharashtra, 411030
Saikrupa Hospital
Pune, Maharashtra, 411033
Anand Multispeciality Hospital
Pune, Maharashtra, 411039
Lifepoint Multispeciality Hospital
Pune, Maharashtra, 411057
Mediskin Hospital
Pune, Maharashtra, 413102
Medipoint Hospital
Pune, Maharashtra
Jupiter Hospital and Research Centre
Vadodara, Gujarat, 390012
Parikh Multispeciality Hospital
Vadodara, Gujarat, 390020
About this study
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.
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
- Being tested
- Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection
- Keywords
- Histoglob, urticaria, histaglobulin, Chronic urticaria, RWE study, antihistaminics
- Medical subject headings
- Chronic Urticaria, Urticaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) InjectionDrug
Histaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose.
| Study group | Role | What they receive |
|---|---|---|
| Chronic Urticaria Group | Patients with Chronic Urticaria on the first line of treatment like antihistaminics and not controlled requiring histaglobulin treatment Receives: Drug: Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
Proportion of patients achieving UAS7 <7
Measured: End of study, approximately 1 year
Secondary outcomes (3)
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.
Measured: baseline to 2 months
3. Change in Quality of Life:
- Proportion of patients showing improvement in Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL) score from baseline to 2 months.
Measured: 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.
Measured: Throughout the study period, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2026
- Study start31 Dec 2025
- Primary completion3 Aug 2026
- Study completion3 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Chronic UrticariaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bharat Serums and Vaccines Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Innvocept Global Solutions Private Limited
- Responsible party
- Sponsor
- Investigators
- Dr Saswata Banerjee, Study director, Bharat serums and Vaccines LTd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07680413
- Sponsor's protocol ID
- BSV/HIST/01/2025
- Other IDs
- CTRI/2025/12/099964
- Acronym
- RUSH
- Status last verified
- Sep 2026
- First submitted
- 6 Jun 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 24223585Friedman 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.
PubMed 38758422Sivanandhan 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07680413
- Acronym / sponsor ID
- RUSH / BSV/HIST/01/2025
- Conditions
- Chronic Urticaria
- Keywords
- Histoglob, urticaria, histaglobulin, Chronic urticaria, RWE study, antihistaminics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Bharat Serums and Vaccines LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Innvocept Global Solutions Private Limited
- Study start
- 31 Dec 2025 (actual)
- Primary completion
- 3 Aug 2026 (actual)
- Study completion
- 3 Aug 2026 (actual)
- First posted
- 2 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Chronic Urticaria Group | – | Drug: Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) InjectionPatients with Chronic Urticaria on the first line of treatment like antihistaminics and not controlled requiring histaglobulin treatment |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Male or female patients aged above 13 years diagnosed with chronic urticaria with UAS7
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antihistaminics, H2 blockers, Leukotriene antagonists, Immunoglobulin/Histamine Complex (IHC) InjectionHistaglobulin prefilled syringe is administered subcutaneously as a single 1mL dose. | Drug | Chronic Urticaria Group |
Primary outcome
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7)
Time frame: End of study, approximately 1 year
Proportion of patients achieving UAS7 <7
3 secondary outcomes
Requirement of Antihistamine ± other non-biologic anti-allergic medications (Pill Burden):
Time frame: baseline to 2 months
3. Change in Quality of Life:
Time frame: Baseline to 2 months
4. Safety and Tolerability:
Time frame: Throughout the study period, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Background: PubMed 24223585Khan 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.
- Background: PubMed 38758422Friedman 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.
- BackgroundSivanandhan 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
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dr Saswata Banerjee study director
Bharat serums and Vaccines LTd
40 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Urticaria, run by Bharat Serums and Vaccines Limited at 40 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 40 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in clinical improvement as assessed by Urticaria Activity Score (UAS7) (time frame: End of study, approximately 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07680413, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.