CTRI/2025/12/099964 [Registered on: 29/12/2025] Trial Registered Prospectively
Last Modified On:
26/03/2026
Post Graduate Thesis
No
Type of Trial
Observational
Type of Study
Real-world Evaluation and prospective
Study Design
Single Arm Study
Public Title of Study
A real-world observational study on how effective the medicine Histoglob is for treating chronic urticaria
Scientific Title of Study
Real-world Evaluation of the Effectiveness of Immunoglobulin-Histamine Complex ; IHC (Histoglob) in the Management of Chronic Urticaria: A Prospective, Multicenter, Observational Study
Trial Acronym
RUSH (Real World Urticaria Study with Histoglob)
Secondary IDs if Any
Secondary ID
Identifier
BSV/HIST/01/2025, Version 1.0,14 Nov 2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Saswata Banerjee
Designation
Assistant Vice President, Medical Affairs
Affiliation
Bharat Serums and Vaccines Limited (BSV)
Address
3rd Floor, Liberty Tower, Airoli, Navi Mumbai, Thane
Thane MAHARASHTRA 400708 India
Phone
9831028166
Fax
Email
saswata.banerjee@bsvgroup.com
Details of Contact Person Scientific Query
Name
Dr Falgun Vyas
Designation
General Manager, Medical Affairs
Affiliation
Bharat Serums and Vaccines Limited
Address
3rd Floor, Liberty Tower, Airoli, Navi Mumbai, Thane
Thane MAHARASHTRA 400 708 India
Phone
8866717199
Fax
Email
Falgun.vyas@bsvgroup.com
Details of Contact Person Public Query
Name
Dr Manish Rajak
Designation
Chief Executive Officer
Affiliation
Innvocept Global Solutions Private Limited
Address
1002, Floor 10, Duct 1, Solus Building, TMC Lake Garden, Hiranandani Estate, Thane, Maharashtra, India.
Thane MAHARASHTRA 400607 India
Phone
7680074619
Fax
Email
manish.rajak@innvoceptsolutions.com
Source of Monetary or Material Support
Bharat Serums and Vaccines Limited (BSV), 3rd Floor, Liberty Tower, Airoli, Navi Mumbai, Thane – 400 708
SkinXperts Super Speciality Skin, Hair and Laser Clinic
107, 6th Main, near Chaitanya school , 2nd stage, Mahalakshmi Layout, Bangalore, 560086 - Karnataka Bangalore KARNATAKA
9845935375
eshwaril@yahoo.com
Dr Pooja Chopra
Aakash Healthcare Super Speciality Hospital
1st floor, Room no- 06, Department of Dermatology, Aakash Healthcare Super Speciality Hospital.
Hospital Plot Road No. 201, Sector 3, Dwarka, New Delhi, 110075
North West DELHI
Department of Dermatology, Matis Multispeciality Hospital.
Opposite Adani CNG Gas station, Near Motera BRTS Bus stop,
Motera, Ahmedabad, Gujarat, 380005
Ahmadabad GUJARAT
98240727535
ishanpandya29@gmail.com
Dr Poonam Bhangle
Medipoint Hospital
Floor 1st, 241/1, New D.P Road, Research Department Aundh, pune-411007, Maharashtra, India Pune MAHARASHTRA
9727800909
drpoonam.medipoint@gmail.com
Dr Priyanka Trimbak Kokane
Mediskin Hospital
Skin OPD, Room no. 1, ground floor, department of medicine, Baramati, Galinde Colony,Samarth Nagar,Behind Bus Stand,Ring road, Baramati,Pune-413102, Maharashtra India Pune MAHARASHTRA
8600386300
drkokanepriyanka@gmail.com
Dr Monika Gowda
Medstar Speciality Hospital
641/17/1/3, Kodigehalli Main Road, Sahakar Nagar, Banglore-560092, Karnataka, India Bangalore KARNATAKA
9884457106
drmonikagowda.medstar@gmail.com
Dr Sanjay Kumar mittal
Mittal Skin Hair Laser and Cosmetic
G-26/27, Vidhyadhar Enclave-2, Central Spine, Near Axis Bank ,Vidhyadhar Nagar Jaipur, Rajasthan- 302039 Jaipur RAJASTHAN
9887760605
dr-sanjay25@yahoo.com
Dr Kalpesh Kharva
Parikh Multispeciality Hospital
A/4 Bhagwadti Park, Opp. Tube Company, Near Gajanan Complex, Old Padra Road, Vadodara, Gujarat, India- 390020 Vadodara GUJARAT
9925059377
drkalpeshkharvanm@gmail.com
Dr Nitin Wathore
Renukai Critical Care and Multispeciality Hospital
UPASANA DIAGNOSTIC CENTRE , Ground Floor
Number 3 Island / Circle, AD 71, 1st Ave Rd, near bd bus stand or, AD Block, Sector 1, Bidhannagar, Kolkata, West Bengal 700064 Kolkata WEST BENGAL
9007977161
ipodder88@gmail.com
Dr Pradyumna Vaidya
Vaidya Skin Care Clinic
Room No. 01 First floor,Bendre Niwas, Perugate, Sadashiv peth Pune -411030, Maharashtra Pune MAHARASHTRA
Good Society for Ethical Research – Independent Ethical Committee (
Submittted/Under Review
IEC VENKATESHWAR HOSPITAL UNIT OF ASHA Venkateshwar Hospita
Submittted/Under Review
IEC-MMC & RI and Associated Hospitals.
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee
Submittted/Under Review
Institutional Ethics Committee Apex Hospitals
Submittted/Under Review
Institutional Ethics Committee Christian Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee KPC Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, JLN Medical college and Hospital
Submittted/Under Review
Saarthak Ethical Research LLP
Submittted/Under Review
Saarthak Ethical Research LLP
Submittted/Under Review
Shakti General Hospital
Submittted/Under Review
Shakti General Hospital
Submittted/Under Review
Shakti Hospital Ethics Committee
Approved
Skinovate Independent Ethics Committee
Approved
Skinovate Independent Ethics Committee
Approved
Skinovate Independent Ethics Committee
Submittted/Under Review
V Care Independent Ethics Committee
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L508||Other urticaria,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Nil
Nil
Inclusion Criteria
Age From
13.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Inclusion Criteria
1. Male or female patients aged 13 years and above.
2. Able and willing to provide written informed consent (or assent where applicable).
3. Diagnosed with chronic urticaria with UAS7 prior to enrollment already on first line of treatment for Chronic Urticaria
4. Prescribed Histoglob injections for the first time at the discretion of treating physician as part of routine care.
ExclusionCriteria
Details
Exclusion Criteria
1. Known allergy or hypersensitivity to Histoglob or human immunoglobulin product.
2. Patients with acute allergic attack
3. Pregnant or lactating women.
4. History of malignancy or any condition requiring immunosuppressive therapy other than study indication.
5. Participation in any other clinical study.
6. Any other condition or circumstance that, in the opinion of the study physician, makes the patient unsuitable for study participation
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
1. Change in clinical improvement as assessed by Urticaria Activity Score (UAS7):
Proportion of patients achieving UAS7 less than 7 at the end of the study period and time taken to achieve UAS7 less than 7
Mean reduction of UAS7 score (from the baseline score) at the end of the study
Proportion of patients achieving and maintaining a Urticaria Control Test (UCT) score of greater than or equal to 12 at the end of the study
Baseline, 4 weeks & 8 weeks
Secondary Outcome
Outcome
TimePoints
1. 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.
2. 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.
3. Safety & Tolerability:
Incidence, severity, & relationship of adverse events (AEs) treatment-emergent adverse events (TEAEs) & adverse drug reactions (ADRs) during the study period.
Proportion of patients discontinuing treatment due to adverse events or intolerance.
Baseline, 4 weeks & 8 weeks
Target Sample Size
Total Sample Size="600" Sample Size from India="600" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
06/01/2026
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="8" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, multicenter, non-interventional, observational, real-world evidence (RWE) study designed to evaluate the effectiveness and safety of Histoglob (Immunoglobulin-Histamine Complex; IHC) in patients with Chronic Urticaria in India. Histoglob is a sterile preparation of Histamine dihydrochloride coupled to active protein fraction extracted from human blood (Gamma-globulin) in strictly defined proportions...
Approximately 50 centers across representative geographies in India will participate, with an anticipated enrolment of around 600 patients receiving Histoglob as part of routine clinical practice.
Patients will be followed for up to 2 months (/+ 1 week) for primary effectiveness assessment, with additional follow-up as per usual clinical care to capture safety and treatment outcomes. Data will be collected throughroutine clinical records and patient-reported outcome measures without any intervention beyond standard management.
The study will be initiated after obtaining written approval of Independent Ethics Committee (IEC) /Institutional Review Board (IRB).