CTRI

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CTRI Number

CTRI/2025/12/099964 [Registered on: 29/12/2025] Trial Registered Prospectively

Last Modified On:

24/08/2026

Post Graduate Thesis

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

Primary Sponsor

Name	Bharat Serums and Vaccines Limited
Address	3rd Floor, Liberty Tower, Airoli, Navi Mumbai, Thane – 400 708
Type of Sponsor	Pharmaceutical industry-Indian

Details of Secondary Sponsor

Name	Address
NIL	NIL

Countries of Recruitment

India

Sites of Study
Modification(s)

No of Sites = 45
Name of Principal Investigator	Name of Site	Site Address	Phone/Fax/Email
Dr Satish K	KR hospital	KR Hospital. Room no.: 14(Dermatology Department), 1st floor, OPD BuildingMMC&RI, Irwin road., Mysore, 570001, Karnataka Mysore KARNATAKA	9886400414 drsatishkeshav@gmail.com
Dr Eshwari L	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	9810042030 poojachopra74@gmail.com
Dr Urvi Panchal	Aarvya Hospital	Ground Floor, Room No.3, Dermatology Department, sector 90Gurugram, Haryana, 122505 Gurgaon HARYANA	8800827110 drurvi77@gmail.com
Dr Rashmi Chavan	Anand Multispeciality Hospital	PMT Chowk, Pune-Nashik Road , Bhosari, Pune-411039 Pune MAHARASHTRA	9742256888 drrashmi77.reserach@gmail.com
DrNeetu	Apex Hospital Pvt. Ltd.	SP 4&6, Malviya nagar Industrial Area, Malviya Nagar, Jaipur, 302017 Jaipur RAJASTHAN	9829335095 drneetusidana95@gmail.com
Dr Shraddha Patil	Ayushri Multispeciality Hospital.	Ground floor, OPD No. 1, Samadhan Chowk, Pimpri Gaon, Pune 411017 Pune MAHARASHTRA	7709502751 drshraddhapatil27@gmail.com
Dr Indu Ballani	Ballani Skin, Hair and Nail Clinic	Ballani Skin Aesthetics Flat No 59 Bhagat Singh Market Near Gole Market New Delhi Delhi 110001 India New Delhi DELHI	9650031223 drinduballani@gmail.com
Pawan Singh	Chandni Hospital Private Limited	9/60 arya Nagar , Kanpur - 208002 South DELHI	8840505253 drpawans615@gmail.com
Emy Elzy Alexander	Christian Medical Collage & Hospital	Department of Dermatology, room no. 1, 2nd floor Brown Road Ludhiana Ludhiana Punjab - 141008 India Ludhiana PUNJAB	7087282878 emyabi@gmail.com
Dr Emy abhi Thomas	Christian Medical Collage and Hospital	Dept. of Dermatology, Christian Medical Collage, Ludhiana, Brown Road, Punjab Ludhiana PUNJAB	7087232578 emyabi@gmail.com
Dr Godse Kiran Vasant	D Y Patil Hospital	5th Floor, Research Department, Sector-5,Nerul, Navi Mumbai, Thane, Mahararashtra, 4007006, India Thane MAHARASHTRA	9322266687 drgodse@gmail.com
Dr Abhishek De	Department of Skin & V.D S.P Medical Collage & A.G of Hospital	Department of Skin & V.D S.P Medical Collage & A.G of Hospital, 32,Garachand Road , Beniapukur Kolkata WEST BENGAL	7044904682 eshwaril@yahoo.com
Dr Vaibhav	Dr Vaibhav Skin , Hair and Laser Clinic	Dr Vaibhav Skin, Hair and Laser Clinic, Janakpuri, C-126, Ganesh Nagar,Delhi New Delhi DELHI	99992 41161 vm_17.75@rediff.com
Dr Astha Sharma	Dr Astha Sharma Clinic	Dr Astha Sharma Clinic, Chamber no.6,A-2/7, Pankha Road , Block A2, Janakpuri, New Delhi,110058 New Delhi DELHI	8595540359 drastha.sharma@gmail.com
Dr Utsa Basu	Dr Utsa Basus Clinic	65a, Middle road, Kol-14, Entally Philips More, kolkata, West Bengal Kolkata WEST BENGAL	9432658968 dubclinicalresearchcenter@gmai;.com
Dr Ruchika Garg	DRG Skin Clinic	C/O Shiddhivinayak Polyclinic Sector 2/C Faridabad Faridabad HARYANA	9582354366 ruchikagarg144@gmail.com
Dr Kingshuk Chatterjee	Ethics Committee NRS Medical College and Hospital	2nd floor, opd building, room no. 2, Department of Darmatology, 138, A.J Bose Road, Raja Bazam, Kolkata, West Bengal, 700014 Kolkata WEST BENGAL	9932641801 klose2kingonly@gmail.com
Dr Anil Ganjoo	Innovation Clinics	Skinnvovation The World of Aesthetics B11 Gujranwala Town Delhi 110009 India North DELHI	9811066584 drganjoo1965@gmail.com
Dr Amruta Kulkarni	Ishwar Institute of Healthcare	,Ishwar Heights, 1st Floor, Punjab Bhavan, Padgaon, Aurangabad-431002 Aurangabad MAHARASHTRA	9822314260 dramruta.iicn@gmail.com
Dr Rajkumar Kothiwal	Jawahar Lal Nehru hospital	ground floor, Room no 34 CJawahar Lal Nehru medical college, Kala Bagh, Ajmer, Rajasthan, 305001 Ajmer RAJASTHAN	9414118811 drkothiwala@gmail.com
Dr Ghanshyam Vinod	Jupiter Hospital and Research Centre	Opposite ICAI Bhavan, Sun Pharma - Atladara Road, Vadodara, Gujarat- 390012, India Vadodara GUJARAT	9824488194 dr.ghanshyam.vinodnm@gmail.com
Dr Sowmya CS	KIMS Hospital	K R Road, V V Puram, Bangalore, Karnataka, 560004 Bangalore KARNATAKA	9611116181 kimsowmya@gmail.com
Dr Anupam Das	KPL Hospital	"Room no. 54, Block 2, ground floor, Department of Dermatology Lakewood Estate, 266 Gaaragachha, Tower 1, Flat 11b,Kolkata- 700084" Kolkata WEST BENGAL	9674852138 anupamdasdr@gmail.com
Dr Anvita Solankhi	L. G Hospital	Lala Lajpat Marg, Maninagar, Ahmedabad, 380008 Ahmadabad GUJARAT	9660604041 dranvitasolanki@gmail.com
Dr Sonal Shendkar	Lifepoint Multispeciality Hospital	Sr No. 145/1, Mumbai-Banglore Highway, Near Hotel Sayaji , Wakad, Pune - 411057 Pune MAHARASHTRA	9960178611 shendkar.sonal82@gmail.com
Dr Manisha Nijhawan	Mahatma Gandhi Hospital	Basement , Room no:- 2, Department of dermatology Venerology & Leprosy, Jaipur, RIICO Industrial Area, Sitapura Tonk Road, Jaipur, 302022 Jaipur RAJASTHAN	9314503401 m.nijhawan12@gmail.com
Dr Ishan Asutosh Pandya	Matis Multispeciality Hospital	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	Behind LIC Office, Bafina Road, Nanded-431602, Maharashtra , India Nanded MAHARASHTRA	9727706126 drnitin.research@gmail.com
Dr Sandeep Babbar	Revyve Skin Hair and Nail clinic	12 GF Ozone Centre Sector 12 Faridabad Haryana 121002 India Faridabad HARYANA	9810317213 drsandeepbabbar@gmail.com
Dr Vijay Warad	Sai Allergy Asthma Eye Hospital	102, A 2 wing, Inside Society of Arneshwar park Phase 2, ICICI Bank, Sahkar Nagar, Parwati, Pune -Satara Rd, Pune- 411009,Maharashtra Pune MAHARASHTRA	9822436184 vijaypwarad@gmail.com
Dr Avinash Jadhav	Saikrupa Hospital	Renuka Corner , Tapkir Chowk , Thergaon , Pune Pune MAHARASHTRA	8669665033 skresearch07@gmail.com
Dr Anand Sarwade	Shripad Multispecialty Hospital	1st & 2nd Floor, Kate square building, Katepuram chowk, opposite to Nilu Phule Natyagruh, Phase 2, Kate Puram, Pimple Gurav, Pune, Pimpri-Chinchwad, Maharashtra 411061, India. Pune MAHARASHTRA	8983236487 dr.sarwade.ivora@gmail.com
Dr Shobhita Gupta	Silver Streak Multispeciality Hospital	Oppo DLF the Sky Court, Sector 87, Gurugram , Haryana Gurgaon HARYANA	9910520522 care@silverstreakhospital.com
Dr Parul Garg	Skin & Hair Clinic (Aesthetic Clinic)	159 A, NCR Clock C4H, Janakpuri, New Delhi, 110058 New Delhi DELHI	8006578807 dr.parulgarg14@gmail.com
Dr Surender Kumar Thalor	SMS Medical Collage and Hospital	JNN Marg, Jaipur, rajasthan, 302004 Jaipur RAJASTHAN	9660604041 urenbhu2001@gmail.com
Dr Indrashis Poddere	UPASANA DIAGNOSTIC CENTRE	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	9822400964 drpvaidya@gmail.com
Dr vaishnavi Modi	Vaishnavis skin Care & Cosmetic	406, Asthamangal Complex , Shahibaug ,Ahmedabad Ahmadabad GUJARAT	8469999063 gangwalavaishnavi80@gmail.com
DrRachna	Venkateshwar Hospital	Sector 18A, Dwarka, New Delhi, 110075 South West DELHI	882660877 drrachna77@yahoo.co.in

Details of Ethics Committee
Modification(s)

No of Ethics Committees= 30
Name of Committee	Approval Status
Aakash Institutional Ethics committee	Submittted/Under Review
Central Independent Ethics Committee	Approved
Central Independent Ethics Committee	Approved
Central Independent Ethics Committee	Approved
Central independent Ethics committee	Submittted/Under Review
Central Independent Ethics Committee	Approved
Ethics Committee NRS Medical College and Hospita	Submittted/Under Review
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
Renukai Institutional Ethics Committee	Approved
Saarthak Ethical Research	Approved
Saarthak Ethical Research	Approved
Saarthak Ethical Research	Approved
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)

Closed to Recruitment of Participants

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 through routine 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).