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Usefulness and safety of conventional and modified self-serum therapy in long standing generalised itch and wheals of skin

Subcutaneous autologous serum therapy vs. conventional Intramuscular autologous serum therapy in chronic urticaria: A randomised, controlled trial comparing the effectiveness and safety - SCIMAST

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2016/05/006907
Enrollment
64
Registered
2016-05-06
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: null- All patients clinically diagnosed as Chronic Urticaria aged 18 yrs and above and not responding to a single daily dose of second generation antihistamine after 2 weeks of therapy

Interventions

Intervention1: Subcutaneous Injection of Autologous Serum Therapy: Five ml venous blood of the patient will be drawn with a sterile, disposable syringe from the antecubital vein in a sterile Vacutaine

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All patients presenting with chronic urticaria aged above 18 years and symptoms not responding to a single daily dose of second generation antihistamine after 2 weeks of therapy.

Exclusion criteria

Exclusion criteria: Pregnant and lactating ladies Immunosuppressed due to drug or disease Allergy to Cetirizine Concomitant systemic illness requiring treatment Mental illness interfering with perception of urticarial symptoms

Design outcomes

Primary

MeasureTime frame
Clinical effectiveness of subcutaneous autologous serum therapy versus conventional intramuscular serum therapy in cases of chronic urticaria 1. By Urticaria Severity Score (USS) 2. By Total Severity Score (TSS)Timepoint: Baseline, 1, 2, 3, 4, 5, 6, 7, 8, 12, 16, 20, 24, 28 and 32 weeks after randomization

Secondary

MeasureTime frame
A. Safety of two treatment arms 1. By checklist for adverse events 2. CDSCO ADR reporting form 3. Laboratory investigations B. Quality of life in the two treatment arms by Dermatology Life Quality Index (DLQI)Timepoint: Baseline and at 8 weeks and 32 weeks after randomization

Countries

India

Contacts

Public ContactDr Adrija Datta

Department of Dermatology

drdasnilay@gmail.com9433394148

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026