Comparison of efficacy and safety of two modes of Autologous Serum Therapy injection

Comparison of Efficacy and Safety of Subcutaneous versus Intramuscular Autologous Serum Therapy in Chronic Spontaneous Urticaria – A Randomized Controlled Study - NIL

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/02/062280

Enrollment

Registered

2024-02-05

Start date

Unknown

Completion date

Unknown

Last updated

2024-03-04

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

Conditions

Health Condition 1: L501- Idiopathic urticaria

Interventions

Intervention1: Subcutaneous Autologous serum therapy: 1ml of autologous serum will be given subcutaneously over lateral aspect of upper arm using an insulin syringe with 31G needle under aseptic preca

Eligibility

Inclusion criteria

Inclusion criteria: Patients of age above 18 years clinically diagnosed with chronic spontaneous urticaria and giving consent to participate in the study.

Exclusion criteria

Exclusion criteria: Pregnant and lactating women, immunocompromised patients, those on immunosuppressants for other illness

Design outcomes

Primary

Measure	Time frame
1.To compare the efficacy of subcutaneous autologous serum therapy versus intramuscular autologous serum therapy by Urticaria Activity Score (UAS7), Total Urticaria Severity Score (TSS) and Urticaria Control Test (UCT). 2. To compare the tolerability of subcutaneous autologous serum therapy versus intramuscular autologous serum therapy by likert scale.Timepoint: UAS7, TSS and UCT scores will be measured at baseline, 4th week, 9th week (end of treatment) and 12th week (follow up)	—

Measure

Time frame

1.To compare the efficacy of subcutaneous autologous serum therapy versus intramuscular autologous serum therapy by Urticaria Activity Score (UAS7), Total Urticaria Severity Score (TSS) and Urticaria Control Test (UCT). 2. To compare the tolerability of subcutaneous autologous serum therapy versus intramuscular autologous serum therapy by likert scale.Timepoint: UAS7, TSS and UCT scores will be measured at baseline, 4th week, 9th week (end of treatment) and 12th week (follow up)

—

Secondary

Measure	Time frame
Estimation of proportion of patients having anti-thyroid peroxidase antibody (TPO) in patients with chronic spontaneous urticaria.Timepoint: At baseline	—

Countries

India

Contacts

Public ContactUdayashankar C

Indira Gandhi Medical College and Research Institute

udayderm@yahoo.com9787731275

Outcome results

None listed

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